{ "$schema": "https://www.conphora.com/schemas/regulation-page.json", "code": "PPE", "locale": "en", "url": "https://www.conphora.com/regulations/ppe/", "json": "https://www.conphora.com/regulations/ppe.json", "summaryPdf": "https://www.conphora.com/regulations/ppe/summary.pdf", "dateModified": "2026-09-11", "regulation": { "code": "PPE", "name": "Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC", "shortName": "PPE Regulation", "reference": "Regulation (EU) 2016/425", "celex": "32016R0425", "eurlex": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425", "actType": "Regulation", "category": "CE / Product Safety", "inForce": "2016-04-20", "appliesFrom": "2018-04-21", "changing": false, "video": "regulation-ppe" }, "answer": "The PPE Regulation sets essential requirements for personal protective equipment in the EU, with three risk categories deciding the notified body's role and duties for manufacturers, authorised representatives, importers and distributors. It has applied since 21 April 2018, replacing Directive 89/686/EEC; the emergency procedures added by Regulation (EU) 2024/2748 apply from 29 May 2026.", "description": "PPE guide: the PPE Regulation (EU) 2016/425, who it applies to, the three risk categories and their conformity routes, the exclusions, key dates and how to reach CE marking.", "enforcedBy": "National market surveillance authorities enforce the regulation with the powers of Regulation (EU) 2019/1020 (Article 37 still cites Articles 15(3) and 16 to 29 of Regulation (EC) No 765/2008, read as Regulation (EU) 2019/1020 since 16 July 2021); in Denmark, Sikkerhedsstyrelsen, since January 2026 the Markedsovervågning department of Erhvervsstyrelsen, is the control authority for PPE placed on the market under the Danish product act (lovbekendtgørelse nr. 22 of 8 January 2026), having taken over from Arbejdstilsynet on 1 December 2018, while Arbejdstilsynet remains the authority for the use of PPE at work and for made-to-order or third-country PPE for offshore oil and gas activities. The toolkit is corrective action within a period commensurate with the risk, prohibition or restriction of the making available, withdrawal or recall, orders to end formal non-compliance such as missing CE marking, notified-body number, declaration or technical documentation, and national penalties that must be effective, proportionate and dissuasive and may include criminal penalties for serious infringements; in Denmark the product act allows orders, sales stops, withdrawal, recall and destruction, and fines or, under aggravating circumstances, imprisonment of up to two years.", "keyDates": [ { "date": "2016-03-09", "label": "Regulation (EU) 2016/425 adopted by the European Parliament and the Council", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · title" }, { "date": "2016-04-20", "label": "Entry into force, the twentieth day after publication in OJ L 81 of 31 March 2016", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 48(1)" }, { "date": "2016-10-21", "label": "Articles 20 to 36 on the notification of conformity assessment bodies and Article 44 on the committee procedure apply, so that notified bodies could be designated before the general application date", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 48(2), point (a)" }, { "date": "2018-03-21", "label": "Article 45(1) applies: deadline for Member States to notify the Commission of their penalty rules", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 45(1) and Art. 48(2), point (b)" }, { "date": "2018-04-21", "label": "The regulation applies in full and Directive 89/686/EEC is repealed; in Denmark, executive order nr. 210 of 14 March 2018 with supplementary Danish-language requirements enters into force the same day", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 46 and Art. 48(2); https://www.retsinformation.dk/eli/lta/2018/210 · § 10" }, { "date": "2018-12-01", "label": "Sikkerhedsstyrelsen takes over the control of PPE products placed on the Danish market from Arbejdstilsynet, which remains the authority for the use of PPE at work", "source": "https://www.sik.dk/erhverv/produkter/personlige-vaernemidler/love-og-regler/regler-personlige-vaernemidler" }, { "date": "2019-04-21", "label": "End of the transitional period: PPE conforming to Directive 89/686/EEC and placed on the market before this date may still be made available", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 47(1)" }, { "date": "2023-04-21", "label": "EC type-examination certificates and approval decisions issued under Directive 89/686/EEC cease to be valid unless they expired earlier; the Commission's five-year power to reclassify risks by delegated act is tacitly extended", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 47(2) and Art. 43(2)" }, { "date": "2024-11-28", "label": "Regulation (EU) 2024/2748 in force: definitions of crisis-relevant goods and internal market emergency mode added to Article 3, Chapter VIa (Articles 41a to 41e) inserted", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R2748 · Art. 3 and Art. 7" }, { "date": "2025-04-22", "label": "Corrigendum to Regulation (EU) 2024/2748 published: the provision that survives the emergency mode in Article 41a(3) is Article 41c(7), the CE-marking derogation for nationally authorised PPE", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0425-20260529 · Art. 41a(3), second subparagraph (C1)" }, { "date": "2026-05-29", "label": "Regulation (EU) 2024/2748 applies: the emergency procedures of Chapter VIa can be activated for PPE designated as crisis-relevant goods", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R2748 · Art. 7" }, { "date": "2026-05-30", "label": "Executive order nr. 488 of 28 May 2026 in force: executive order nr. 210 re-based on the product act, Erhvervsstyrelsen replaces Arbejdstilsynet as designating and complaints authority, Danish/English labelling of crisis-relevant PPE", "source": "https://www.retsinformation.dk/eli/lta/2026/488" } ], "amendedBy": [ { "reference": "Regulation (EU) 2024/2748", "celex": "32024R2748", "date": "2024-11-28", "summary": "The internal market emergency regulation of 9 October 2024, published in the Official Journal on 8 November 2024, in force from 28 November 2024 and applying from 29 May 2026, adds the definitions of crisis-relevant goods and internal market emergency mode as Article 3, points (19) and (20), and inserts Chapter VIa (Articles 41a to 41e) on prioritised conformity assessment, national authorisations to place PPE on the market without the mandatory notified-body procedure, presumption of conformity based on standards and common specifications, and prioritised market surveillance while an internal market emergency mode under Regulation (EU) 2024/2747 is active. A corrigendum of 22 April 2025 corrected the cross-reference in Article 41a(3) from Article 41d(7) to Article 41c(7).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R2748 · Art. 3 and Art. 7; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0425-20260529 · Art. 3, points (19) and (20), and Art. 41a" } ], "scope": { "appliesTo": [ "Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety, for professional and private use alike", "Interchangeable components for such equipment that are essential for its protective function, and connexion systems that link the equipment to an external device or a reliable anchorage point without being permanently fixed", "Products such as protective eyewear, hearing protectors, respiratory protective devices, protective clothing, fall protection, safety footwear and protective gloves, in whichever of the three risk categories of Annex I they fall", "PPE made available on the Union market in the course of a commercial activity, whether in return for payment or free of charge, including PPE displayed at trade fairs only when it complies or is visibly marked as not yet compliant", "The economic operators in the chain: manufacturers, authorised representatives, importers and distributors" ], "derived": [ "An importer or distributor that places PPE on the market under its own name or trademark, or modifies PPE already on the market in a way that may affect compliance, is treated as the manufacturer (Art. 12)", "Protective clothing containing removable protectors is PPE and is assessed as a combination (Annex II, point 1.3.4)", "Category III PPE produced as a single unit to fit an individual user may follow the category II procedure, EU type-examination followed by conformity to type based on internal production control (Art. 19, last subparagraph)", "The regulation governs design and marketing only; Member States may still lay down requirements on the use of PPE, notably under Directive 89/656/EEC on PPE at work, as long as they do not affect the design of compliant PPE (Art. 6)", "Where PPE is subject to more than one Union act requiring an EU declaration of conformity, a single declaration covering all of them is drawn up (Art. 15(3))", "PPE designated as crisis-relevant goods during an internal market emergency mode can be placed on the market under a national authorisation without the CE marking and with prioritised notified-body handling (Art. 41a to Art. 41e, from 29 May 2026)" ], "categories": [ { "id": "ppe-category-i", "label": "PPE against minimal risks (category I): superficial mechanical injury, weak cleaning materials or prolonged contact with water, hot surfaces up to 50 °C, sunlight to the eyes, non-extreme atmospheric