--- title: "MDR — Medical Devices Regulation" description: "The Medical Devices Regulation governs medical devices, their accessories and Annex XVI products on the EU market, from classification and notified-body assessment to CE marking, Eudamed and vigilance, for manufacturers, importers and distributors. It has applied since 26 May 2021; directive-certified devices may stay on the market until 31 December 2027 or 2028 under Regulation (EU) 2023/607." type: "guide" url: "https://www.conphora.com/regulations/mdr/" markdown: "https://www.conphora.com/regulations/mdr.md" locale: "en" language: "en" published: "2017-05-25" updated: "2026-09-11" author: "Conphora compliance team" publisher: "Conphora" reference: "Regulation (EU) 2017/745" celex: "32017R0745" source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745" tags: ["MDR", "Medical Devices"] license: "Free to quote with attribution and a link to the page" --- # MDR — Medical Devices Regulation The Medical Devices Regulation governs medical devices, their accessories and Annex XVI products on the EU market, from classification and notified-body assessment to CE marking, Eudamed and vigilance, for manufacturers, importers and distributors. It has applied since 26 May 2021; directive-certified devices may stay on the market until 31 December 2027 or 2028 under Regulation (EU) 2023/607. ## Key facts - **Official title:** Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC - **Reference:** Regulation (EU) 2017/745 - **CELEX:** 32017R0745 - **Act type:** Regulation - **In force:** 2017-05-25 - **Applies from:** 2021-05-26 - **Enforced by:** National competent authorities for medical devices carry out the market surveillance under Chapter VII of the regulation; in Denmark that is Lægemiddelstyrelsen (the Danish Medicines Agency), which supervises manufacturers and the other economic operators, handles incident reports, verifies the Eudamed actor registrations that lead to a single registration number and registers Danish distributors and specialist retailers, under the Danish act on medical devices (lovbekendtgørelse nr. 682 af 29. maj 2023, as amended by lov nr. 1759 af 29. december 2025), whose § 3 names Lægemiddelstyrelsen as the competent authority, bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (in force 1 January 2026) and the fee orders bekendtgørelse nr. 839 af 20. juni 2023 (as amended) and bekendtgørelse nr. 1733 af 8. december 2025. The toolkit is documentation and sample requests, announced and unannounced inspections, corrective action within a set period, restriction or prohibition of the making available, withdrawal, recall, confiscation or destruction of devices presenting an unacceptable risk or falsified devices, measures against formal non-compliance, and national penalties that must be effective, proportionate and dissuasive. - **Category:** Medical Devices ## Who it applies to **Covered by the act:** Medical devices for human use: any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease or injury, investigation or replacement of the anatomy or a physiological process, or in vitro information from specimens, without a principal pharmacological, immunological or metabolic action; Accessories for medical devices, devices for the control or support of conception, and products intended for cleaning, disinfecting or sterilising devices; The six groups of products without a medical purpose in Annex XVI (contact lenses, aesthetic implants, dermal fillers, liposuction and lipolysis equipment, IPL and laser skin equipment, brain-stimulation equipment), from the date of application of their common specifications; Devices placed on the market, made available or put into service in the Union, including devices offered online to persons in the Union and devices used to provide diagnostic or therapeutic services at a distance; The economic operators: manufacturers, authorised representatives, importers, distributors and the persons who put systems or procedure packs together **Derived and downstream products:** Software with a medical purpose is a medical device and an active device in its own right; software that drives or influences another device takes that device's class (Art. 2(1) and (4), Annex VIII, Section 3.3); A distributor, importer or other person that sells a device under its own name or trade mark, changes its intended purpose or modifies it in a way that may affect compliance takes on the manufacturer's obligations, and so does anyone who reprocesses a single-use device (Art. 16 and Art. 17(2)); Devices with both a medical and a non-medical purpose must meet both sets of requirements cumulatively (Art. 1(3)); A device incorporating an in vitro diagnostic as an integral part is governed by the MDR, with the IVDR applying to the IVD part; a device with an ancillary medicinal substance is assessed under the MDR, but where the medicinal action is principal the combination falls under the medicinal products rules (Art. 1(7) to (9)); Devices that are also machinery must additionally meet the more specific essential requirements of the Machinery Directive, and the regulation is specific legislation for the purposes of the EMC Directive (Art. 1(11) and (12)); Legacy devices placed on the market under Article 120(3a) or (3b) are already subject to the MDR rules on post-market surveillance, market surveillance, vigilance and registration of operators and devices (Art. 120(3d)) **Roles under the act:** - **Manufacturer (including own-brand sellers and reprocessors)** — A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark; a distributor, importer or other person that sells under its own name, changes the intended purpose or modifies a device in a way that may affect compliance, and anyone who reprocesses a single-use device, assumes the manufacturer's obligations. - **Authorised representative** — Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union to act on the manufacturer's behalf in relation to specified tasks under the regulation; a non-EU manufacturer may place devices on the Union market only if it designates a sole authorised representative. - **Importer** — Any natural or legal person established within the Union that places a device from a third country on the Union market. - **Distributor (wholesaler, pharmacy, retailer)** — Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service. ## Key dates - 2017-04-05: Regulation (EU) 2017/745 adopted by the European Parliament and the Council in Strasbourg; published in OJ L 117 on 5 May 2017 - 2017-05-25: Entry into force, the twentieth day after publication in the Official Journal - 2017-11-26: Articles 35 to 50 on notified bodies and Articles 101 and 103 on the Medical Device Coordination Group apply, so that bodies could be designated under the regulation before the date of application - 2019-05-26: GS1, HIBCC and ICCBBA are deemed designated UDI issuing entities until the Commission designates entities under Article 27(2) - 2020-04-24: Regulation (EU) 2020/561 in force on the day of publication: the date of application is postponed by one year to 26 May 2021 because of COVID-19, and the Article 59 derogation procedure applies immediately - 2021-05-26: The regulation applies; Directives 90/385/EEC and 93/42/EEC are repealed and notifications of notified bodies under them become void; the UDI carrier must appear on the labels of implantable and class III devices - 2022-05-27: Certificates issued under Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC (EC verification) become void at the latest - 2023-03-11: Delegated Regulation (EU) 2023/502 in force: complete re-assessment of notified bodies every 5 years instead of 3 years after notification and every 4 years thereafter - 2023-03-20: Regulation (EU) 2023/607 in force on the day of publication: directive certificates still valid on 26 May 2021 remain valid until 31 December 2027 or 31 December 2028 depending on risk class, and the sell-off deadline of Article 120(4) is removed - 2023-05-26: UDI carrier required on the labels of class IIa and IIb devices, and directly on reusable implantable and class III devices that must bear the carrier on the device itself - 2023-11-09: Delegated Regulation (EU) 2023/2197 in force: Master UDI-DI for contact lenses added to Annex VI, Part C, applicable from 9 November 2025 - 2024-02-15: Regulation (EU) 2024/568 on fees payable to the European Medicines Agency in force the day after publication; it replaces Article 106(14) on fees for expert-panel advice and applies from 1 January 2025 - 2024-05-26: Deadline for legacy-device manufacturers to have a quality management system under Article 10(9) and to lodge a formal application with a notified body, and for class III custom-made implantable devices to apply for conformity assessment - 2024-07-09: Regulation (EU) 2024/1860 in force on the day of publication: gradual roll-out of Eudamed module by module, new Article 10a on supply interruptions, Article 120(8) deleted - 2024-09-26: Deadline for the written agreement between the legacy-device manufacturer and its notified body; from this date that notified body is responsible for surveillance of the devices covered - 2025-01-10: Article 10a applies: manufacturers must give at least 6 months' notice of an anticipated interruption or discontinuation of supply that could cause serious harm - 2025-05-26: UDI carrier required on the labels of class I devices, and directly on reusable class IIa and IIb devices that must bear the carrier on the device itself - 2025-10-13: Delegated Regulation (EU) 2025/1920 in force: Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles, applicable from 1 November 2028 - 2025-11-09: Master UDI-DI rules for standard and made-to-order contact lenses apply (Annex VI, Part C, Section 6.6.1) - 2025-11-27: Commission Decision (EU) 2025/2371 published: the Eudamed modules for actors, UDI and devices, notified bodies and certificates, and market surveillance are confirmed functional, starting the 6-, 12- and 18-month clocks of Article 123(3) - 2026-01-01: Regulation (EU) 2025/2457 in force: Annex I, Section 10.4 now refers to Category 1 endocrine disruptors under the CLP Regulation and ECHA takes over the guidelines on phthalates and other CMR or endocrine-disrupting substances - 2026-05-26: End of the derogation for class III custom-made implantable devices: from this date they need a notified-body certificate under Article 52(8), second subparagraph - 2026-05-28: Mandatory use of the first four Eudamed modules (actor registration, UDI and device registration, notified bodies and certificates, market surveillance); manufacturers, authorised representatives and importers register in Eudamed instead of national databases - 2026-07-19: Delegated Regulations (EU) 2026/1359 and 2026/1451 in force: longer lists of well-established class IIb implantable devices exempt from device-by-device technical-documentation assessment and of implantable and class III devices exempt from mandatory clinical investigations - 2026-11-28: Deadline (12 months from the Eudamed notice) for manufacturers to have entered in Eudamed the Article 29 information on devices placed on the market from 28 May 2026, including legacy devices under Article 120(3), (3a) and (3b) - 2027-05-26: UDI carrier required directly on reusable class I devices that must bear the carrier on the device itself - 2027-05-27: Deadline for the Commission's evaluation report on the application of the regulation, with special attention to UDI storage and traceability - 2027-05-28: Deadline (18 months from the Eudamed notice) for notified bodies to have entered their certificates in Eudamed; the duties to upload the summary of safety and clinical performance and to notify certificates follow the certificate entry - 2027-12-31: End of the transitional period for legacy class III devices and class IIb implantable devices other than sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors - 2028-11-01: Master UDI-DI rules for spectacle frames, spectacle lenses and ready-to-wear reading spectacles apply (Annex VI, Part C, Section 6.6.2) - 2028-12-31: End of the transitional period for the other legacy class IIb devices, class IIa devices, class I devices placed on the market sterile or with a measuring function, and class I devices up-classified by the regulation ## What you must do ### Manufacturer (including own-brand sellers and reprocessors) - Design and manufacture the device to the general safety and performance requirements of Annex I for its intended purpose, run a documented risk management system, and demonstrate conformity through a clinical evaluation under Article 61 and Annex XIV, including post-market clinical follow-up; for implantable and class III devices a clinical investigation is required unless one of the Article 61(4) to (6) exceptions applies, whose list of well-established devices was extended by Delegated Regulation (EU) 2026/1451. - Design and manufacture the device so that it meets the general safety and performance requirements of Annex I that apply to it, taking its intended purpose into account. - Establish, document, implement and maintain a risk management system for the device, as