EU MDR (Regulation (EU) 2017/745): Scope, Structure, Key Obligations and Deadlines

It replaced two directives, has 123 articles plus Article 10a and 17 annexes, and has been amended by ten acts, three of which changed its dates.

The MDR governs the placing on the market, making available on the market and putting into service of medical devices for human use and their accessories in the Union, and clinical investigations conducted in the Union. It binds the economic operators, from manufacturers to distributors, as well as notified bodies, the member states and the Commission, and it applies directly, without national transposition.

This overview gives the identity of the act, its scope and exclusions, who it binds, the map of its 10 chapters and 17 annexes, the key obligations chapter by chapter, every application date with the legacy end dates and their conditions, the national rules it leaves open and its status as of 6 November 2026.

What Is the EU MDR?

The EU MDR (Medical Devices Regulation) is Regulation (EU) 2017/745, an act of the European Parliament and of the Council that sets the safety, performance and market rules for medical devices in the Union and replaced the two medical device directives of 1990 and 1993. Its purpose is a single set of rules for devices placed on the market or put into service in the Union: what counts as a device, who answers for it, how it is classified and assessed, what clinical evidence it needs and how it is watched once in use. The two directives it replaced are Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.

The MDR is a regulation, not a directive, so it is directly applicable in every member state and national law only fills the points it leaves to member states. One Medical Device Coordination Group (MDCG) and one European database, EUDAMED, serve both the MDR and the IVDR, Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Published in the same Official Journal issue as the IVDR, it is one half of the EU MDR and IVDR framework.

Identity: CELEX, Official Journal and Legal Basis

Regulation (EU) 2017/745 carries CELEX number 32017R0745 and was published in OJ L 117, 5.5.2017, p. 1. Its full title is "Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC". The Parliament and the Council adopted it on 5 April 2017 on the legal basis of Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union. The Commission proposal was COM(2012) 542, handled under procedure 2012/0266/COD, and the European Legislation Identifier of the act is http://data.europa.eu/eli/reg/2017/745/oj.

The authentic text, the one people look for as the "EU MDR PDF", is the version published in the Official Journal on EUR-Lex. Consolidated texts on EUR-Lex fold every amendment into one reading version, but they are a documentation tool with no legal effect; only the Official Journal versions are authentic. Two corrigenda followed in the Official Journal: OJ L 117, 3.5.2019, p. 9, and OJ L 334, 27.12.2019, p. 165.

How the Text Has Changed Since 2017

Ten acts have amended the MDR since 2017, and three of them changed its dates: Regulation (EU) 2020/561, Regulation (EU) 2023/607 and Regulation (EU) 2024/1860. Regulation (EU) 2020/561, adopted on 23 April 2020 and in force since its publication on 24 April 2020 (OJ L 130, 24.4.2020, p. 18), moved the date of application from 26 May 2020 to 26 May 2021 and made the Union-wide derogations of Article 59 applicable from 24 April 2020. It amended the MDR only; the IVDR kept its own date of application.

Regulation (EU) 2023/607, adopted on 15 March 2023 and in force since 20 March 2023 (OJ L 80, 20.3.2023, p. 24), replaced the legacy end date with 31 December 2027 and 31 December 2028, tied both to conditions and deleted the sell-off date. Regulation (EU) 2024/1860, adopted on 13 June 2024 and in force since its publication on 9 July 2024 (OJ L, 2024/1860, 9.7.2024), amended both regulations: it inserted Article 10a on supply interruption and made EUDAMED mandatory module by module instead of all at once.

The other seven amending acts are Delegated Regulations (EU) 2023/502, 2023/2197, 2025/788, 2026/1359 and 2026/1451 and Regulations (EU) 2024/568 and 2025/2457. A further act, Delegated Regulation (EU) 2025/1920, applies from 1 November 2028. Each act with its subject and date is listed on the amendments page in the table of MDR topics below.

Scope: Which Products the MDR Covers

MDR Article 1(1) applies the Regulation to placing on the market, making available on the market and putting into service of medical devices for human use and their accessories in the Union, and to clinical investigations conducted in the Union. The scope therefore has two triggers: a market act in the Union (placing, making available or putting into service) and a clinical investigation run in the Union. The three subsections below set out what Article 1 brings in, what Article 1(6) keeps out, and how products with two purposes or with an integral IVD are treated.

What Article 1 Brings into Scope

MDR Article 1(4) calls medical devices, accessories and the Annex XVI products together "devices", so the obligations that name "devices" reach all three. A medical device under MDR Article 2(1) is an instrument, apparatus, appliance, software, implant, reagent, material or other article that the manufacturer intends for human beings for specific medical purposes, such as diagnosis, prevention, monitoring, prediction or prognosis of disease. The full wording is explained under what a medical device is under the MDR.