conditions" }, { "id": "ppe-category-ii", "label": "PPE against risks that are neither category I nor category III (category II), for example impact from falling objects, slipping or mechanical vibration" }, { "id": "ppe-category-iii", "label": "PPE against risks that may cause death or irreversible damage to health (category III): hazardous substances, oxygen deficiency, biological agents, ionising radiation, extreme heat or cold, falls from a height, electric shock, drowning, chainsaw cuts, high-pressure jets, bullet wounds or knife stabs, harmful noise" }, { "id": "ppe-component", "label": "Interchangeable component essential to the protective function, or a connexion system to an external device or anchorage point" }, { "id": "sports-protective-equipment", "label": "Protective equipment for sporting activities, including self-defence PPE intended for sport" }, { "id": "private-non-extreme-weather", "label": "PPE designed for private use against non-extreme atmospheric conditions, or against damp and water during dishwashing" }, { "id": "military-law-enforcement", "label": "PPE specifically designed for use by the armed forces or in the maintenance of law and order" }, { "id": "self-defence", "label": "PPE designed for self-defence, other than PPE intended for sporting activities" }, { "id": "vessel-aircraft", "label": "PPE for exclusive use on seagoing vessels or aircraft subject to the relevant international treaties" }, { "id": "motorcycle-helmet", "label": "Head, face or eye protection for motorcycle and moped riders covered by UNECE Regulation No 22" } ], "roles": [ { "id": "manufacturer", "label": "Manufacturer (including brand owners)", "definition": "Any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark; an importer or distributor that sells under its own name or trademark, or modifies PPE in a way that may affect compliance, is treated as the manufacturer.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 3, point (4), and Art. 12" }, { "id": "other", "label": "Authorised representative", "definition": "Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; the mandate cannot cover the duty to design and manufacture to the essential requirements or to draw up the technical documentation.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 3, point (5), and Art. 9(1)" }, { "id": "importer", "label": "Importer", "definition": "Any natural or legal person established within the Union who places PPE from a third country on the Union market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 3, point (6)" }, { "id": "distributor", "label": "Distributor (wholesaler or retailer)", "definition": "Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 3, point (7)" } ], "rules": [ { "categories": [ "private-non-extreme-weather", "military-law-enforcement", "self-defence", "vessel-aircraft", "motorcycle-helmet" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "Article 2(2) excludes five groups: PPE specifically designed for the armed forces or the maintenance of law and order; PPE for self-defence other than for sporting activities; PPE for private use against non-extreme atmospheric conditions or against damp and water during dishwashing; PPE for exclusive use on seagoing vessels or aircraft subject to international treaties; and helmets and visors for motorcycle and moped riders covered by UNECE Regulation No 22. Such products may still fall under other Union or national rules, such as the General Product Safety Regulation.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 2(2)" }, { "categories": [ "ppe-category-iii" ], "roles": [ "manufacturer", "importer", "distributor", "other" ], "size": "any", "result": "in-scope", "note": "Category III PPE must undergo EU type-examination by a notified body (module B, Annex V) and then either supervised product checks at random intervals (module C2, Annex VII) or quality assurance of the production process (module D, Annex VIII); the CE marking is followed by the notified body's identification number. PPE produced as a single unit for an individual user may use the category II route instead. The obligations fall on the economic operators in the chain and contain no company-size threshold.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 17(3), Art. 18, Art. 19, point (c), and Annex I" }, { "categories": [ "ppe-category-ii" ], "roles": [ "manufacturer", "importer", "distributor", "other" ], "size": "any", "result": "in-scope", "note": "Category II PPE must undergo EU type-examination by a notified body (module B, Annex V) followed by conformity to type based on internal production control (module C, Annex VI); no notified-body number follows the CE marking. The obligations fall on the economic operators in the chain and contain no company-size threshold.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 18, Art. 19, point (b), and Annex I" }, { "categories": [ "ppe-category-i" ], "roles": [ "manufacturer", "importer", "distributor", "other" ], "size": "any", "result": "in-scope", "note": "Category I PPE, against the five minimal risks listed exhaustively in Annex I, is assessed by the manufacturer alone through internal production control (module A, Annex IV) with technical documentation, an EU declaration of conformity and the CE marking. The obligations fall on the economic operators in the chain and contain no company-size threshold.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 18, Art. 19, point (a), and Annex I" }, { "categories": [ "ppe-component", "sports-protective-equipment" ], "roles": [ "manufacturer", "importer", "distributor", "other" ], "size": "any", "result": "in-scope", "note": "Interchangeable components essential to the protective function and non-fixed connexion systems are PPE in their own right, and self-defence PPE intended for sporting activities is expressly kept inside the scope; the applicable procedure follows the Annex I category of the risk the equipment protects against.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 2(2), point (b), Art. 3, point (1), and Art. 18" }, { "categories": [ "*" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Whether the regulation applies turns on whether the product is designed to be worn or held for protection against a health or safety risk, whether an Article 2(2) exclusion applies, which Annex I risk category the protected risk falls into, and which role the operator holds.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 2, Art. 3, point (1), and Art. 18" } ] }, "obligations": { "manufacturer": [ { "text": "Carry out a risk assessment to identify the risks your PPE protects against, and design and manufacture it to the applicable essential health and safety requirements of Annex II, taking into account the intended and the reasonably foreseeable uses.", "id": "ppe-mfr-carry-out-risk", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 5, Art. 8(1) and Annex II, preliminary remarks 4 and 5" }, { "text": "Carry out a risk assessment to identify the risks your PPE is intended to protect against and the essential health and safety requirements that apply to it.", "id": "ppe-mfr-carry-out-risk-assessment", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(1) and Annex II, preliminary remark 4" }, { "text": "Design and manufacture the PPE to the applicable essential health and safety requirements of Annex II, taking into account the intended and the reasonably foreseeable uses.", "id": "ppe-mfr-design-to-annex-ii", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 5, Art. 8(1) and Annex II, preliminary remark 5" }, { "text": "Classify the PPE into risk category I, II or III according to Annex I and run the matching procedure: internal production control (module A) for category I; EU type-examination (module B) plus conformity to type (module C) for category II; EU type-examination plus either supervised product checks at random intervals (module C2) or quality assurance of the production process (module D) for category III.", "id": "ppe-mfr-classify-ppe-risk", "kind": "decision", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 18 and Art. 19" }, { "text": "Classify the PPE into risk category I, II or III according to Annex I.", "id": "ppe-mfr-classify-risk-category", "kind": "decision", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 18 and Annex I" }, { "text": "Run the conformity assessment procedure for the category: internal production control (module A) for category I; EU type-examination (module B) plus module C for category II; EU type-examination plus module C2 or module D for category III.", "id": "ppe-mfr-run-conformity-assessment", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 19" }, { "text": "Draw up the Annex III technical documentation, and once conformity is demonstrated the EU declaration of conformity in the Annex IX structure, translated into the languages the Member State requires; affix the CE marking before placing on the market and keep both documents for 10 years after the PPE was placed on the market.", "id": "ppe-mfr-draw-annex-iii", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(2), Art. 8(3), Art. 15 and Art. 17(2)" }, { "text": "Draw up the Annex III technical documentation for the PPE.", "id": "ppe-mfr-draw-technical-documentation", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(2) and Annex III" }, { "text": "Once conformity is demonstrated, draw up the EU declaration of conformity in the Annex IX structure, translated into the languages