a continuous process throughout its lifecycle. - Conduct a clinical evaluation under Article 61 and Annex XIV, including post-market clinical follow-up; for implantable and class III devices run a clinical investigation unless an Article 61(4) to (6) exception applies, whose list of well-established devices Delegated Regulation (EU) 2026/1451 extended. - Classify the device into class I, IIa, IIb or III using the 22 rules of Annex VIII and run the matching conformity assessment before placing it on the market: Annex IX (or Annex X with Annex XI) for class III; Annex IX with technical-documentation assessment of a representative device per generic device group for class IIb, and of every device for class IIb implantables other than the well-established types listed in Article 52(4); Annex IX or Annex XI for class IIa; the EU declaration of conformity alone for class I, except that sterile, measuring and reusable surgical class I devices need a notified body for those aspects. - Classify the device into class I, IIa, IIb or III using the 22 classification rules of Annex VIII. - Before placing the device on the market, run the conformity assessment procedure of Article 52 for its class: a notified body under Annex IX, X or XI for classes IIa, IIb and III, and self-declaration for class I, with a notified body for sterile, measuring and reusable surgical aspects. - Draw up and keep up to date the technical documentation of Annexes II and III (or the Annex XIII documentation for custom-made devices), draw up the EU declaration of conformity with the Annex IV content and the Basic UDI-DI, affix the CE marking followed by the notified body's number where applicable, and keep the documentation, declaration and certificates available to authorities for at least 10 years after the last device was placed on the market, 15 years for implantables. - Draw up and keep up to date the technical documentation of Annexes II and III, or the Annex XIII documentation for custom-made devices. - Draw up the EU declaration of conformity with the Annex IV content and the Basic UDI-DI, and keep it up to date. - Affix the CE marking to the device, followed by the identification number of the notified body where a notified body was involved in the conformity assessment. - Keep the technical documentation, the EU declaration of conformity and any certificates available to the competent authorities for at least 10 years after the last device covered by the declaration was placed on the market, and 15 years for implantable devices. - Operate a quality management system proportionate to the risk class that covers regulatory strategy, risk management, clinical evaluation, product realisation, UDI, post-market surveillance, vigilance and corrective actions, keep series production in conformity, and have at least one person responsible for regulatory compliance with the Article 15 qualifications in the organisation, or permanently at your disposal if you are a micro or small enterprise. - Operate and keep up to date a quality management system, proportionate to the risk class and type of device, that covers the elements of Article 10(9) and keeps series production in conformity. - Have within your organisation at least one person responsible for regulatory compliance with the Article 15 qualifications or, as a micro or small enterprise, have such a person permanently and continuously at your disposal. - Assign a UDI (UDI-DI and UDI-PI) from a designated issuing entity to every device other than custom-made and investigational devices and to all higher packaging levels, place the UDI carrier on the label and packaging within the staggered dates of Article 123(3), keep a list of all UDIs in the technical documentation, and assign a Basic UDI-DI and submit the Annex VI core data to the UDI database before placing the device on the market. - Assign a UDI (UDI-DI and UDI-PI) from a designated issuing entity to each device other than custom-made and investigational devices and to higher packaging levels, place the UDI carrier on the label and packaging by the Article 123(3) dates, and keep the list of UDIs in the technical documentation. - Assign a Basic UDI-DI and submit the Annex VI core data to the UDI database before placing the device on the market. - Register as an actor in Eudamed to obtain a single registration number before placing a device on the market (and before applying to a notified body), update the data within one week of any change, confirm it after one year and every second year, and register each device in Eudamed: the registration modules are mandatory from 28 May 2026 and devices placed on the market from that date must be entered no later than 28 November 2026. - Register as an actor in Eudamed to obtain a single registration number before placing a device on the market and before applying to a notified body. - Update your Eudamed actor data within one week of any change, and confirm its accuracy one year after registration and every second year thereafter. - Register each device in Eudamed: the registration modules are mandatory from 28 May 2026, and devices placed on the market from that date must be entered no later than 28 November 2026. - Supply the label and instructions for use with the Annex I, Section 23 information in the official language(s) of the Member State where the device reaches the user or patient, with indelible and legible label particulars; provide an implant card and patient information with implantable devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors); and draw up a summary of safety and clinical performance for implantable and class III devices, validated by the notified body and published in Eudamed. - Supply the label and instructions for use with the Annex I, Section 23 information in the official language(s) of the Member State where the device reaches the user or patient, with indelible and legible label particulars. - Provide an implant card and the Article 18 patient information with implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. - For implantable and class III devices other than custom-made or investigational devices, draw up a summary of safety and clinical performance, validated by the notified body and published in Eudamed. - Plan, run and update a post-market surveillance system with a plan in the technical documentation, and produce a post-market surveillance report for class I devices or a periodic safety update report for class IIa (at least every two years) and class IIb and III (at least annually), submitted through Eudamed to the notified body for class III and implantable devices. - Plan, run and keep up to date a post-market surveillance system proportionate to the risk class, based on a post-market surveillance plan that is part of the technical documentation. - Produce a post-market surveillance report for class I devices, or a periodic safety update report for class IIa (at least every two years) and classes IIb and III (at least annually), submitted through Eudamed to the notified body for class III and implantable devices. - Report serious incidents through the vigilance system immediately and no later than 15 days after becoming aware, 2 days for a serious public health threat and 10 days for a death or unanticipated serious deterioration in health; report field safety corrective actions in advance except in urgent cases, issue field safety notices to users, investigate incidents, submit trend reports for statistically significant increases in non-serious incidents, and provide a final report. - Report each serious incident to the competent authority immediately and no later than 15 days after becoming aware, 2 days for a serious public health threat and 10 days for a death or unanticipated serious deterioration in health; investigate it and provide a final report. - Report each field safety corrective action to the competent authorities before undertaking it, except in urgent cases, and bring it to the users' attention without delay through a field safety notice. - Report any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or in expected undesirable side-effects, that could significantly affect the benefit-risk analysis. - Take immediate corrective action, withdrawal or recall where a device you placed on the market does not conform, inform distributors, the authorised representative and importers, and where the device presents a serious risk inform the competent authorities and the notified body; on request provide all conformity information in the language the Member State determines, samples or access, and cooperate on risk-mitigation measures; keep proportionate financial coverage for product liability. - Where a device you placed on the market does not conform, immediately take corrective action, withdraw or recall it, inform distributors, the authorised representative and importers, and where it presents a serious risk inform the competent authorities and the notified body. - On a competent authority's request, provide all information and documentation demonstrating conformity in the language the Member State determines, provide samples or access to the device, and cooperate on measures to eliminate or mitigate risks. - Have measures in place to provide sufficient financial coverage for your potential liability for defective devices, proportionate to the risk class, type of device and size of the enterprise. - Give the competent authority of your or your authorised representative's Member State and your direct customers, health institutions and healthcare professionals at least 6 months' notice of an anticipated interruption or discontinuation of supply of a device, other than a custom-made device, that could foreseeably cause serious harm to patients or public health, stating the reasons; the duty applies since 10 January 2025 and covers legacy devices. - If you are established outside the Union, designate a sole authorised representative under a written mandate covering at least the Article 11(3) tasks and keep the documentation permanently available to it; if you combine CE-marked devices into systems or procedure packs, draw up the Article 22 statement and register the pack; and do not use claims, names or pictures that mislead on intended purpose, safety or performance. - If you are established outside the Union, designate a sole authorised representative under a written mandate covering at least the Article 11(3) tasks, and keep the technical documentation permanently available to it. - If you combine CE-marked devices, or devices with other products, into a system or procedure pack, draw up the Article 22 statement and register the pack. - Do not use text, names, trademarks, pictures or signs in labelling, instructions, making available or advertising that mislead the user or patient on the device's intended purpose, safety or performance. ### Authorised representative - Accept the written mandate, which is effective at least for all devices of the same generic device group, perform the tasks it specifies and provide a copy to the competent authority on request; the mandate cannot delegate the manufacturer's core duties in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). - Verify that the EU declaration of conformity and technical documentation have been drawn up and that the applicable conformity assessment was carried out, and keep a copy of the technical documentation, the declaration and any certificate at the disposal of the competent authorities for 10 years after the last device, 15 years for implantables. - Verify that the EU declaration of conformity and the technical documentation have been drawn up and that the manufacturer has carried out the applicable conformity assessment procedure. - Keep a copy of the technical documentation, the EU declaration of conformity and any certificate at the disposal of the competent authorities for 10 years after the last device was placed on the market, and 15 years for implantable devices. - Register in Eudamed to obtain your own single registration number, verify that the manufacturer has met its UDI and device registration obligations, and keep your actor data updated and confirmed. - Register in Eudamed to obtain your own single registration number, and keep your actor data updated and confirmed. - Verify that the manufacturer has complied with its UDI and registration obligations for the device and for itself. - On request, provide the competent authority with all information and documentation demonstrating conformity in the language it determines, forward requests for samples or access to the manufacturer and verify that the authority receives them, and cooperate on preventive or corrective action. - Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents, and terminate the mandate if the manufacturer acts contrary to its obligations, informing the competent authority and the notified body of the termination and its reasons. - Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device covered by your mandate. - Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation, and inform the competent authority of your Member State and, where applicable, the notified body of the