Article 1(2) extends the Regulation to the products without an intended medical purpose listed in Annex XVI, which names six groups, and ties their regulation to common specifications. The Court of Justice of the European Union drew one boundary of the definition in case C-427/24 Diagramm Halbach: in its judgment of 2 July 2026 (Sixth Chamber, ECLI:EU:C:2026:535), it held that patient identification wristbands supplied completely blank are not medical devices within MDR Article 2(1) and (12).

What Article 1(6) Excludes

MDR Article 1(6) lists nine groups of products the Regulation does not apply to, points (a) to (i). The nine exclusions are listed below in the order of the article.

• In vitro diagnostic medical devices covered by Regulation (EU) 2017/746 (point (a)).
• Medicinal products (point (b)).
• Advanced therapy medicinal products (point (c)).
• Human blood, blood products, plasma and blood cells (point (d)).
• Cosmetic products (point (e)).
• Animal tissues or cells, except non-viable derivatives (point (f)).
• Human tissues or cells covered by Directive 2004/23/EC, except non-viable derivatives (point (g)).
• Viable biological material or viable organisms (point (h)).
• Food (point (i)).

The Court of Justice touched point (b) in case C-451/24 Kwizda Pharma (judgment of 4 September 2025, Ninth Chamber, ECLI:EU:C:2025:663): the reference was made in connection with MDR Article 1(6)(b), and the ruling interprets the rule of precedence in Article 2(2) of Directive 2001/83/EC. Point (a) draws the line between the two device regulations, and IVDs follow the IVDR (Regulation (EU) 2017/746) instead.

Combined and Dual-Purpose Products

A product with both a medical and a non-medical intended purpose must meet the requirements for both purposes cumulatively (MDR Article 1(3)). Both sets of requirements apply to the same product at the same time, and meeting one set does not satisfy the other.

A device that incorporates an in vitro diagnostic medical device as an integral part is governed by the MDR, while the IVD part meets the IVDR (MDR Article 1(7)). For medicinal products that incorporate an integral device, MDR Article 117 amended Annex I of Directive 2001/83/EC.

Who the MDR Binds

The MDR binds the economic operators (manufacturers, authorised representatives, importers, distributors and the producers of systems and procedure packs), the notified bodies, the member states and their competent authorities, the Commission and, for in-house devices, health institutions. MDR Article 2(35) defines the economic operator as a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3), which covers producers of systems and procedure packs. The manufacturer under MDR Article 2(30) is the natural or legal person who manufactures or fully refurbishes a device, or has it designed, manufactured or fully refurbished, and markets it under its own name or trademark.

MDR Article 16 sets the cases in which importers, distributors or other persons take on the manufacturer's obligations, and it covers relabelling and repackaging. Health institutions that manufacture and use devices in-house rely on the exemption of MDR Article 5(5), under the conditions it sets. Sponsors of clinical investigations carry the duties of Chapter VI. Notified bodies assess conformity, and member states designate the competent authorities that supervise the market.

Within each company, MDR Article 15 requires named expertise in regulatory matters for manufacturers and authorised representatives. Micro and small enterprises need not employ that person in-house, provided the person is permanently and continuously at their disposal (MDR Article 15(2)). For each manufacturer and authorised representative, the role is the person responsible for regulatory compliance.

How the MDR Is Organised: 10 Chapters and 17 Annexes

The MDR has 10 chapters with Articles 1 to 123 plus Article 10a, and 17 annexes, Annexes I to XVII. The chapters carry the obligations and the procedures; the annexes carry the technical detail the articles refer to. The table lists each chapter with its article range, its subject and the page that covers it.

The 17 annexes are listed below with their headings and the page that covers each.

Article 2 holds 71 definitions, from "medical device" to the terms of clinical evidence and market surveillance. Annex VIII sets 22 classification rules, and Annex XVII is the correlation table between the articles of the two repealed directives and the articles of the MDR.

MDR Topics in Detail: Transition, Legacy Devices, Classification, Conformity Assessment and Amendments

Five pages carry what this overview only summarises: the legacy end dates and their conditions, the duties that apply to legacy devices now, the 22 classification rules, the conformity assessment routes, and every amending act with the pending proposal. Each page answers one question with its legal hook in the MDR, as the table shows.

Key Obligations Chapter by Chapter

The obligations of the MDR sit in Chapters II to VII, and Chapters VIII to X set up the governance, national powers and final provisions around them. Chapter II says who answers for a device, Chapter III how it is identified and registered, Chapters IV and V who assesses it and by which route, Chapter VI what clinical evidence it needs, and Chapter VII what happens once it is in use. The six subsections below follow the chapter order of the Regulation.