the Member State requires.", "id": "ppe-mfr-draw-eu-declaration", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(2) and Art. 15" }, { "text": "Affix the CE marking visibly, legibly and indelibly to the PPE before placing it on the market.", "id": "ppe-mfr-affix-ce-marking", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(2) and Art. 17(2)" }, { "text": "Keep the technical documentation and the EU declaration of conformity for 10 years after the PPE was placed on the market.", "id": "ppe-mfr-keep-documentation-years", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(3)" }, { "text": "For category III PPE, have the CE marking followed by the identification number of the notified body involved in the module C2 or module D procedure; a pictogram indicating the risk protected against may follow. An EU type-examination certificate is valid for at most five years, and the renewal application must reach the notified body between 12 and 6 months before expiry.", "id": "ppe-mfr-have-marking-followed", "kind": "mark", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 17(3), Art. 17(4) and Annex V, points 6.1 and 7.4" }, { "text": "For category III PPE, have the CE marking followed by the identification number of the notified body involved in the module C2 or module D procedure; a pictogram indicating the risk protected against may follow.", "id": "ppe-mfr-add-notified-body-number", "kind": "mark", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 17(3) and Art. 17(4)" }, { "text": "Renew the EU type-examination certificate, valid for at most five years, by applying to the notified body between 12 and 6 months before it expires.", "id": "ppe-mfr-renew-type-certificate", "kind": "submission", "level": "product", "timing": "periodic", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Annex V, points 6.1 and 7.4" }, { "text": "Keep series production in conformity, taking account of design changes and changes to the harmonised standards or technical specifications relied on, and where the risks warrant it sample-test marketed PPE, investigate complaints and keep a register of complaints, non-conforming PPE and recalls, informing distributors.", "id": "ppe-mfr-keep-series-production", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(4)" }, { "text": "Keep series production in conformity, taking account of design changes and changes to the harmonised standards or technical specifications relied on.", "id": "ppe-mfr-maintain-series-conformity", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(4)" }, { "text": "Where the risks warrant it, sample-test marketed PPE, investigate complaints, keep a register of complaints, non-conforming PPE and recalls, and keep distributors informed of that monitoring.", "id": "ppe-mfr-sample-test-register", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(4)" }, { "text": "Mark the PPE with a type, batch or serial number or other identifier and with your name, registered trade name or trade mark and a single postal contact address, on the PPE itself or, where its size or nature does not allow it, on the packaging or in an accompanying document, in a language end-users and authorities can easily understand.", "id": "ppe-mfr-mark-ppe-type", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(5) and Art. 8(6)" }, { "text": "Supply the instructions and information of Annex II, point 1.4, in a language the Member State determines (Danish in Denmark), covering storage, use, cleaning, maintenance, performance levels, obsolescence, markings, the risk protected against, the notified body and the standards applied, and either enclose the EU declaration of conformity or give the internet address where it can be accessed.", "id": "ppe-mfr-supply-instructions-information", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(7), Art. 8(8) and Annex II, point 1.4; https://www.retsinformation.dk/eli/lta/2018/210 · § 5" }, { "text": "If you consider or have reason to believe that PPE you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent authorities of the Member States where you made it available, with details of the non-conformity and the corrective measures.", "id": "ppe-mfr-immediately-bring-conformity", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(9)" }, { "text": "On a reasoned request, provide all information and documentation demonstrating conformity in paper or electronic form in a language the authority can easily understand, cooperate on risk-elimination measures, and be able to identify who supplied you and whom you supplied for 10 years.", "id": "ppe-mfr-provide-information-documentation", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(10) and Art. 13" }, { "text": "On a reasoned request, provide the authority with all information and documentation demonstrating conformity, in paper or electronic form and a language it easily understands, and cooperate on measures to eliminate the risks.", "id": "ppe-mfr-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(10)" }, { "text": "Be able to identify to the market surveillance authorities, for 10 years after each supply, any economic operator who supplied you with PPE and any economic operator you supplied.", "id": "ppe-mfr-identify-suppliers-customers", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 13" } ], "other": [ { "text": "Act under a written mandate that at least lets you keep the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authorities for 10 years after the PPE was placed on the market, provide conformity information and documentation on reasoned request, and cooperate with the authorities on risk-elimination measures.", "id": "ppe-oth-act-written-mandate", "kind": "evidence", "level": "company", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 9(2)" }, { "text": "Act only under a written mandate from the manufacturer that sets out the tasks you perform on its behalf.", "id": "ppe-oth-hold-written-mandate", "kind": "evidence", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 9(1) and Art. 9(2)" }, { "text": "Keep the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authorities for 10 years after the PPE was placed on the market.", "id": "ppe-oth-keep-documentation-years", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 9(2)(a)" }, { "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate with it on measures to eliminate the risks of the PPE covered by your mandate.", "id": "ppe-oth-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 9(2)(b) and Art. 9(2)(c)" }, { "text": "Do not take over the manufacturer's duty to design and manufacture to the essential requirements or to draw up the technical documentation; those cannot form part of the mandate.", "id": "ppe-oth-take-manufacturers-duty", "kind": "status", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 9(1)" }, { "text": "Where the mandate specifies it, lodge the application for EU type-examination, notify the notified body of modifications and ask for the certificate review, affix the CE marking and draw up and keep the EU declaration of conformity on the manufacturer's behalf, and affix the notified body's identification number under its instructions; the manufacturing obligations themselves stay with the manufacturer.", "id": "ppe-oth-lodge-application-type-examination", "kind": "submission", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 17(3), Annex IV, point 5, Annex V, point 10, and Annex VII, point 7" }, { "text": "Where the mandate specifies it, lodge the application for EU type-examination, notify the notified body of modifications and ask for the certificate review on the manufacturer's behalf; the manufacturing obligations stay with the manufacturer.", "id": "ppe-oth-lodge-type-examination", "kind": "submission", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Annex V, point 10" }, { "text": "Where the mandate specifies it, affix the CE marking on the manufacturer's behalf and, under the notified body's instructions, its identification number.", "id": "ppe-oth-affix-ce-marking", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 17(3), Annex IV, point 5, and Annex VII, point 7" }, { "text": "Where the mandate specifies it, draw up and keep the EU declaration of conformity on the manufacturer's behalf.", "id": "ppe-oth-draw-eu-declaration", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "declaration-of-conformity", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Annex IV, point 5, and Annex VII, point 7" }, { "text": "Be able to identify to the market surveillance authorities any operator who supplied you with PPE and any operator you supplied, for 10 years after each supply.", "id": "ppe-oth-able-identify-market", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 13" } ], "importer": [ { "text": "Place only compliant PPE on the market, and before doing so check that the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation, that the PPE bears the CE marking and is accompanied by the required documents, and that it carries the manufacturer's identification, name and address; hold non-conforming PPE back and inform the manufacturer and the market surveillance authorities where it presents a risk.", "id": "ppe-imp-place-compliant-ppe", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(1) and Art. 10(2)" }, { "text": "Indicate your name, registered trade name or trade mark and a postal contact address on the PPE or, where not possible, on its packaging or in an accompanying document, in