termination and its reasons. - Have permanently and continuously at your disposal at least one person responsible for regulatory compliance with a relevant degree plus one year's experience or four years' experience in regulatory affairs or quality management for medical devices. - Expect joint and several liability with the manufacturer for defective devices where a non-EU manufacturer has not complied with Article 10, and define a change of authorised representative in a written agreement covering the dates, documents and the forwarding of complaints. - Where the non-EU manufacturer has not complied with its Article 10 obligations, you are legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. - On a change of authorised representative, define the change in an agreement between the manufacturer, the outgoing and the incoming representative covering the end and start dates of the mandates, the transfer of documents and the forwarding of complaints and incident reports. ### Importer - Place only conforming devices on the Union market and, before doing so, verify that the device is CE-marked and the EU declaration of conformity drawn up, that a manufacturer is identified and an authorised representative designated, that the device is labelled and accompanied by instructions for use as required, and that a UDI has been assigned where applicable; hold non-conforming devices back and inform the manufacturer and its representative, and the competent authority where the device presents a serious risk or is falsified. - Indicate your name, registered trade name or trade mark, registered place of business and contact address on the device, its packaging or an accompanying document without obscuring the manufacturer's label; if you relabel or repackage, follow the Article 16(2) to (4) conditions including a notified-body certificate for your quality management system and 28 days' notice to the manufacturer and the competent authority. - Indicate your name, registered trade name or registered trade mark, registered place of business and contact address on the device, its packaging or an accompanying document, without obscuring the manufacturer's label. - If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the relabelled or repackaged device available. - Verify that the device is registered in Eudamed, add your details to the registration, register yourself as an actor to obtain a single registration number, and within two weeks of placing a device on the market check that the manufacturer or authorised representative has entered the actor information. - Verify that the device is registered in Eudamed and add your details to the registration, and within two weeks of placing it on the market check that the manufacturer or authorised representative has entered the actor information. - Register as an actor in Eudamed to obtain a single registration number before placing devices on the market. - If you are established in Denmark, also notify Lægemiddelstyrelsen of your name, CVR number, contact details, role and the types of devices you import, and report changes and cessation; the national registration is separate from Eudamed and carries a one-off registration fee and an annual market-surveillance fee (bekendtgørelse nr. 1731 af 8. december 2025, § 14; bekendtgørelse nr. 1733 af 8. december 2025, §§ 2 and 3). - Keep storage and transport conditions from jeopardising compliance with Annex I and follow the manufacturer's conditions, and keep a register of complaints, non-conforming devices, recalls and withdrawals, sharing the information the manufacturer, authorised representative and distributors need to investigate complaints. - While a device is under your responsibility, keep storage and transport conditions from jeopardising its compliance with Annex I and follow the conditions set by the manufacturer. - Keep a register of complaints, non-conforming devices, recalls and withdrawals, and give the manufacturer, authorised representative and distributors the information they need to investigate complaints. - Where a device you placed on the market does not conform, immediately inform the manufacturer and its representative and cooperate on corrective action, withdrawal or recall; where it presents a serious risk also inform the competent authorities and the notified body; and forward complaints and suspected-incident reports from healthcare professionals, patients or users to the manufacturer and its representative immediately. - Where a device you placed on the market does not conform, immediately inform the manufacturer and its authorised representative and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, also inform the competent authorities and the notified body. - Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and its authorised representative. - Keep a copy of the EU declaration of conformity and any certificate for the Article 10(8) period, cooperate with competent authorities on risk-elimination measures, and provide free samples or access to the device on request. - Keep a copy of the EU declaration of conformity and any certificate for the Article 10(8) period: 10 years after the last device was placed on the market, and 15 years for implantable devices. - Cooperate with the competent authorities, at their request, on measures to eliminate or mitigate risks, and provide free samples of the device or, where impracticable, access to it. - If you market a device under your own name or trade mark, change its intended purpose or modify it in a way that may affect compliance, you assume the manufacturer's obligations, unless the manufacturer is identified on the label and contractually remains responsible. ### Distributor (wholesaler, pharmacy, retailer) - Act with due care and, before making a device available, verify (by representative sampling where allowed) that it is CE-marked with an EU declaration of conformity, accompanied by the manufacturer's label and instructions in the required language, that the importer has added its identification, and that a UDI has been assigned where applicable; hold non-conforming devices back, inform the manufacturer, its representative and the importer, and inform the competent authority where the device presents a serious risk or is falsified. - Keep storage and transport conditions in line with the manufacturer's conditions while the device is under your responsibility. - Where a device you made available does not conform, immediately inform the manufacturer, its representative and the importer and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, immediately inform the competent authorities of the Member States concerned. - Forward complaints and suspected-incident reports from healthcare professionals, patients or users to the manufacturer, its representative and the importer immediately, and keep a register of complaints, non-conforming devices, recalls and withdrawals. - Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and, where applicable, its authorised representative and the importer. - Keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep the manufacturer, authorised representative and importer informed of that monitoring. - On request, provide the competent authority with the information and documentation at your disposal demonstrating conformity, cooperate on risk-elimination measures and provide free samples or access to the device. - If you sell under your own name or trade mark, change the intended purpose or modify the device, you take on the manufacturer's obligations; if you translate the information or repackage the device, you need a quality management system certified by a notified body and must notify the manufacturer and the competent authority 28 days before making the relabelled or repackaged device available. - If you make a device available under your own name or trade mark, change its intended purpose or modify it in a way that may affect compliance, you take on the manufacturer's obligations. - If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the relabelled or repackaged device available. - Where national law requires it, register as a distributor: in Denmark, distributors and specialist retailers established in Denmark register with Lægemiddelstyrelsen, which stays a national registration outside Eudamed and carries a registration fee and an annual fee under bekendtgørelse nr. 1733 af 8. december 2025; shops that only sell devices at retail are exempt unless they are specialist retailers (bekendtgørelse nr. 1731 af 8. december 2025, § 14, stk. 6, and § 15). ## Requirements Each duty above as an identified requirement (64); ids are permanent and shared with the compliance engine. ### evidence - `mdr-mfr-design-to-annex-i` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Design and manufacture the device so that it meets the general safety and performance requirements of Annex I that apply to it, taking its intended purpose into account. [Art. 5(2) and Art. 10(1)] - `mdr-mfr-conduct-clinical-evaluation` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Conduct a clinical evaluation under Article 61 and Annex XIV, including post-market clinical follow-up; for implantable and class III devices run a clinical investigation unless an Article 61(4) to (6) exception applies, whose list of well-established devices Delegated Regulation (EU) 2026/1451 extended. [Art. 5(3), Art. 10(3) and Art. 61; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1451 · Art. 1] - `mdr-mfr-draw-technical-documentation` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Draw up and keep up to date the technical documentation of Annexes II and III, or the Annex XIII documentation for custom-made devices. [Art. 10(4) and (5)] - `mdr-mfr-draw-eu-declaration` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Draw up the EU declaration of conformity with the Annex IV content and the Basic UDI-DI, and keep it up to date. [Art. 10(6) and Art. 19] - `mdr-mfr-supply-label-ifu` (Manufacturer (including own-brand sellers and reprocessors), product-market, before-market) — Supply the label and instructions for use with the Annex I, Section 23 information in the official language(s) of the Member State where the device reaches the user or patient, with indelible and legible label particulars. [Art. 10(11)] - `mdr-mfr-supply-implant-card` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Provide an implant card and the Article 18 patient information with implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. [Art. 18] - `mdr-mfr-draw-sscp` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — For implantable and class III devices other than custom-made or investigational devices, draw up a summary of safety and clinical performance, validated by the notified body and published in Eudamed. [Art. 32] - `mdr-mfr-produce-pms-report-psur` (Manufacturer (including own-brand sellers and reprocessors), product, periodic) — Produce a post-market surveillance report for class I devices, or a periodic safety update report for class IIa (at least every two years) and classes IIb and III (at least annually), submitted through Eudamed to the notified body for class III and implantable devices. [Art. 85 and Art. 86] - `mdr-mfr-designate-authorised-representative` (Manufacturer (including own-brand sellers and reprocessors), company, before-market) — If you are established outside the Union, designate a sole authorised representative under a written mandate covering at least the Article 11(3) tasks, and keep the technical documentation permanently available to it. [Art. 10(8), third subparagraph, and Art. 11(1)] - `mdr-mfr-draw-procedure-pack-statement` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — If you combine CE-marked devices, or devices with other products, into a system or procedure pack, draw up the Article 22 statement and register the pack. [Art. 22] - `mdr-oth-accept-written-mandate` (Authorised representative, company, before-market) — Accept the written mandate, which is effective at least for all devices of the same generic device group, perform the tasks it specifies and provide a copy to the competent authority on request; the mandate cannot delegate the manufacturer's core duties in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). [Art. 11(2) to (4)] - `mdr-oth-forward-complaints-manufacturer` (Authorised representative, product, on-event) — Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device covered by your mandate. [Art. 11(3), point (g)] - `mdr-oth-agree-change-representative` (Authorised representative, company, on-event) — On a change of authorised representative, define the change in an agreement between the manufacturer, the outgoing and the incoming representative covering the end and start dates of the mandates, the transfer of documents and the forwarding of complaints and incident reports. [Art. 12] - `mdr-imp-forward-complaints` (Importer, product, on-event) — Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and its authorised representative. [Art. 13(8)] - `mdr-dist-forward-complaints` (Distributor (wholesaler, pharmacy, retailer), product, on-event) — Immediately forward complaints and reports of