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), or the consolidated text of 19 July 2026 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 · See plans and pricing
Sources
- Regulation (EU) 2017/745 on medical devices, consolidated text of 19 July 2026 (EUR-Lex)
- Regulation (EU) 2017/745 as published in OJ L 117, 5 May 2017 (EUR-Lex)
- Regulation (EU) 2020/561 postponing the date of application (EUR-Lex)
- Regulation (EU) 2023/607 extending the transitional provisions (EUR-Lex)
- Regulation (EU) 2024/1860 on the gradual roll-out of Eudamed and Article 10a (EUR-Lex)
- Commission Decision (EU) 2025/2371 on the functionality of the first four Eudamed modules (EUR-Lex)
- Commission Delegated Regulations (EU) 2026/1359 and 2026/1451 on well-established devices (EUR-Lex)
- EUDAMED overview and mandatory-use timeline (European Commission)
- MDCG endorsed guidance documents (European Commission)
- Proposal COM(2025) 1023 to simplify the rules on medical devices (European Commission)
- Medicinsk udstyr, registrering, gebyrer og lovgivning (Lægemiddelstyrelsen)
- Lovbekendtgørelse nr. 682 af 29. maj 2023 af lov om medicinsk udstyr (Retsinformation)
- Lov nr. 1759 af 29. december 2025 om ændring af lov om medicinsk udstyr (Retsinformation)
- Bekendtgørelse nr. 1731 af 8. december 2025 om medicinsk udstyr m.v. (Retsinformation)
- Bekendtgørelse nr. 1733 af 8. december 2025 om gebyrer for importører og distributører af medicinsk udstyr (Retsinformation)
This guide is for general information and is not legal advice.