a language end-users and authorities can easily understand.", "id": "ppe-imp-indicate-name-registered", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(3)" }, { "text": "Ensure the PPE is accompanied by the Annex II, point 1.4, instructions and information in the language the Member State determines, and that storage and transport conditions under your responsibility do not jeopardise conformity with the essential requirements.", "id": "ppe-imp-ensure-ppe-accompanied", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(4) and Art. 10(5)" }, { "text": "Ensure the PPE is accompanied by the Annex II, point 1.4, instructions and information in the language the Member State determines.", "id": "ppe-imp-ensure-instructions-accompany", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(4)" }, { "text": "While PPE is under your responsibility, keep storage and transport conditions from jeopardising its conformity with the essential health and safety requirements.", "id": "ppe-imp-ensure-storage-transport", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(5)" }, { "text": "Where the risks warrant it, sample-test marketed PPE, investigate complaints and keep a register of complaints, non-conforming PPE and recalls, informing distributors.", "id": "ppe-imp-sample-test-marketed-ppe", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(6)" }, { "text": "If PPE you placed on the market does not conform, immediately take corrective measures, withdraw or recall it, and where it presents a risk inform the competent authorities of the Member States concerned with details of the non-conformity and the measures taken.", "id": "ppe-imp-immediately-take-corrective", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(7)" }, { "text": "Keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for 10 years, ensure the technical documentation can be made available on request, provide conformity information on reasoned request in a language the authority understands, cooperate on risk-elimination measures, and identify suppliers and customers for 10 years.", "id": "ppe-imp-keep-copy-declaration", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(8), Art. 10(9) and Art. 13" }, { "text": "Keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for 10 years after placing on the market, and ensure the technical documentation can be made available on request.", "id": "ppe-imp-keep-declaration-copy", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(8)" }, { "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks.", "id": "ppe-imp-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 10(9)" }, { "text": "Be able to identify to the market surveillance authorities, for 10 years after each supply, any economic operator who supplied you with PPE and any economic operator you supplied.", "id": "ppe-imp-identify-suppliers-customers", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 13" }, { "text": "If you place PPE on the market under your own name or trademark, or modify PPE already on the market in a way that may affect compliance, you carry the manufacturer's obligations under Article 8.", "id": "ppe-imp-modify-ppe-already", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 12" } ], "distributor": [ { "text": "Act with due care and, before making PPE available, verify that it bears the CE marking, is accompanied by the required documents and by the Annex II, point 1.4, instructions and information in a language easily understood in the Member State of sale, and that the manufacturer and importer have met their identification and address duties; hold non-conforming PPE back and inform the manufacturer or importer and the market surveillance authorities where it presents a risk.", "id": "ppe-dist-act-due-care", "kind": "verification", "level": "product-market", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 11(1) and Art. 11(2)" }, { "text": "Keep storage and transport conditions under your responsibility from jeopardising conformity with the essential health and safety requirements.", "id": "ppe-dist-keep-storage-transport", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 11(3)" }, { "text": "If PPE you made available does not conform, make sure the corrective measures to bring it into conformity, withdraw or recall it are taken, and where it presents a risk immediately inform the competent authorities of the Member States concerned.", "id": "ppe-dist-make-sure-corrective", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 11(4)" }, { "text": "On reasoned request, provide the information and documentation demonstrating conformity, cooperate on risk-elimination measures, and identify suppliers and customers for 10 years.", "id": "ppe-dist-provide-information-documentation", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 11(5) and Art. 13" }, { "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate on measures to eliminate the risks of PPE you made available.", "id": "ppe-dist-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 11(5)" }, { "text": "Be able to identify to the market surveillance authorities, for 10 years after each supply, any economic operator who supplied you with PPE and any economic operator you supplied.", "id": "ppe-dist-identify-suppliers-customers", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 13" }, { "text": "If you sell under your own name or trademark or modify PPE in a way that may affect compliance, you take on the manufacturer's obligations.", "id": "ppe-dist-take-manufacturers-obligations", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 12" } ] }, "requirements": [ { "id": "ppe-mfr-carry-out-risk", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "retired": "2026-09-24", "text": "Carry out a risk assessment to identify the risks your PPE protects against, and design and manufacture it to the applicable essential health and safety requirements of Annex II, taking into account the intended and the reasonably foreseeable uses.", "article": "Art. 5, Art. 8(1) and Annex II, preliminary remarks 4 and 5", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-carry-out-risk-assessment", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "text": "Carry out a risk assessment to identify the risks your PPE is intended to protect against and the essential health and safety requirements that apply to it.", "article": "Art. 8(1) and Annex II, preliminary remark 4", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-design-to-annex-ii", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "Design and manufacture the PPE to the applicable essential health and safety requirements of Annex II, taking into account the intended and the reasonably foreseeable uses.", "article": "Art. 5, Art. 8(1) and Annex II, preliminary remark 5", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-classify-ppe-risk", "role": "manufacturer", "kind": "decision", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "Classify the PPE into risk category I, II or III according to Annex I and run the matching procedure: internal production control (module A) for category I; EU type-examination (module B) plus conformity to type (module C) for category II; EU type-examination plus either supervised product checks at random intervals (module C2) or quality assurance of the production process (module D) for category III.", "article": "Art. 18 and Art. 19", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-classify-risk-category", "role": "manufacturer", "kind": "decision", "level": "product", "timing": "before-market", "text": "Classify the PPE into risk category I, II or III according to Annex I.", "article": "Art. 18 and Annex I", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-run-conformity-assessment", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "Run the conformity assessment procedure for the category: internal production control (module A) for category I; EU type-examination (module B) plus module C for category II; EU type-examination plus module C2 or module D for category III.", "article": "Art. 19", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-draw-annex-iii", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "text": "Draw up the Annex III technical documentation, and once conformity is demonstrated the EU declaration of conformity in the Annex IX structure, translated into the languages the Member State requires; affix the CE marking before placing on the market and keep both documents for 10 years after the PPE was placed on the market.", "article": "Art. 8(2), Art. 8(3), Art. 15 and Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-draw-technical-documentation", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "text": "Draw up the Annex III technical documentation for the PPE.", "article": "Art. 8(2) and Annex III", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-draw-eu-declaration", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "text": "Once conformity is demonstrated, draw up the EU declaration of conformity in the Annex IX structure, translated into the languages the Member State requires.", "article": "Art. 8(2) and Art. 15", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-affix-ce-marking", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "text": "Affix the CE marking visibly, legibly and indelibly to the PPE before placing it on the market.", "article": "Art. 