suspected incidents from healthcare professionals, patients or users to the manufacturer and, where applicable, its authorised representative and the importer. [Art. 14(5)] ### data - `mdr-mfr-assign-udi-carrier` (Manufacturer (including own-brand sellers and reprocessors), unit, before-market) — Assign a UDI (UDI-DI and UDI-PI) from a designated issuing entity to each device other than custom-made and investigational devices and to higher packaging levels, place the UDI carrier on the label and packaging by the Article 123(3) dates, and keep the list of UDIs in the technical documentation. [Art. 27(1), (3), (4) and (7) and Art. 123(3), points (f) and (g)] ### mark - `mdr-mfr-affix-ce-marking` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Affix the CE marking to the device, followed by the identification number of the notified body where a notified body was involved in the conformity assessment. [Art. 10(6) and Art. 20] - `mdr-imp-indicate-name-address` (Importer, product, before-market) — Indicate your name, registered trade name or registered trade mark, registered place of business and contact address on the device, its packaging or an accompanying document, without obscuring the manufacturer's label. [Art. 13(3)] ### decision - `mdr-mfr-classify-device` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Classify the device into class I, IIa, IIb or III using the 22 classification rules of Annex VIII. [Art. 51(1) and Annex VIII] ### procedure - `mdr-mfr-run-risk-management` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Establish, document, implement and maintain a risk management system for the device, as a continuous process throughout its lifecycle. [Art. 10(2)] - `mdr-mfr-run-conformity-assessment` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Before placing the device on the market, run the conformity assessment procedure of Article 52 for its class: a notified body under Annex IX, X or XI for classes IIa, IIb and III, and self-declaration for class I, with a notified body for sterile, measuring and reusable surgical aspects. [Art. 52(1) to (7); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1359 · Art. 1] - `mdr-mfr-run-pms-system` (Manufacturer (including own-brand sellers and reprocessors), product, ongoing) — Plan, run and keep up to date a post-market surveillance system proportionate to the risk class, based on a post-market surveillance plan that is part of the technical documentation. [Art. 10(10), Art. 83 and Art. 84] - `mdr-imp-relabel-repackage-conditions` (Importer, product, before-market) — If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the relabelled or repackaged device available. [Art. 16(2) to (4)] - `mdr-dist-relabel-repackage-conditions` (Distributor (wholesaler, pharmacy, retailer), product, before-market) — If you translate the manufacturer's information or repackage the device, meet the Article 16(2) to (4) conditions: a quality management system certified by a notified body for those activities, and 28 days' notice to the manufacturer and the competent authority before making the relabelled or repackaged device available. [Art. 16(2) to (4)] ### submission - `mdr-mfr-submit-udi-database` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Assign a Basic UDI-DI and submit the Annex VI core data to the UDI database before placing the device on the market. [Art. 29(1)] - `mdr-mfr-register-actor-srn` (Manufacturer (including own-brand sellers and reprocessors), company, before-market) — Register as an actor in Eudamed to obtain a single registration number before placing a device on the market and before applying to a notified body. [Art. 31; https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1] - `mdr-mfr-confirm-actor-data` (Manufacturer (including own-brand sellers and reprocessors), company, periodic) — Update your Eudamed actor data within one week of any change, and confirm its accuracy one year after registration and every second year thereafter. [Art. 31; https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1] - `mdr-mfr-register-devices-eudamed` (Manufacturer (including own-brand sellers and reprocessors), product, before-market) — Register each device in Eudamed: the registration modules are mandatory from 28 May 2026, and devices placed on the market from that date must be entered no later than 28 November 2026. [Art. 29(4) and Art. 123(3), points (d) and (e); https://health.ec.europa.eu/medical-devices-eudamed/overview_en; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371 · Art. 1] - `mdr-mfr-report-serious-incident` (Manufacturer (including own-brand sellers and reprocessors), product, on-event) — Report each serious incident to the competent authority immediately and no later than 15 days after becoming aware, 2 days for a serious public health threat and 10 days for a death or unanticipated serious deterioration in health; investigate it and provide a final report. [Art. 10(13), Art. 87(1)(a) and (3) to (5) and Art. 89] - `mdr-mfr-report-field-safety-action` (Manufacturer (including own-brand sellers and reprocessors), product, on-event) — Report each field safety corrective action to the competent authorities before undertaking it, except in urgent cases, and bring it to the users' attention without delay through a field safety notice. [Art. 87(1)(b) and Art. 89(8)] - `mdr-mfr-submit-trend-reports` (Manufacturer (including own-brand sellers and reprocessors), product, on-event) — Report any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or in expected undesirable side-effects, that could significantly affect the benefit-risk analysis. [Art. 88] - `mdr-mfr-take-corrective-action` (Manufacturer (including own-brand sellers and reprocessors), product, on-event) — Where a device you placed on the market does not conform, immediately take corrective action, withdraw or recall it, inform distributors, the authorised representative and importers, and where it presents a serious risk inform the competent authorities and the notified body. [Art. 10(12)] - `mdr-mfr-give-competent-authority` (Manufacturer (including own-brand sellers and reprocessors), product, on-event) — Give the competent authority of your or your authorised representative's Member State and your direct customers, health institutions and healthcare professionals at least 6 months' notice of an anticipated interruption or discontinuation of supply of a device, other than a custom-made device, that could foreseeably cause serious harm to patients or public health, stating the reasons; the duty applies since 10 January 2025 and covers legacy devices. [Art. 10a and Art. 120(13); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860 · Art. 3] - `mdr-oth-register-actor-srn` (Authorised representative, company, before-market) — Register in Eudamed to obtain your own single registration number, and keep your actor data updated and confirmed. [Art. 31] - `mdr-oth-terminate-mandate-breach` (Authorised representative, company, on-event) — Terminate the mandate if the manufacturer acts contrary to its obligations under this regulation, and inform the competent authority of your Member State and, where applicable, the notified body of the termination and its reasons. [Art. 11(3), point (h), and Art. 11(6)] - `mdr-imp-register-actor-srn` (Importer, company, before-market) — Register as an actor in Eudamed to obtain a single registration number before placing devices on the market. [Art. 31] - `mdr-imp-notify-gemiddelstyrelsen-name` (Importer, company, before-market) — If you are established in Denmark, also notify Lægemiddelstyrelsen of your name, CVR number, contact details, role and the types of devices you import, and report changes and cessation; the national registration is separate from Eudamed and carries a one-off registration fee and an annual market-surveillance fee (bekendtgørelse nr. 1731 af 8. december 2025, § 14; bekendtgørelse nr. 1733 af 8. december 2025, §§ 2 and 3). [§ 14; https://www.retsinformation.dk/eli/lta/2025/1733 · §§ 2–3] - `mdr-imp-inform-nonconformity` (Importer, product, on-event) — Where a device you placed on the market does not conform, immediately inform the manufacturer and its authorised representative and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, also inform the competent authorities and the notified body. [Art. 13(7)] - `mdr-dist-immediately-inform-manufacturer` (Distributor (wholesaler, pharmacy, retailer), product, on-event) — Where a device you made available does not conform, immediately inform the manufacturer, its representative and the importer and cooperate on corrective action, withdrawal or recall; where it presents a serious risk, immediately inform the competent authorities of the Member States concerned. [Art. 14(4)] - `mdr-dist-register-distributor-denmark` (Distributor (wholesaler, pharmacy, retailer), company, before-market) — Where national law requires it, register as a distributor: in Denmark, distributors and specialist retailers established in Denmark register with Lægemiddelstyrelsen, which stays a national registration outside Eudamed and carries a registration fee and an annual fee under bekendtgørelse nr. 1733 af 8. december 2025; shops that only sell devices at retail are exempt unless they are specialist retailers (bekendtgørelse nr. 1731 af 8. december 2025, § 14, stk. 6, and § 15). [Art. 30(2); https://www.retsinformation.dk/eli/lta/2025/1731 · § 14 and § 15; https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-af-distributoer-og-specialforretning/; https://laegemiddelstyrelsen.dk/da/udstyr/gebyrer/] ### verification - `mdr-oth-verify-declaration-documentation` (Authorised representative, product, ongoing) — Verify that the EU declaration of conformity and the technical documentation have been drawn up and that the manufacturer has carried out the applicable conformity assessment procedure. [Art. 11(3), point (a)] - `mdr-oth-verify-manufacturer-registration` (Authorised representative, product, before-market) — Verify that the manufacturer has complied with its UDI and registration obligations for the device and for itself. [Art. 11(3), point (c)] - `mdr-imp-place-conforming-devices` (Importer, product, before-market) — Place only conforming devices on the Union market and, before doing so, verify that the device is CE-marked and the EU declaration of conformity drawn up, that a manufacturer is identified and an authorised representative designated, that the device is labelled and accompanied by instructions for use as required, and that a UDI has been assigned where applicable; hold non-conforming devices back and inform the manufacturer and its representative, and the competent authority where the device presents a serious risk or is falsified. [Art. 13(1) and (2)] - `mdr-imp-verify-device-registration` (Importer, product, before-market) — Verify that the device is registered in Eudamed and add your details to the registration, and within two weeks of placing it on the market check that the manufacturer or authorised representative has entered the actor information. [Art. 13(4) and Art. 30(3)] - `mdr-dist-act-due-care` (Distributor (wholesaler, pharmacy, retailer), product, before-market) — Act with due care and, before making a device available, verify (by representative sampling where allowed) that it is CE-marked with an EU declaration of conformity, accompanied by the manufacturer's label and instructions in the required language, that the importer has added its identification, and that a UDI has been assigned where applicable; hold non-conforming devices back, inform the manufacturer, its representative and the importer, and inform the competent authority where the device presents a serious risk or is falsified. [Art. 14(1) and (2)] ### standing - `mdr-mfr-keep-documentation-years` (Manufacturer (including own-brand sellers and reprocessors), product, ongoing) — Keep the technical documentation, the EU declaration of conformity and any certificates available to the competent authorities for at least 10 years after the last device covered by the declaration was placed on the market, and 15 years for implantable devices. [Art. 10(8)] - `mdr-mfr-operate-qms` (Manufacturer (including own-brand sellers and reprocessors), company, ongoing) — Operate and keep up to date a quality management system, proportionate to the risk class and type of device, that covers the elements of Article 10(9) and keeps series production in conformity. [Art. 10(9)] - `mdr-mfr-appoint-prrc` (Manufacturer (including own-brand sellers and reprocessors), company, ongoing) — Have within your organisation at least one person responsible for regulatory compliance with the Article 15 qualifications or, as a micro or small enterprise, have such a person permanently and continuously at your disposal. [Art. 15(1) to (3)] - `mdr-mfr-provide-information-request` (Manufacturer (including own-brand sellers and reprocessors), company, ongoing) — On a competent authority's request, provide all information and documentation demonstrating conformity in the language the Member State determines, provide samples or access to the device, and cooperate on measures to eliminate or mitigate risks. [Art. 