8(2) and Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-keep-documentation-years", "role": "manufacturer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep the technical documentation and the EU declaration of conformity for 10 years after the PPE was placed on the market.", "article": "Art. 8(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-have-marking-followed", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "For category III PPE, have the CE marking followed by the identification number of the notified body involved in the module C2 or module D procedure; a pictogram indicating the risk protected against may follow. An EU type-examination certificate is valid for at most five years, and the renewal application must reach the notified body between 12 and 6 months before expiry.", "article": "Art. 17(3), Art. 17(4) and Annex V, points 6.1 and 7.4", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-add-notified-body-number", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "text": "For category III PPE, have the CE marking followed by the identification number of the notified body involved in the module C2 or module D procedure; a pictogram indicating the risk protected against may follow.", "article": "Art. 17(3) and Art. 17(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-renew-type-certificate", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "periodic", "text": "Renew the EU type-examination certificate, valid for at most five years, by applying to the notified body between 12 and 6 months before it expires.", "article": "Annex V, points 6.1 and 7.4", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-keep-series-production", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "text": "Keep series production in conformity, taking account of design changes and changes to the harmonised standards or technical specifications relied on, and where the risks warrant it sample-test marketed PPE, investigate complaints and keep a register of complaints, non-conforming PPE and recalls, informing distributors.", "article": "Art. 8(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-maintain-series-conformity", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep series production in conformity, taking account of design changes and changes to the harmonised standards or technical specifications relied on.", "article": "Art. 8(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-sample-test-register", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Where the risks warrant it, sample-test marketed PPE, investigate complaints, keep a register of complaints, non-conforming PPE and recalls, and keep distributors informed of that monitoring.", "article": "Art. 8(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-mark-ppe-type", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Mark the PPE with a type, batch or serial number or other identifier and with your name, registered trade name or trade mark and a single postal contact address, on the PPE itself or, where its size or nature does not allow it, on the packaging or in an accompanying document, in a language end-users and authorities can easily understand.", "article": "Art. 8(5) and Art. 8(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-supply-instructions-information", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "text": "Supply the instructions and information of Annex II, point 1.4, in a language the Member State determines (Danish in Denmark), covering storage, use, cleaning, maintenance, performance levels, obsolescence, markings, the risk protected against, the notified body and the standards applied, and either enclose the EU declaration of conformity or give the internet address where it can be accessed.", "article": "Art. 8(7), Art. 8(8) and Annex II, point 1.4; https://www.retsinformation.dk/eli/lta/2018/210 · § 5", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-immediately-bring-conformity", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "If you consider or have reason to believe that PPE you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent authorities of the Member States where you made it available, with details of the non-conformity and the corrective measures.", "article": "Art. 8(9)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-provide-information-documentation", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "text": "On a reasoned request, provide all information and documentation demonstrating conformity in paper or electronic form in a language the authority can easily understand, cooperate on risk-elimination measures, and be able to identify who supplied you and whom you supplied for 10 years.", "article": "Art. 8(10) and Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-provide-information-request", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with all information and documentation demonstrating conformity, in paper or electronic form and a language it easily understands, and cooperate on measures to eliminate the risks.", "article": "Art. 8(10)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-mfr-identify-suppliers-customers", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify to the market surveillance authorities, for 10 years after each supply, any economic operator who supplied you with PPE and any economic operator you supplied.", "article": "Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-act-written-mandate", "role": "other", "kind": "evidence", "level": "company", "timing": "before-market", "retired": "2026-09-24", "text": "Act under a written mandate that at least lets you keep the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authorities for 10 years after the PPE was placed on the market, provide conformity information and documentation on reasoned request, and cooperate with the authorities on risk-elimination measures.", "article": "Art. 9(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-hold-written-mandate", "role": "other", "kind": "evidence", "level": "company", "timing": "before-market", "text": "Act only under a written mandate from the manufacturer that sets out the tasks you perform on its behalf.", "article": "Art. 9(1) and Art. 9(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-keep-documentation-years", "role": "other", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authorities for 10 years after the PPE was placed on the market.", "article": "Art. 9(2)(a)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-provide-information-request", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate with it on measures to eliminate the risks of the PPE covered by your mandate.", "article": "Art. 9(2)(b) and Art. 9(2)(c)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-take-manufacturers-duty", "role": "other", "kind": "status", "level": "company", "timing": "before-market", "text": "Do not take over the manufacturer's duty to design and manufacture to the essential requirements or to draw up the technical documentation; those cannot form part of the mandate.", "article": "Art. 9(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-lodge-application-type-examination", "role": "other", "kind": "submission", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "Where the mandate specifies it, lodge the application for EU type-examination, notify the notified body of modifications and ask for the certificate review, affix the CE marking and draw up and keep the EU declaration of conformity on the manufacturer's behalf, and affix the notified body's identification number under its instructions; the manufacturing obligations themselves stay with the manufacturer.", "article": "Art. 17(3), Annex IV, point 5, Annex V, point 10, and Annex VII, point 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-lodge-type-examination", "role": "other", "kind": "submission", "level": "product", "timing": "before-market", "text": "Where the mandate specifies it, lodge the application for EU type-examination, notify the notified body of modifications and ask for the certificate review on the manufacturer's behalf; the manufacturing obligations stay with the manufacturer.", "article": "Annex V, point 10", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-affix-ce-marking", "role": "other", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "text": "Where the mandate specifies it, affix the CE marking on the manufacturer's behalf and, under the notified body's instructions, its identification number.", "article": "Art. 17(3), Annex IV, point 5, and Annex VII, point 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-draw-eu-declaration", "role": "other", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "declaration-of-conformity", "text": "Where the mandate specifies it, draw up and keep the EU declaration of conformity on the manufacturer's behalf.", "article": "Annex IV, point 5, and Annex VII, point 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-oth-able-identify-market", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify to the market surveillance authorities any operator who supplied you with PPE and any operator you supplied, for 10 years after each supply.", "article": "Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-place-compliant-ppe", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "Place only compliant PPE on the market, and before doing so check that the manufacturer has carried out the appropriate conformity assessment procedure and drawn up the technical documentation, that