10(14)] - `mdr-mfr-hold-liability-coverage` (Manufacturer (including own-brand sellers and reprocessors), company, ongoing) — Have measures in place to provide sufficient financial coverage for your potential liability for defective devices, proportionate to the risk class, type of device and size of the enterprise. [Art. 10(16)] - `mdr-mfr-avoid-misleading-claims` (Manufacturer (including own-brand sellers and reprocessors), company, ongoing) — Do not use text, names, trademarks, pictures or signs in labelling, instructions, making available or advertising that mislead the user or patient on the device's intended purpose, safety or performance. [Art. 7] - `mdr-oth-keep-documentation-copy` (Authorised representative, product, ongoing) — Keep a copy of the technical documentation, the EU declaration of conformity and any certificate at the disposal of the competent authorities for 10 years after the last device was placed on the market, and 15 years for implantable devices. [Art. 11(3), point (b), and Art. 10(8)] - `mdr-oth-provide-competent-authority` (Authorised representative, company, ongoing) — On request, provide the competent authority with all information and documentation demonstrating conformity in the language it determines, forward requests for samples or access to the manufacturer and verify that the authority receives them, and cooperate on preventive or corrective action. [Art. 11(3), points (d) to (f)] - `mdr-oth-have-permanently-continuously` (Authorised representative, company, ongoing) — Have permanently and continuously at your disposal at least one person responsible for regulatory compliance with a relevant degree plus one year's experience or four years' experience in regulatory affairs or quality management for medical devices. [Art. 15(6)] - `mdr-imp-ensure-storage-transport` (Importer, company, ongoing) — While a device is under your responsibility, keep storage and transport conditions from jeopardising its compliance with Annex I and follow the conditions set by the manufacturer. [Art. 13(5)] - `mdr-imp-keep-complaints-register` (Importer, company, ongoing) — Keep a register of complaints, non-conforming devices, recalls and withdrawals, and give the manufacturer, authorised representative and distributors the information they need to investigate complaints. [Art. 13(6)] - `mdr-imp-keep-declaration-copy` (Importer, product, ongoing) — Keep a copy of the EU declaration of conformity and any certificate for the Article 10(8) period: 10 years after the last device was placed on the market, and 15 years for implantable devices. [Art. 13(9)] - `mdr-imp-cooperate-provide-samples` (Importer, company, ongoing) — Cooperate with the competent authorities, at their request, on measures to eliminate or mitigate risks, and provide free samples of the device or, where impracticable, access to it. [Art. 13(10)] - `mdr-dist-keep-storage-transport` (Distributor (wholesaler, pharmacy, retailer), company, ongoing) — Keep storage and transport conditions in line with the manufacturer's conditions while the device is under your responsibility. [Art. 14(3)] - `mdr-dist-keep-complaints-register` (Distributor (wholesaler, pharmacy, retailer), company, ongoing) — Keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep the manufacturer, authorised representative and importer informed of that monitoring. [Art. 14(5)] - `mdr-dist-provide-competent-authority` (Distributor (wholesaler, pharmacy, retailer), company, ongoing) — On request, provide the competent authority with the information and documentation at your disposal demonstrating conformity, cooperate on risk-elimination measures and provide free samples or access to the device. [Art. 14(6)] ## Penalties Member States lay down the rules on penalties for infringements of the regulation and take all measures necessary to ensure that they are implemented; the penalties must be effective, proportionate and dissuasive and were notified to the Commission by 25 February 2021. Competent authorities check devices through documentation reviews, physical or laboratory checks and announced or unannounced inspections of economic operators, suppliers and subcontractors, may require documentation, information and free samples, and may confiscate, destroy or render inoperable devices that present an unacceptable risk or are falsified. Where a device presents an unacceptable risk they require corrective action, restriction, specific conditions, withdrawal or recall within a set period and, if the operator fails to act, prohibit or restrict the making available, withdraw or recall the device and notify the Commission and the other Member States through Eudamed; other non-compliance must be ended within a set period, otherwise the same measures follow; a Member State may also take preventive health-protection measures against a category of devices. A manufacturer that fails to cooperate or provides incomplete information can see its device prohibited, restricted, withdrawn or recalled until it complies. In Denmark, Lægemiddelstyrelsen (the Danish Medicines Agency) supervises manufacturers and the other operators and applies the Danish act on medical devices (lovbekendtgørelse nr. 682 af 29. maj 2023, as amended by lov nr. 1759 af 29. december 2025), whose § 3 names Lægemiddelstyrelsen as the competent authority, bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (in force 1 January 2026) and the fee orders bekendtgørelse nr. 839 af 20. juni 2023 (as amended) and bekendtgørelse nr. 1733 af 8. december 2025. Breaches of the MDR and of orders, prohibitions or information duties under it are punishable in Denmark by a fine or imprisonment of up to one year and six months (§ 6(2) of the act on medical devices), with liability for companies (§ 6(4)); failure to make the national notifications of §§ 12 to 15 of bekendtgørelse nr. 1731 is punishable by a fine (§ 20). ## Checklist 1. Confirm the product has an intended medical purpose under Article 2(1) or is an Annex XVI product, and that no Article 1(6) exclusion (IVD, medicinal product, cosmetic, tissues, food) applies; check borderline combinations against the principal mode of action (Article 1(8) and (9)). 2. Decide your role for each device: manufacturer, authorised representative, importer or distributor, remembering that own-brand sales, changing the intended purpose, modifying or reprocessing a device make you the manufacturer (Articles 16 and 17). 3. Classify the device with the 22 rules of Annex VIII, including the software rule 11 and the implant rule 8, and record the rationale; the class sets the conformity route, the PSUR cycle and the UDI dates. 4. Choose and book the conformity assessment: notified body under Annex IX, X or XI for classes IIa, IIb and III and for sterile, measuring or reusable surgical class I devices; the EU declaration of conformity alone for other class I devices (Article 52). 5. Build the technical documentation of Annexes II and III with the risk management file, the clinical evaluation plan and report with PMCF, the label and instructions in the Member State languages, and the post-market surveillance plan (Articles 10(4), 61, 83 and 84). 6. Set up the quality management system of Article 10(9) and name the person responsible for regulatory compliance (Article 15); micro and small enterprises may contract the person externally. 7. Register as an actor in Eudamed to get your single registration number, assign the Basic UDI-DI and UDIs, place the UDI carrier on labels and packaging, and register each device in Eudamed by 28 November 2026 for devices placed on the market from 28 May 2026 (Articles 27, 29, 31 and 123(3)). 8. Draw up the EU declaration of conformity with the Annex IV content, affix the CE marking with the notified body number, and for implantable and class III devices prepare the implant card and the summary of safety and clinical performance (Articles 18, 19, 20 and 32). 9. Run vigilance: a procedure that reports serious incidents within 15, 10 or 2 days, field safety corrective actions and notices, trend reports, and a supply-interruption notice at least 6 months ahead (Articles 10a and 87 to 89). 10. For legacy devices, map every directive certificate against 31 December 2027 or 31 December 2028, evidence the Article 120(3c) conditions (QMS by 26 May 2024, notified-body application by 26 May 2024, written agreement by 26 September 2024) and apply the MDR post-market, vigilance and registration rules already now (Article 120(3a) to (3d)). ## Questions ### When did the MDR start to apply? Regulation (EU) 2017/745 was adopted on 5 April 2017, published on 5 May 2017 and entered into force on 25 May 2017. It applies since 26 May 2021, one year later than originally planned because Regulation (EU) 2020/561 postponed the date of application during the COVID-19 pandemic. The chapters on notified bodies and the Medical Device Coordination Group applied from 26 November 2017 so that bodies could be designated in time, and on 26 May 2021 Directives 90/385/EEC and 93/42/EEC were repealed, subject to the transitional provisions of Article 120. ### Until when can legacy devices with a directive certificate still be placed on the market? Regulation (EU) 2023/607 extended the transition by risk class. Devices with a certificate issued under Directive 90/385/EEC or 93/42/EEC that was still valid on 26 May 2021 may be placed on the market or put into service until 31 December 2027 for class III devices and class IIb implantable devices (other than sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), and until 31 December 2028 for the other class IIb devices, class IIa devices and class I devices that are sterile or have a measuring function; class I devices whose declaration of conformity was drawn up before 26 May 2021 and that now need a notified body also have until 31 December 2028. The conditions are continued compliance with the directive, no significant change in design or intended purpose, no unacceptable risk, a quality management system by 26 May 2024, a notified-body application by 26 May 2024 and a signed written agreement by 26 September 2024; the MDR rules on post-market surveillance, vigilance, market surveillance and registration already apply to these devices, and devices lawfully placed on the market may continue to be made available without a sell-off deadline. ### Is my software or app a medical device, and in which class? Software is a medical device when the manufacturer intends it for a medical purpose listed in Article 2(1), such as diagnosis, prediction, monitoring or treatment of disease, and it is then an active device. Software that drives or influences another device takes that device's class; independent software is classified in its own right under rule 11 of Annex VIII: software providing information used for diagnostic or therapeutic decisions is class IIa, class IIb where such decisions may cause a serious deterioration in health or a surgical intervention, and class III where they may cause death or an irreversible deterioration; software monitoring physiological processes is class IIa, or IIb for vital parameters whose variation could put the patient in immediate danger; all other software is class I. The Commission's MDCG 2019-11 guidance on qualification and classification of software supports the assessment. ### When does Eudamed become mandatory? Regulation (EU) 2024/1860 lets Eudamed roll out module by module: the obligations linked to a module apply 6 months after the Commission publishes the notice that it is functional. Commission Decision (EU) 2025/2371, published on 27 November 2025, confirmed the four modules for actor registration, UDI and device registration, notified bodies and certificates, and market surveillance, so their use is mandatory from 28 May 2026, when manufacturers, authorised representatives, importers and producers of systems and procedure packs register in Eudamed instead of national databases. Devices placed on the market from that date must be entered no later than 12 months after the notice, and notified bodies must enter their certificates no later than 18 months after it; the vigilance and clinical-investigation modules are still under development and will become mandatory only after their own notice. ### Do I need a notified body for a class I device? Not for a basic class I device: the manufacturer draws up the Annex II and III technical documentation and issues the EU declaration of conformity itself. A notified body is needed if the class I device is placed on the market in sterile condition, has a measuring function or is a reusable surgical instrument, but only for the sterility, metrology or reuse aspects respectively, under Annex IX Chapters I and III or Annex XI Part A. Every device above class I needs a notified body, and class III custom-made implantables need one since 26 May 2026. ### How quickly must serious incidents be reported? The manufacturer reports every serious incident involving a device on the Union market immediately after establishing a causal relationship, or that one is reasonably possible, and no later than 15 days after becoming aware of it; no later than 2 days for a serious public health threat and no later than 10 days for a death or an unanticipated serious deterioration in health. Field safety corrective actions are reported in advance except in urgent cases, an incomplete initial report may be followed by a complete one, and a report is due even when the manufacturer is unsure whether the incident is reportable. Users and patients are encouraged to report to the competent authority, in Denmark Lægemiddelstyrelsen, which then informs the manufacturer. ### Do products without a medical purpose, such as dermal fillers or IPL hair-removal equipment, fall under the MDR? Yes, if they belong to one of the six groups in Annex XVI: contact lenses and other items placed in or on the eye; surgically invasive products that modify the anatomy or fix body parts (other than tattoos and piercings); dermal and mucous-membrane fillers; equipment to reduce, remove or destroy fat tissue such as liposuction and lipolysis; high-intensity electromagnetic equipment such as lasers and intense pulsed light for skin resurfacing, tattoo or hair removal; and brain-stimulation equipment. The regulation applies to them from the date of application of the common specifications adopted under Article 9, which their manufacturers must comply with, and a product with both a medical and a non-medical purpose must meet both sets of requirements. ### What must an importer or distributor in Denmark do beyond the EU rules? Importers verify the CE marking, declaration, labelling, authorised representative and UDI before placing a device on the market, add their own identification, register in Eudamed and add their details to the device registration. Distributors verify the same points before making the device available and forward complaints and incident reports. In Denmark, manufacturers, authorised representatives and importers register in Eudamed from 28 May 2026, with Lægemiddelstyrelsen verifying the company data within up to 14 days before Eudamed issues the single registration number; in addition, importers and distributors established in Denmark (and specialist retailers) must notify Lægemiddelstyrelsen under §§ 14 and 15 of bekendtgørelse nr. 1731 af 8. december 2025 and pay a registration fee and an annual fee under bekendtgørelse nr. 1733; that national registration is separate from Eudamed, and shops that only sell devices at retail are exempt unless they are specialist retailers. ## What changed - 2028-12-31 (applies): **Transitional period ends for the remaining legacy devices** — Last day on which legacy class IIb devices not covered by the 2027 deadline, class IIa devices, class I devices placed on the market sterile or with a measuring function, and class I devices up-classified by the regulation may be placed on the market or put into service under a directive certificate or declaration; devices already placed on the market may continue to be made available. - 2028-11-01 (applies): **Master UDI-DI applies to spectacle frames, lenses and reading spectacles** — Delegated Regulation (EU) 2025/1920 applies: spectacle frames, spectacle lenses and ready-to-wear reading spectacles with the same combination of design parameters share one Master UDI-DI under Annex VI, Part C, Section 6.6.2. - 2027-12-31 (applies): **Transitional period ends for class III and class IIb implantable legacy devices** — Last day on which legacy class III devices and class IIb implantable devices, other than sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, may be placed on the market or put into service under a directive certificate. - 2027-05-28 (applies): **Notified-body certificates must be in Eudamed** — Eighteen months after the Eudamed notice of 27 November 2025, notified bodies must have entered the Article 56(5) certificate information in Eudamed, including the latest certificate for devices already on the market; the summary of safety and clinical performance and certificate notifications follow the certificate entry. - 2027-05-26 (applies): **UDI carrier directly on reusable class I devices** — Reusable class I devices that must bear the UDI carrier on the device itself must carry it from this date, the last step of the direct-marking schedule reset by Regulation (EU) 2020/561. - 2026-11-28 (applies): **Device registration backlog must be entered in Eudamed** — Twelve months after the Eudamed notice, manufacturers must have entered the Article 29 information for devices placed on the market from 28 May 2026, including legacy devices placed on the market under Article 120(3), (3a) or (3b) unless already registered. - 2026-09-11 (guidance): **Guide rebuilt from the consolidated text of 19 July 2026** — The body was rewritten from the consolidated text and the ten amending acts: the earlier version stated that only devices above class I need a notified body and that every device must carry a UDI; it now states that sterile, measuring and reusable surgical class I devices also involve a notified body and that custom-made and investigational devices carry no UDI, and adds the exact Article 120 transition dates, the Eudamed timeline after Decision (EU) 2025/2371, Article 10a, the 2026 delegated acts and the Danish registration rules. The Commission's proposal COM(2025) 1023 of 16 December 2025 to simplify the MDR and IVDR is a proposal under the ordinary legislative procedure, not law, and is mentioned as such. - 2026-07-19 (amendment): **Delegated Regulation (EU) 2026/1451 in force: more well-established devices exempt from clinical investigations** — Article 61(6), point (b), now lists a longer set of implantable and class III device types, from sutures, screws and plates to catheters, guidewires, pacing wires and leads, embolisation coils, shunts and reusable surgical instruments, for which no clinical investigation is required where the clinical evaluation rests on sufficient clinical data and any product-specific common specification; the clinical evaluation obligation remains. - 2026-07-19 (amendment): **Delegated Regulation (EU) 2026/1359 in force: longer list of class IIb implantables assessed on a representative basis** — The second subparagraph of Article 52(4) now exempts a second group of well-established class IIb implantable devices, including cannulas, catheters, feeding tubes, bone wax, bone fillers and substitutes, nails, anchors, spinal posterior fixations, dental implants and orthodontic devices, from the assessment of the technical documentation for every device. - 2026-05-28 (applies): **Eudamed mandatory for actors, devices, certificates and market surveillance** — Six months after Commission Decision (EU) 2025/2371, the obligations linked to the first four Eudamed modules apply: manufacturers, authorised representatives, importers and producers of systems and procedure packs register in Eudamed and obtain their single registration number there, devices are registered with their Basic UDI-DI and UDI data, and the corresponding directive-based national registration rules are repealed; in Denmark, Lægemiddelstyrelsen verifies the actor data and continues to register distributors nationally. - 2026-05-26 (applies): **Class III custom-made implantable devices need a notified-body certificate** — The derogation of Article 120(3f) ends: class III custom-made implantable devices may no longer be placed on the market without the Annex IX Chapter I or Annex XI Part A assessment by a notified body. - 2026-01-01 (amendment): **Regulation (EU) 2025/2457 in force: endocrine disruptors and ECHA guidelines in Annex I** — Annex I, Section 10.4.1, point (b), now covers Category 1 endocrine disruptors for human health under the CLP Regulation alongside substances identified under REACH and the Biocidal Products Regulation, and Sections 10.4.3 and 10.4.4 task the European Chemicals Agency, at the Commission's request and at least every 5 years, with the guidelines on phthalates and other CMR or endocrine-disrupting substances in devices. - 2025-11-27 (applies): **Commission Decision (EU) 2025/2371 published: Eudamed clock starts** — The Commission confirmed in the Official Journal that the Eudamed systems for registration of economic operators, the UDI database and device registration, notified bodies and certificates, and market surveillance are functional and meet the functional specifications, starting the 6-, 12- and 18-month periods of Article 123(3), points (d), (e) and (ea). - 2025-11-09 (applies): **Master UDI-DI applies to contact lenses** — Delegated Regulation (EU) 2023/2197 applies: standard and made-to-order contact lenses with the same combination of design parameters, including at least base curve and diameter, share one Master UDI-DI under Annex VI, Part C, Section 6.6.1. - 2025-10-13 (amendment): **Delegated Regulation (EU) 2025/1920 in force: Master UDI-DI for spectacles** — Adopted on 12 June 2025 and published on 23 September 2025, the delegated regulation adds Section 6.6.2 to Annex VI, Part C, for spectacle frames, spectacle lenses and ready-to-wear reading spectacles; it applies from 1 November 2028, with earlier voluntary use allowed. - 2025-05-26 (applies): **UDI carrier on class I labels and directly on reusable class IIa and IIb devices** — From this date the UDI carrier must appear on the labels and packaging of class I devices, and reusable class IIa and IIb devices that must bear the carrier on the device itself must carry it. - 2025-01-10 (applies): **Supply-interruption notice under Article 10a applies** — Manufacturers must inform the competent authority of the Member State where they or their authorised representative are established, and the operators, health institutions and healthcare professionals they supply directly, at least 6 months before an anticipated interruption or discontinuation of supply that could cause serious harm; operators pass the information down the chain, and the duty also covers legacy devices. - 2024-09-26 (applies): **Written agreement with a notified body required for legacy devices** — Legacy devices may stay on the market beyond this date only if the notified body and the manufacturer have signed the written agreement under Section 4.3 of Annex VII; from this date that notified body is responsible for the surveillance of the devices covered. - 2024-07-09 (amendment): **Regulation (EU) 2024/1860 in force: gradual Eudamed roll-out and supply-interruption notice** — The regulation of 13 June 2024 inserts Article 10a, applicable from 10 January 2025, lets each Eudamed module become mandatory 6 months after its own functionality notice, sets 12- and 18-month deadlines for entering existing devices and certificates, adapts the coordinated assessment of clinical investigations, deletes Article 120(8) and aligns the repeal of the directives' registration and vigilance provisions with the module dates. - 2024-05-26 (applies): **Quality management system and notified-body application required for legacy devices** — To benefit from the extended transition, manufacturers had to have a quality management system under Article 10(9) in place and a formal application for conformity assessment lodged with a notified body by this date; class III custom-made implantables had to apply by the same date. - 2024-02-15 (amendment): **Regulation (EU) 2024/568 in force: EMA fees for expert-panel advice** — The EMA fees regulation of 7 February 2024 replaces Article 106(14) so that the European Medicines Agency can levy the fees for expert-panel advice set by the Commission; it applies from 1 January 2025. - 2023-11-09 (amendment): **Delegated Regulation (EU) 2023/2197 in force: Master UDI-DI for contact lenses** — Adopted on 10 July 2023 and published on 20 October 2023, the delegated regulation adds Section 6.6 on highly individualised devices to Annex VI, Part C, applicable from 9 November 2025. - 2023-05-26 (applies): **UDI carrier on class IIa and IIb labels and directly on reusable implantable and class III devices** — From this date the UDI carrier must appear on the labels and packaging of class IIa and IIb devices, and reusable implantable and class III devices that must bear the carrier on the device itself must carry it. - 2023-03-20 (amendment): **Regulation (EU) 2023/607 in force: transition extended to 2027 and 2028** — Published and in force on 20 March 2023, the regulation extends the validity of directive certificates and the placing on the market of legacy devices to 31 December 2027 for class III and class IIb implantables and to 31 December 2028 for the other classes, subject to the Article 120(3c) conditions, gives class III custom-made implantables until 26 May 2026 and removes the sell-off deadline of Article 120(4). - 2023-03-11 (amendment): **Delegated Regulation (EU) 2023/502 in force: notified-body re-assessment every 5 years** — Article 44(10) now provides for a complete re-assessment of each notified body 5 years after notification and every 5 years thereafter, so that authorities and notified bodies can focus on certification during the transitional period. - 2022-05-27 (applies): **Directive EC-verification certificates become void** — Certificates issued under Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC lost their validity at the latest on this