the PPE bears the CE marking and is accompanied by the required documents, and that it carries the manufacturer's identification, name and address; hold non-conforming PPE back and inform the manufacturer and the market surveillance authorities where it presents a risk.", "article": "Art. 10(1) and Art. 10(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-indicate-name-registered", "role": "importer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Indicate your name, registered trade name or trade mark and a postal contact address on the PPE or, where not possible, on its packaging or in an accompanying document, in a language end-users and authorities can easily understand.", "article": "Art. 10(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-ensure-ppe-accompanied", "role": "importer", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "retired": "2026-09-24", "text": "Ensure the PPE is accompanied by the Annex II, point 1.4, instructions and information in the language the Member State determines, and that storage and transport conditions under your responsibility do not jeopardise conformity with the essential requirements.", "article": "Art. 10(4) and Art. 10(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-ensure-instructions-accompany", "role": "importer", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "text": "Ensure the PPE is accompanied by the Annex II, point 1.4, instructions and information in the language the Member State determines.", "article": "Art. 10(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-ensure-storage-transport", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "While PPE is under your responsibility, keep storage and transport conditions from jeopardising its conformity with the essential health and safety requirements.", "article": "Art. 10(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-sample-test-marketed-ppe", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Where the risks warrant it, sample-test marketed PPE, investigate complaints and keep a register of complaints, non-conforming PPE and recalls, informing distributors.", "article": "Art. 10(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-immediately-take-corrective", "role": "importer", "kind": "submission", "level": "product", "timing": "on-event", "text": "If PPE you placed on the market does not conform, immediately take corrective measures, withdraw or recall it, and where it presents a risk inform the competent authorities of the Member States concerned with details of the non-conformity and the measures taken.", "article": "Art. 10(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-keep-copy-declaration", "role": "importer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "text": "Keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for 10 years, ensure the technical documentation can be made available on request, provide conformity information on reasoned request in a language the authority understands, cooperate on risk-elimination measures, and identify suppliers and customers for 10 years.", "article": "Art. 10(8), Art. 10(9) and Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-keep-declaration-copy", "role": "importer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for 10 years after placing on the market, and ensure the technical documentation can be made available on request.", "article": "Art. 10(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-provide-information-request", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks.", "article": "Art. 10(9)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-identify-suppliers-customers", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify to the market surveillance authorities, for 10 years after each supply, any economic operator who supplied you with PPE and any economic operator you supplied.", "article": "Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-imp-modify-ppe-already", "role": "importer", "kind": "status", "level": "product", "timing": "before-market", "text": "If you place PPE on the market under your own name or trademark, or modify PPE already on the market in a way that may affect compliance, you carry the manufacturer's obligations under Article 8.", "article": "Art. 12", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-dist-act-due-care", "role": "distributor", "kind": "verification", "level": "product-market", "timing": "before-market", "text": "Act with due care and, before making PPE available, verify that it bears the CE marking, is accompanied by the required documents and by the Annex II, point 1.4, instructions and information in a language easily understood in the Member State of sale, and that the manufacturer and importer have met their identification and address duties; hold non-conforming PPE back and inform the manufacturer or importer and the market surveillance authorities where it presents a risk.", "article": "Art. 11(1) and Art. 11(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-dist-keep-storage-transport", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep storage and transport conditions under your responsibility from jeopardising conformity with the essential health and safety requirements.", "article": "Art. 11(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-dist-make-sure-corrective", "role": "distributor", "kind": "submission", "level": "product", "timing": "on-event", "text": "If PPE you made available does not conform, make sure the corrective measures to bring it into conformity, withdraw or recall it are taken, and where it presents a risk immediately inform the competent authorities of the Member States concerned.", "article": "Art. 11(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-dist-provide-information-documentation", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "text": "On reasoned request, provide the information and documentation demonstrating conformity, cooperate on risk-elimination measures, and identify suppliers and customers for 10 years.", "article": "Art. 11(5) and Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-dist-provide-information-request", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate on measures to eliminate the risks of PPE you made available.", "article": "Art. 11(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-dist-identify-suppliers-customers", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify to the market surveillance authorities, for 10 years after each supply, any economic operator who supplied you with PPE and any economic operator you supplied.", "article": "Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "id": "ppe-dist-take-manufacturers-obligations", "role": "distributor", "kind": "status", "level": "product", "timing": "before-market", "text": "If you sell under your own name or trademark or modify PPE in a way that may affect compliance, you take on the manufacturer's obligations.", "article": "Art. 12", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" } ], "requirementsHash": "0d93c31010790bfc", "penalties": { "text": "Member States lay down the rules on penalties for infringements of the regulation by economic operators; the penalties must be effective, proportionate and dissuasive and may include criminal penalties for serious infringements. Market surveillance authorities evaluate PPE that presents a risk to health or safety, require corrective action, withdrawal or recall within a period commensurate with the risk, inform the notified body, and if the operator fails to act prohibit or restrict the making available, withdraw or recall the PPE and notify the Commission and the other Member States; compliant PPE that still presents a risk can be treated the same way. Formal non-compliance, such as CE marking affixed wrongly or not at all, a missing or wrongly affixed notified-body number on category III PPE, a missing or incorrect EU declaration of conformity, unavailable or incomplete technical documentation, or absent, false or incomplete manufacturer or importer identification, must be ended and otherwise leads to restriction, prohibition, recall or withdrawal. In Denmark, Erhvervsstyrelsen, which absorbed Sikkerhedsstyrelsen in January 2026 as its Markedsovervågning department, is the control authority under the product act (lovbekendtgørelse nr. 22 of 8 January 2026), which lists the PPE Regulation among the product regulations it enforces and allows the authority to order corrective action, stop sales, withdraw, recall or destroy a product, and to punish breaches of the product regulations with fines or, under aggravating circumstances, imprisonment of up to two years, with liability for companies. Executive order nr. 210 of 14 March 2018, as amended by executive order nr. 488 of 28 May 2026 (in force 30 May 2026, now issued under the product act), adds that PPE may only be placed on the Danish market with the EU declaration of conformity and the instructions in Danish (§ 5), requires crisis-relevant PPE placed on the market under an extended Article 41c(2) authorisation to carry the 'crisis-relevant good' information in Danish or English (§ 5(2)), names Erhvervsstyrelsen as the authority that designates Danish notified bodies and hears complaints about their decisions (§§ 6 and 8), and provides fines for breaches (§ 9).