date, while other directive certificates issued before 25 May 2017 remained valid until their expiry. - 2021-05-26 (applies): **MDR applies; Directives 90/385/EEC and 93/42/EEC repealed** — The regulation applies in full from this date, notifications of notified bodies under the directives become void, the directives are repealed subject to the transitional provisions and the directive-based registration and vigilance provisions that survive until the Eudamed modules apply, and the UDI carrier must appear on the labels of implantable and class III devices. - 2020-04-24 (amendment): **Regulation (EU) 2020/561 in force: application postponed to 26 May 2021** — Adopted on 23 April 2020 and in force on the day of publication, the regulation defers the date of application and the linked deadlines by one year because of the COVID-19 pandemic and makes the Article 59 derogation procedure applicable immediately so that national derogations can be extended to the whole Union. - 2017-11-26 (applies): **Notified-body and MDCG provisions apply** — Articles 35 to 50 on the designation and oversight of notified bodies and Articles 101 and 103 on the Medical Device Coordination Group apply from this date, ahead of the general date of application. - 2017-05-25 (in-force): **Regulation (EU) 2017/745 enters into force** — Adopted on 5 April 2017 and published in OJ L 117 on 5 May 2017, the regulation entered into force on the twentieth day after publication, with a three-year transition to the original date of application of 26 May 2020. ## MDR in plain terms The Medical Devices Regulation (MDR), formally Regulation (EU) 2017/745, is the EU's single rulebook for placing medical devices for human use and their accessories on the market, making them available and putting them into service (Art. 1(1)). It replaced the Active Implantable Medical Devices Directive 90/385/EEC and the Medical Devices Directive 93/42/EEC on 26 May 2021 (Art. 122 and Art. 123(2)) and, as a regulation, applies directly in every Member State without national transposition. Its architecture is the classic CE-marking model, tightened for the medical field: general safety and performance requirements in Annex I, a clinical evaluation for every device, risk classification into classes I, IIa, IIb and III, a conformity assessment by a notified body for everything above basic class I, the EU declaration of conformity and CE marking, and then a lifetime of post-market surveillance, vigilance and traceability through the Unique Device Identifier and the European database Eudamed. The regulation entered into force on 25 May 2017. Its date of application was moved from 26 May 2020 to 26 May 2021 by Regulation (EU) 2020/561 during the COVID-19 pandemic, and Regulation (EU) 2023/607 later gave legacy devices with directive certificates until 31 December 2027 or 31 December 2028, depending on risk class, to complete their MDR certification (Art. 120(3a)). Regulation (EU) 2024/1860 let Eudamed go live module by module; after Commission Decision (EU) 2025/2371 the first four modules are mandatory from 28 May 2026. > **Official text** > Read the regulation on EUR-Lex: [Regulation (EU) 2017/745 (CELEX 32017R0745)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745), or the [consolidated text of 19 July 2026](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719) that includes the postponement, the extended transitional provisions, the Eudamed roll-out, Article 10a, the 2025 amendment to Annex I and the 2026 delegated acts on well-established devices (the Master UDI-DI sections added by Delegated Regulations (EU) 2023/2197 and 2025/1920 are not yet consolidated and are read from those acts). ## Scope A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article that the manufacturer intends for one or more specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by in vitro examination of specimens, provided the principal intended action is not pharmacological, immunological or metabolic (Art. 2(1), point (1)). Devices for the control or support of conception and products for cleaning, disinfecting or sterilising devices are deemed medical devices, and accessories are covered in their own right (Art. 2(1), points (1) and (2)). Software is an active device (Art. 2(1), point (4)). The regulation also reaches the six groups of products without a medical purpose in Annex XVI, from contact lenses and dermal fillers to liposuction equipment, IPL and laser skin devices and brain-stimulation equipment, from the date of application of their common specifications (Art. 1(2) and Annex XVI). It applies to devices offered online to persons in the Union and to devices used for diagnostic or therapeutic services provided at a distance (Art. 6). Article 1(6) lists what is excluded: in vitro diagnostic medical devices, which fall under Regulation (EU) 2017/746; medicinal products and advanced therapy medicinal products; human blood and blood products; cosmetics; transplants, tissues or cells of animal or human origin; products containing viable biological material; and food. Borderline cases are decided by the principal mode of action, and a device with an ancillary medicinal substance is assessed under the MDR while a non-reusable single integral drug-device combination follows the medicinal products rules (Art. 1(8) and (9)). Devices made and used only within a health institution are exempt from everything except the relevant Annex I requirements, provided the eight conditions of Article 5(5) are met and manufacture is not on an industrial scale. The duties fall on the economic operators: the manufacturer, the authorised representative, the importer, the distributor and the person who puts systems or procedure packs together (Art. 2(1), points (30) to (35)). A distributor, importer or other person that sells a device under its own name or trade mark, changes its intended purpose or modifies it in a way that may affect compliance assumes the manufacturer's obligations (Art. 16), as does anyone who reprocesses a single-use device (Art. 17(2)). A manufacturer established outside the Union may place devices on the market only through a sole authorised representative (Art. 11(1)). ## What you must do ### Classification and conformity assessment Devices are divided into classes I, IIa, IIb and III according to their intended purpose and inherent risks, using the 22 rules of Annex VIII (Art. 51(1)). Duration of use, invasiveness, whether the device is active, and contact with the heart, the central circulatory system or the central nervous system drive the outcome; rule 8 makes implantable and long-term surgically invasive devices class IIb by default and class III where they touch the heart or central nervous system, are absorbed, administer medicinal products, are active implantables, breast implants, surgical meshes, joint replacements or spinal implants; rule 11 classifies software by the consequences of the decisions it informs (Annex VIII, Sections 5.4 and 6.3). Disputes on classification go to the competent authority of the manufacturer's Member State (Art. 51(2)). The class determines the route under Article 52. Class III devices follow Annex IX, or Annex X type examination with Annex XI product verification. Class IIb devices follow Annex IX with a technical-documentation assessment of at least one representative device per generic device group, and of every device for class IIb implantables except the well-established types listed in Article 52(4), a list Delegated Regulation (EU) 2026/1359 extended on 19 July 2026. Class IIa devices follow Annex IX or Annex XI with a representative-device assessment per category. Class I manufacturers issue the EU declaration of conformity on their own technical documentation, unless the device is sterile, has a measuring function or is a reusable surgical instrument, in which case a notified body checks those aspects (Art. 52(3) to (7)). Custom-made devices follow Annex XIII; class III custom-made implantables have needed a notified body since 26 May 2026 (Art. 52(8) and Art. 120(3f)). Investigational devices follow the clinical-investigation chapter instead (Art. 52(13)). ### General requirements, clinical evaluation and quality management Every device must meet the general safety and performance requirements of Annex I for its intended purpose, and demonstrating that includes a clinical evaluation under Article 61 and Annex XIV with post-market clinical follow-up (Art. 5(2) and (3), Art. 10(3)). Implantable and class III devices need clinical investigations unless one of the Article 61(4) to (6) exceptions applies; Delegated Regulation (EU) 2026/1451 lengthened the list of well-established device types exempt from that obligation, without removing the clinical evaluation itself. Manufacturers run a risk management system (Art. 10(2)), a quality management system proportionate to the risk class covering the thirteen elements of Article 10(9), and have a person responsible for regulatory compliance with the qualifications of Article 15; micro and small enterprises may have that person permanently at their disposal rather than on staff (Art. 15(2)). Under Annex I, Section 10.4.1, devices or parts that are invasive and in direct contact with the body, or that administer, transport or store medicines, body fluids or other substances, may contain CMR substances of category 1A or 1B or endocrine-disrupting substances in a concentration above 0,1 % weight by weight only where justified under Section 10.4.2; since 1 January 2026 the endocrine-disruptor reference follows the CLP Regulation's Category 1 and the guidelines are prepared by ECHA (Regulation (EU) 2025/2457, Art. 3). ### Technical documentation, declaration and CE marking The technical documentation of Annexes II and III must allow conformity to be assessed and be kept up to date (Art. 10(4)); the post-market surveillance plan is part of it (Art. 84). The EU declaration of conformity contains at least the Annex IV information and the Basic UDI-DI, is continuously updated, is translated into the languages the Member States require and, where other Union acts also require a declaration, is a single declaration covering all of them (Art. 19 and Art. 27(6)). The CE marking is affixed visibly, legibly and indelibly to the device or its sterile packaging, otherwise to the packaging, and also appears in the instructions for use and on sales packaging, followed by the notified body's identification number where applicable (Art. 20). Manufacturers keep the documentation, declaration and certificates for at least 10 years after the last device was placed on the market, 15 years for implantables; authorised representatives and importers keep copies for the same period (Art. 10(8), Art. 11(3) and Art. 13(9)). Custom-made and investigational devices carry no CE marking (Art. 21). ### UDI, registration and Eudamed Every device other than custom-made and investigational devices receives a UDI made of a device identifier (UDI-DI) and a production identifier (UDI-PI), created under the rules of a designated issuing entity; the UDI carrier goes on the label and every higher packaging level, and the Basic UDI-DI appears on the declaration of conformity (Art. 27). The label dates were staggered: 26 May 2021 for implantable and class III devices, 26 May 2023 for classes IIa and IIb, 26 May 2025 for class I, with direct marking of reusable devices two years later in each case (Art. 123(3), points (f) and (g)). Contact lenses share a Master UDI-DI since 9 November 2025 and spectacles will from 1 November 2028 (Delegated Regulations (EU) 2023/2197 and 2025/1920). Manufacturers, authorised representatives and importers register in Eudamed and receive a single registration number (SRN) from their competent authority before placing a device on the market, update their data within a week of any change and confirm it after one year and every second year (Art. 30 and Art. 31). Manufacturers register each device with its Basic UDI-DI and the Annex VI core data (Art. 29). Eudamed comprises seven electronic systems (Art. 33); Regulation (EU) 2024/1860 allowed them to become mandatory one by one, six months after the Commission's functionality notice. Commission Decision (EU) 2025/2371 of 27 November 2025 gave that notice for the actor, UDI and device, certificate and market-surveillance modules, so their use is mandatory from 28 May 2026; devices placed on the market from that date must be entered within 12 months of the notice and notified bodies must enter their certificates within 18 months (Art. 123(3), points (d) to (ea)). The vigilance and clinical-investigation modules are still under development. Member States may keep national registration of distributors (Art. 30(2)); Denmark does. ### Information, implant card and summary of safety The label and instructions for use carry the Annex I, Section 23 information in the official language(s) of the Member State where the device reaches the user or patient (Art. 10(11)). Manufacturers of implantable devices supply an implant card and patient information, except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors (Art. 18). For implantable and class III devices a summary of safety and clinical performance is validated by the notified body and published in Eudamed (Art. 32). Misleading claims about intended purpose, safety or performance are prohibited (Art. 7). ### Post-market surveillance, vigilance and supply Each device has a post-market surveillance system and plan; class I manufacturers write a post-market surveillance report and class IIa, IIb and III manufacturers a periodic safety update report, updated at least every two years for class IIa and annually for classes IIb and III, and submitted through Eudamed to the notified body for class III and implantable devices (Art. 83 to 86). Serious incidents are reported immediately and no later than 15 days after awareness, 2 days for a serious public health threat, 10 days for death or an unanticipated serious deterioration in health; field safety corrective actions are reported in advance and communicated to users through field safety notices, and statistically significant increases in non-serious incidents are trend-reported (Art. 87 to 89). Since 10 January 2025 manufacturers must give at least 6 months' notice of an anticipated interruption or discontinuation of supply that could cause serious harm, and every operator passes the information down the chain (Art. 10a). ### Obligations by role Manufacturers carry the design, classification, clinical, documentation, declaration, marking, UDI, registration, surveillance, vigilance and corrective-action duties (Art. 10). Authorised representatives act under a mandate covering at least the Article 11(3) tasks, keep the documents, register, cooperate with authorities and are jointly liable where a non-EU manufacturer fails its duties (Art. 11). Importers verify the CE marking, declaration, labelling, representative and UDI before placing a device on the market, add their identification, register and add themselves to the device registration, guard storage and transport, keep a complaints register and forward incident reports (Art. 13). Distributors verify the same points before making a device available, keep the manufacturer's storage conditions, forward complaints and incident reports and cooperate on corrective action (Art. 14). Relabelling or repackaging by importers or distributors requires a certified quality management system and 28 days' notice (Art. 16(2) to (4)). ### Legacy devices until 2027 and 2028 Devices with a directive certificate that was still valid on 26 May 2021 may be placed on the market or put into service until 31 December 2027 for class III and class IIb implantable devices (other than the sutures, staples, screws and similar items listed in Article 120(3a)) and until 31 December 2028 for the other class IIb devices, class IIa devices and sterile or measuring class I devices; class I devices up-classified by the regulation also have until 31 December 2028 (Art. 120(3a) and (3b)). The conditions are continued compliance with the directive, no significant change, no unacceptable risk, a quality management system and a notified-body application by 26 May 2024 and a written agreement by 26 September 2024 (Art. 120(3c)). The MDR rules on post-market surveillance, market surveillance, vigilance and registration already apply to these devices (Art. 120(3d)), and devices lawfully placed on the market may continue to be made available without a sell-off deadline (Art. 120(4)). ### What may change: the December 2025 proposal On 16 December 2025 the Commission adopted proposal COM(2025) 1023 for a regulation amending the MDR and the IVDR to simplify and reduce the burden of the rules, including more risk-based assessment and a periodic review instead of re-certification. It is a proposal under the ordinary legislative procedure and not yet law; nothing on this page relies on it. ## Enforcement and penalties The regulation carries its own market-surveillance chapter. Competent authorities check devices through documentation reviews, physical and laboratory checks and announced or unannounced inspections of economic operators, suppliers and subcontractors, may demand documentation, information and free samples, and may confiscate, destroy or render inoperable devices presenting an unacceptable risk or falsified devices (Art. 93). Where a device presents an unacceptable risk, they require corrective action, restriction, specific conditions, withdrawal or recall within a set period and, if the operator fails to act, prohibit or restrict its making available, withdraw or recall it and notify the Commission and the other Member States, which then take corresponding measures unless the Commission finds the measure unjustified (Art. 95 and Art. 96). Other non-compliance must be ended within a set period, otherwise the same measures follow (Art. 97), and a Member State may take preventive health-protection measures against a category of devices (Art. 98). A manufacturer that does not cooperate or supplies incomplete information can see its device prohibited, restricted, withdrawn or recalled until it complies (Art. 10(14)). The CE marking follows the general principles of Article 30 of Regulation (EC) No 765/2008, which remains in force (Art. 20(2)). Penalties are national: Member States lay down effective, proportionate and dissuasive penalties and notified them to the Commission by 25 February 2021 (Art. 113). In Denmark, Lægemiddelstyrelsen (the Danish Medicines Agency) supervises manufacturers and the other operators, handles incident reports, verifies the Eudamed actor registrations that lead to the single registration number and registers Danish distributors and specialist retailers. The Danish framework is the Danish act on medical devices (lovbekendtgørelse nr. 682 af 29. maj 2023, as amended by lov nr. 1759 af 29. december 2025), whose § 3 names Lægemiddelstyrelsen as the competent authority, bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (in force 1 January 2026) and the fee orders bekendtgørelse nr. 839 af 20. juni 2023 (as amended) and bekendtgørelse nr. 1733 af 8. december 2025. Importers and distributors established in Denmark (and specialist retailers) also notify Lægemiddelstyrelsen nationally under §§ 14 and 15 of bekendtgørelse nr. 1731, separately from Eudamed, while shops that only sell devices at retail are exempt unless they are specialist retailers (§ 14, stk. 6). Breaches of the MDR and of orders, prohibitions or information duties under it are punishable in Denmark by a fine or imprisonment of up to one year and six months (§ 6(2) of the act on medical devices), with liability for companies (§ 6(4)); failure to make the national notifications of §§ 12 to 15 of bekendtgørelse nr. 1731 is punishable by a fine (§ 20). ## How Conphora helps Conphora monitors the MDR, its delegated acts and the Eudamed timeline and maps your devices against the class-specific route, the documentation, the UDI and registration duties and the vigilance clocks, flagging gaps before a notified body or Lægemiddelstyrelsen does. The platform keeps your declaration of conformity, certificates and 10- or 15-year records in one place and alerts you when a date moves, from the Eudamed backlog deadline to the legacy cut-offs of 31 December 2027 and 2028. [See how Conphora works](/how-it-works) · [See plans and pricing](/pricing) ## Sources - [Regulation (EU) 2017/745 on medical devices, consolidated text of 19 July 2026 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719) - [Regulation (EU) 2017/745 as published in OJ L 117, 5 May 2017 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745) - [Regulation (EU) 2020/561 postponing the date of application (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R0561) - [Regulation (EU) 2023/607 extending the transitional provisions (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607) - [Regulation (EU) 2024/1860 on the gradual roll-out of Eudamed and Article 10a (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860) - [Commission Decision (EU) 2025/2371 on the functionality of the first four Eudamed modules (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371) - [Commission Delegated Regulations (EU) 2026/1359 and 2026/1451 on well-established devices (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1451) - [EUDAMED overview and mandatory-use timeline (European Commission)](https://health.ec.europa.eu/medical-devices-eudamed/overview_en) - [MDCG endorsed guidance documents (European Commission)](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) - [Proposal COM(2025) 1023 to simplify the rules on medical devices (European Commission)](https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en) - [Medicinsk udstyr, registrering, gebyrer og lovgivning (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/) - [Lovbekendtgørelse nr. 682 af 29. maj 2023 af lov om medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2023/682) - [Lov nr. 1759 af 29. december 2025 om ændring af lov om medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1759) - [Bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1731) - [Bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1733) *This guide is for general information and is not legal advice.* ## Sources - [Regulation (EU) 2017/745 on medical devices, consolidated text of 19 July 2026 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719) - [Regulation (EU) 2017/745 as published in OJ L 117, 5 May 2017 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745) - [Document information, dates and relationships for CELEX 32017R0745 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32017R0745) - [Regulation (EU) 2020/561 postponing the date of application to 26 May 2021 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R0561) - [Commission Delegated Regulation (EU) 2023/502 on the frequency of complete re-assessments of notified bodies (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0502) - [Regulation (EU) 2023/607 extending the transitional provisions for legacy devices (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607) - [Commission Delegated Regulation (EU) 2023/2197 on the Master UDI-DI for contact lenses (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R2197) - [Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0568) - [Regulation (EU) 2024/1860 on the gradual roll-out of Eudamed and the supply-interruption notice (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1860) - [Commission Delegated Regulation (EU) 2025/1920 on the Master UDI-DI for spectacle frames, lenses and reading spectacles (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R1920) - [Regulation (EU) 2025/2457 on the reattribution of scientific tasks on chemicals, amending Annex I, Section 10.4 (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R2457) - [Commission Delegated Regulation (EU) 2026/1359 on class IIb implantables exempt from device-by-device documentation assessment (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1359) - [Commission Delegated Regulation (EU) 2026/1451 on implantable and class III devices exempt from clinical investigations (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32026R1451) - [Commission Decision (EU) 2025/2371 on the functionality of the first four Eudamed electronic systems (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025D2371) - [Medical devices, new regulations: overview (European Commission, DG SANTE)](https://health.ec.europa.eu/medical-devices-new-regulations/overview_en) - [EUDAMED overview and mandatory-use timeline (European Commission, DG SANTE)](https://health.ec.europa.eu/medical-devices-eudamed/overview_en) - [MDCG endorsed guidance documents (European Commission, DG SANTE)](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) - [Proposal COM(2025) 1023 of 16 December 2025 to simplify the rules on medical devices and in vitro diagnostics (European Commission)](https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en) - [Medicinsk udstyr (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/) - [Registrering af virksomheder, Eudamed and Lægemiddelstyrelsen's database (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/registrering/) - [Registrering i Eudamed from 28 May 2026 (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-i-eudamed/) - [Registrering af distributører og specialforretninger (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/registrering/registrering-af-distributoer-og-specialforretning/) - [Gebyrer for medicinsk udstyr (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/gebyrer/) - [Lovgivning for medicinsk udstyr, Danish acts and executive orders (Lægemiddelstyrelsen)](https://laegemiddelstyrelsen.dk/da/udstyr/lovgivning-og-vejledning/lovgivning/) - [Lovbekendtgørelse nr. 682 af 29. maj 2023 af lov om medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2023/682) - [Lov nr. 1759 af 29. december 2025 om ændring af lov om medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1759) - [Bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1731) - [Bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr (Retsinformation)](https://www.retsinformation.dk/eli/lta/2025/1733) _Reviewed 2026-09-24 by Conphora compliance team_