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 45, Art. 38, Art. 40 and Art. 41; https://www.retsinformation.dk/eli/lta/2026/22 · § 2, stk. 1, nr. 40, § 9, § 14 and § 37; https://www.retsinformation.dk/eli/lta/2018/210 · § 5, § 6, § 8 and § 9; https://www.retsinformation.dk/eli/lta/2026/488; https://www.sik.dk/erhverv/produkter/personlige-vaernemidler/vejledninger/kontrol-personlige-vaernemidler" }, "checklist": [ "Confirm the product is PPE under Article 3, point (1): designed to be worn or held for protection against a health or safety risk, or an essential interchangeable component or connexion system, and that none of the five Article 2(2) exclusions applies.", "Decide your role for each product, remembering that selling under your own brand or modifying the PPE makes you the manufacturer (Article 12).", "Run the Annex II risk assessment and classify the PPE into category I, II or III against the Annex I lists; category III is decided by the thirteen risks listed there, category I by the five minimal risks (Article 18).", "Choose the conformity route: module A alone for category I; a notified body's EU type-examination plus module C for category II; EU type-examination plus module C2 or module D for category III, or the category II route for single-unit PPE made for one user (Article 19).", "Compile the Annex III technical documentation, including the risk assessment, the list of applicable essential requirements, the standards applied, test reports and a copy of the instructions, before placing the product on the market (Article 8(2)).", "Draw up the EU declaration of conformity in the Annex IX structure, translated into the languages of the Member States of sale, and keep it and the documentation for 10 years (Articles 8(3) and 15).", "Affix the CE marking to the PPE, or to its packaging and documents where that is not possible, followed by the notified body's number for category III, and add the type or serial number and the manufacturer's and importer's name and address (Articles 8(5), 8(6), 10(3) and 17).", "Write the Annex II, point 1.4, instructions in the language of each Member State of sale, with performance levels, obsolescence, markings, the notified body and the internet address of the declaration (Article 8(7) and 8(8)).", "Diarise the five-year expiry of each EU type-examination certificate and lodge the renewal 12 to 6 months before it (Annex V, points 6.1 and 7.4).", "Set up the corrective-action and notification procedure, 10-year supplier and customer traceability and, where the risks warrant it, a complaints register (Articles 8(4), 8(9), 10(7), 11(4) and 13)." ], "faq": [ { "q": "When did the PPE Regulation start to apply?", "a": "Regulation (EU) 2016/425 entered into force on 20 April 2016, the twentieth day after publication in the Official Journal of 31 March 2016, and has applied in full since 21 April 2018, when it repealed Directive 89/686/EEC. The provisions on notifying conformity assessment bodies applied from 21 October 2016 so that notified bodies could be designated in time. PPE conforming to the old directive and placed on the market before 21 April 2019 could still be made available, and EC type-examination certificates and approval decisions issued under the directive remained valid until 21 April 2023 unless they expired earlier.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 46, Art. 47 and Art. 48" }, { "q": "What counts as PPE and what is excluded?", "a": "PPE is equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety, together with interchangeable components essential to the protective function and non-fixed connexion systems to an external device or anchorage point. The regulation does not apply to PPE specifically designed for the armed forces or the maintenance of law and order, PPE for self-defence except for sporting activities, PPE for private use against non-extreme atmospheric conditions or against damp and water during dishwashing, PPE for exclusive use on seagoing vessels or aircraft subject to international treaties, and motorcycle and moped helmets and visors covered by UNECE Regulation No 22.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 2(2) and Art. 3, point (1)" }, { "q": "What are the three PPE categories and which conformity assessment does each need?", "a": "Annex I sorts PPE by the risk it protects against. Category I covers exclusively five minimal risks: superficial mechanical injury, contact with weak cleaning materials or prolonged contact with water, hot surfaces not exceeding 50 °C, eye damage from sunlight other than when observing the sun, and non-extreme atmospheric conditions; the manufacturer uses internal production control alone. Category III covers exclusively thirteen risks that may cause death or irreversible damage to health: hazardous substances and mixtures, oxygen-deficient atmospheres, harmful biological agents, ionising radiation, high-temperature environments comparable to at least 100 °C, low-temperature environments comparable to minus 50 °C or less, falling from a height, electric shock and live working, drowning, cuts by hand-held chainsaws, high-pressure jets, bullet wounds or knife stabs, and harmful noise; these need EU type-examination plus supervised product checks or production quality assurance by a notified body. Category II is everything in between and needs EU type-examination followed by conformity to type based on internal production control.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 19 and Annex I" }, { "q": "Do I need a notified body for PPE?", "a": "Not for category I, where the manufacturer assesses conformity under Annex IV without third-party involvement. For category II and III a notified body must carry out the EU type-examination of Annex V and issue a certificate valid for at most five years, which the manufacturer must ask to have reviewed before expiry, at the earliest 12 and at the latest 6 months beforehand. For category III the notified body also stays involved in production, either through supervised product checks at least once a year under Annex VII or through audits of an approved quality system at least once a year under Annex VIII, and its identification number follows the CE marking. Category III PPE produced as a single unit for an individual user may follow the category II route instead.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 17(3), Art. 19, Annex V, points 6.1 and 7.4, Annex VII, point 4.2, and Annex VIII, point 4.3" }, { "q": "Which documents and information must accompany PPE, and in which language?", "a": "PPE must carry a type, batch or serial number and the manufacturer's and importer's name and postal address, and must be accompanied by the instructions and information of Annex II, point 1.4: storage, use, cleaning, maintenance and disinfection, the performance recorded in tests, accessories and spare parts, protection classes and limits of use, obsolescence, the meaning of markings, the risk protected against, the reference to the regulation, the notified body, the standards applied and the internet address of the EU declaration of conformity. The instructions must be in a language easily understood by end-users as determined by the Member State, and the declaration must either accompany the PPE or be reachable at the internet address given in the instructions. In Denmark, executive order nr. 210 requires the EU declaration of conformity and the instructions to be drawn up in or translated into Danish; since 30 May 2026 crisis-relevant PPE authorised under Article 41c must carry the 'crisis-relevant good' information in Danish or English (§ 5(2), inserted by executive order nr. 488 of 28 May 2026).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(5) to Art. 8(8), Art. 10(3), Art. 15(2) and Annex II, point 1.4; https://www.retsinformation.dk/eli/lta/2018/210 · § 5; https://www.retsinformation.dk/eli/lta/2026/488" }, { "q": "Are consumer products like sunglasses, gardening gloves or rain jackets covered?", "a": "It depends on the risk and the use. Eye protection against sunlight and gloves against superficial mechanical injury or weak cleaning materials protect against category I risks and are PPE, whether sold to professionals or consumers, so they need internal production control, an EU declaration of conformity and the CE marking. Clothing designed for private use against atmospheric conditions that are not extreme, and gloves for private use against damp and water during dishwashing, are excluded by Article 2(2), point (c); the same rain jacket designed for professional use is category I PPE.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 2(2), point (c), Art. 19, point (a), and Annex I, category I" }, { "q": "How long must I keep the technical documentation and traceability records?", "a": "Manufacturers keep the technical documentation and the EU declaration of conformity for 10 years after the PPE was placed on the market, authorised representatives keep both at the disposal of the authorities for the same period, and importers keep a copy of the declaration for 10 years and ensure the documentation can be produced. Manufacturers using module C2 also keep the notified body's test reports for 10 years. All economic operators must be able to identify who supplied them and whom they supplied for 10 years after each supply.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 8(3), Art. 9(2), Art. 10(8), Art. 13 and Annex VII, point 5.2" }, { "q": "Who enforces the PPE Regulation in Denmark?", "a": "Sikkerhedsstyrelsen took over the control of PPE products placed on the market from Arbejdstilsynet on 1 December 2018 and has been part of Erhvervsstyrelsen, the Danish Business Authority, as its Markedsovervågning department since January 2026; it acts under the Danish product act, which lists the PPE Regulation among the product regulations it enforces. Arbejdstilsynet remains the authority for the use of PPE at work and for the market surveillance of PPE made to order or imported from third countries for offshore oil and gas activities under the offshore safety act.", "source": "https://www.sik.dk/erhverv/produkter/personlige-vaernemidler/love-og-regler/regler-personlige-vaernemidler; https://www.retsinformation.dk/eli/lta/2026/22 · § 2, stk. 1, nr. 40, and § 9" } ], "changelog": [ { "date": "2026-09-11", "kind": "guidance", "title": "Guide rebuilt from the consolidated text of 29 May 2026", "summary": "The body was rewritten from the consolidated text with an article reference per fact. Corrections to the earlier guide: the exact lists of category I and category III risks and the five Article 2(2) exclusions replace the earlier examples; the transitional end dates of 21 April 2019 and 21 April 2023 are added; the Danish authority is now Erhvervsstyrelsen (Sikkerhedsstyrelsen became its Markedsovervågning department in January 2026) with Arbejdstilsynet named for the use of PPE; the emergency procedures of Regulation (EU) 2024/2748 are added.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0425-20260529 · Art. 2(2), Art. 47 and Annex I; https://www.sik.dk/erhverv/produkter/personlige-vaernemidler/love-og-regler/regler-personlige-vaernemidler" }, { "date": "2026-05-29", "kind": "applies", "title": "Emergency procedures for crisis-relevant PPE apply", "summary": "Regulation (EU) 2024/2748 applies: Articles 41a to 41e allow notified bodies to prioritise crisis-relevant PPE, Member States to authorise placing such PPE on the market without the mandatory notified-body procedure and without the CE marking, a presumption of conformity based on standards and common specifications listed by implementing act, and prioritised market surveillance, only while an internal market emergency mode under Regulation (EU) 2024/2747 is active and the Commission has activated the procedures for PPE.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R2748 · Art. 7; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0425-20260529 · Art. 41a" }, { "date": "2025-04-22", "kind": "amendment", "title": "Corrigendum to Regulation (EU) 2024/2748 published", "summary": "The corrigendum published in the Official Journal of 22 April 2025 corrects the second subparagraph of Article 41a(3): the provision that continues to apply after the emergency mode expires or is deactivated is Article 41c(7), under which nationally authorised PPE does not bear the CE marking, not Article 41d(7).", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0425-20260529 · Art. 41a(3), second subparagraph (C1)" }, { "date": "2024-11-28", "kind": "amendment", "title": "Regulation (EU) 2024/2748 in force: internal market emergency procedures", "summary": "The amending regulation of 9 October 2024, published on 8 November 2024, adds the definitions of crisis-relevant goods and internal market emergency mode as Article 3, points (19) and (20), and inserts Chapter VIa (Articles 41a to 41e); it applies from 29 May 2026.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R2748 · Art. 3 and Art. 7" }, { "date": "2023-04-21", "kind": "applies", "title": "Old-directive certificates expire; reclassification power tacitly extended", "summary": "EC type-examination certificates and approval decisions issued under Directive 89/686/EEC cease to be valid unless they expired earlier, so that all PPE on the market must now rest on assessments under the regulation; the Commission's five-year power, counted from 21 April 2018, to move a risk between the Annex I categories by delegated act is tacitly extended for a further five years.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 43(2) and Art. 47(2)" }, { "date": "2019-04-21", "kind": "applies", "title": "Transitional period for products under Directive 89/686/EEC ends", "summary": "From this date Member States are no longer required to accept the making available of PPE that conforms only to Directive 89/686/EEC; products placed on the market before 21 April 2019 under the old directive may still be made available.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 47(1)" }, { "date": "2018-12-01", "kind": "guidance", "title": "Sikkerhedsstyrelsen takes over control of PPE products in Denmark", "summary": "Sikkerhedsstyrelsen took over from Arbejdstilsynet the control of products to be used as PPE; Arbejdstilsynet remains the authority for the use of PPE and for the market surveillance of made-to-order or third-country PPE for offshore oil and gas activities. Since January 2026 Sikkerhedsstyrelsen is the Markedsovervågning department of Erhvervsstyrelsen.", "source": "https://www.sik.dk/erhverv/produkter/personlige-vaernemidler/love-og-regler/regler-personlige-vaernemidler; https://www.sik.dk/sikkerhedsstyrelsen-del-erhvervsstyrelsen" }, { "date": "2018-04-21", "kind": "applies", "title": "PPE Regulation applies; Directive 89/686/EEC repealed", "summary": "The regulation applies in full and Directive 89/686/EEC is repealed, references to it being read as references to the regulation per the Annex X correlation table; the Danish executive order nr. 210 of 14 March 2018 on supplementary requirements, including Danish-language declarations and instructions, enters into force the same day.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 46 and Art. 48(2); https://www.retsinformation.dk/eli/lta/2018/210 · § 10" }, { "date": "2016-10-21", "kind": "applies", "title": "Notified-body provisions apply", "summary": "Articles 20 to 36 on the notification, requirements and obligations of conformity assessment bodies and Article 44 on the committee procedure apply eighteen months ahead of the rest of the regulation.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 48(2), point (a)" }, { "date": "2016-04-20", "kind": "in-force", "title": "Regulation (EU) 2016/425 enters into force", "summary": "Adopted on 9 March 2016 and published in OJ L 81 on 31 March 2016, the regulation entered into force on the twentieth day after publication, with general application deferred to 21 April 2018.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425 · Art. 48" } ], "radar": [ { "date": "2026-06-16", "title": "New harmonised standards for personal protective equipment published (Implementing Decision (EU) 2026/1279)", "summary": "Commission Implementing Decision (EU) 2026/1279 of 12 June 2026 updates the list of harmonised standards giving a presumption of conformity for personal protective equipment under Regulation (EU) 2016/425, and repeals the previous Implementing Decision (EU) 2023/941. PPE manufacturers should align with the newly referenced and amended standards to maintain conformity assessment and CE marking.", "source": "https://eur-lex.europa.eu/eli/dec_impl/2026/1279/oj", "sourceName": "EUR-Lex" } ], "sources": [ { "label": "Regulation (EU) 2016/425 on personal protective equipment, consolidated text of 29 May 2026 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02016R0425-20260529" }, { "label": "Regulation (EU) 2016/425 as published in OJ L 81, 31 March 2016 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0425" }, { "label": "Document information, dates and relationships for CELEX 32016R0425 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32016R0425" }, { "label": "Regulation (EU) 2024/2748 on emergency procedures for the conformity assessment, presumption of conformity, common specifications and market surveillance of products (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R2748" }, { "label": "Personal protective equipment (PPE), with the PPE Regulation Guidelines, 5th edition, October 2025 (European Commission, DG GROW)", "url": "https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/personal-protective-equipment-ppe_en" }, { "label": "Regler for personlige værnemidler (Sikkerhedsstyrelsen, Erhvervsstyrelsen)", "url": "https://www.sik.dk/erhverv/produkter/personlige-vaernemidler/love-og-regler/regler-personlige-vaernemidler" }, { "label": "Kontrol med personlige værnemidler (Sikkerhedsstyrelsen, Erhvervsstyrelsen)", "url": "https://www.sik.dk/erhverv/produkter/personlige-vaernemidler/vejledninger/kontrol-personlige-vaernemidler" }, { "label": "Sikkerhedsstyrelsen, en del af Erhvervsstyrelsen from January 2026 (Sikkerhedsstyrelsen)", "url": "https://www.sik.dk/sikkerhedsstyrelsen-del-erhvervsstyrelsen" }, { "label": "Bekendtgørelse nr. 210 af 14. marts 2018 om indretning m.v. af personlige værnemidler (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2018/210" }, { "label": "Bekendtgørelse nr. 488 af 28. maj 2026 om ændring af bekendtgørelse om indretning m.v. af personlige værnemidler (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2026/488" }, { "label": "Lov om produkter og markedsovervågning, lovbekendtgørelse nr. 22 af 8. januar 2026 (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2026/22" } ], "reviewer": { "name": "Conphora compliance team", "role": "Compliance editors, Conphora" }, "reviewedAt": "2026-09-24", "nextReview": "2027-03-14", "links": { "tools": [], "courses": [], "related": { "en": "/regulations/ppe/", "dk": "/dk/eu-regulativer/ppe/" } } }