Chapter II: Devices on the Market and Who Answers for Them

Chapter II (Articles 5 to 24) sets the conditions for placing devices on the market and putting them into service and the duties of each economic operator. MDR Article 5 sets those conditions, with the health institution exemption in Article 5(5). Article 6 covers devices offered by information society services (distance sales), and Article 7 prohibits misleading claims in labelling, instructions for use and advertising.

The operator duties follow in sequence. Article 10 sets the general obligations of manufacturers, among them risk management, clinical evaluation, technical documentation, a quality management system, post-market surveillance and liability cover. Articles 11 and 12 cover the authorised representative of non-EU manufacturers and its change, Article 13 importers, Article 14 distributors, Article 15 the person responsible for regulatory compliance, Article 16 the shift of manufacturer obligations, Article 17 the reprocessing of single-use devices as a national choice, and Article 18 the implant card. Articles 19 and 20 cover the EU declaration of conformity and the CE marking, Article 21 investigational and custom-made devices, Article 22 systems and procedure packs, Article 23 parts and components, and Article 24 free movement: member states may not restrict compliant devices. Under Article 21(3), devices that do not comply may be shown at trade fairs with a visible sign that they cannot be made available until they comply.

Article 10a, inserted by Regulation (EU) 2024/1860, has applied since 10 January 2025. A manufacturer that expects to interrupt or discontinue the supply of certain devices gives notice at least 6 months before the interruption, and the duty applies to legacy devices too. Which devices are covered and who must be told is set out under supply interruption under Article 10a.

Chapter III: Identification, Registration and the Database

Chapter III (Articles 25 to 34) covers supply-chain identification, the nomenclature, the UDI system, the registration of devices and of manufacturers, authorised representatives and importers, the summary of safety and clinical performance, and EUDAMED. Article 25 requires identification of economic operators within the supply chain, Article 26 provides the medical devices nomenclature free of charge, Articles 27 and 28 set the UDI system and the UDI database, Article 29 device registration, Article 30 the electronic system for registering economic operators, and Article 31 the registration of manufacturers, authorised representatives and importers, each of which receives a single registration number (SRN). Article 32 requires the summary of safety and clinical performance and has applied since 28 May 2026, and Articles 33 and 34 set up EUDAMED and its functionality audit.

EUDAMED has seven electronic systems grouped in six modules. As of 6 November 2026, four modules have been mandatory to use since 28 May 2026: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. That date follows from Commission Decision (EU) 2025/2371, the notice published on 27 November 2025, with the obligations applying 6 months later. The vigilance and clinical investigation modules are not mandatory. Two catch-up periods run from the publication of the notice, as listed below.

• Devices already on the market: registered within 12 months (MDR Article 123(3)(e)).
• Certificates issued by notified bodies: entered within 18 months (MDR Article 123(3)(ea)).

Chapters IV and V: Third-Party Assessment and Risk Ranking

Chapter IV (Articles 35 to 50) sets how member states designate and monitor notified bodies, and Chapter V (Articles 51 to 60) sets classification and conformity assessment. Chapter IV applied early, from 26 November 2017, three and a half years before the date of application. Each notified body undergoes a complete re-assessment every 5 years (MDR Article 44(10) as amended by Delegated Regulation (EU) 2023/502, in force since 11 March 2023). Implementing Regulation (EU) 2026/977 on uniform requirements for notified bodies applies from 25 February 2027; it is an implementing act, not an amendment of the MDR.

Chapter V ranks devices by risk. MDR Article 51 sets classes I, IIa, IIb and III under the 22 rules of Annex VIII, and Article 52(7) adds the class I sub-types Is, Im and Ir. Article 51 also covers disputes about the classification of a device. Article 52 assigns the conformity assessment routes of Annexes IX, X and XI by class, and Article 53 sets when a notified body is involved. Certificates are valid for at most 5 years and can be renewed (MDR Article 56(2)). Article 59 allows national and Union derogations from conformity assessment, and Article 60 provides a certificate of free sale for export.

Two procedures add expert review for certain class III and class IIb devices. MDR Article 54 sets the clinical evaluation consultation procedure, and MDR Article 55 the scrutiny mechanism for the conformity assessments of those devices. The consultation procedure covers class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product (MDR Article 54(1)). The opinions come from the expert panels under the MDR and IVDR.

Chapter VI: Clinical Evidence and Studies on Humans

Chapter VI (Articles 61 to 82) requires a clinical evaluation for every device under Article 61 and sets the rules for clinical investigations in Articles 62 to 82. The clinical evaluation rests on clinical data that give sufficient clinical evidence, and the manufacturer specifies and justifies the level of evidence for its device, whatever the class (MDR Article 61(1)). Article 61 also governs equivalence and the cases in which a clinical investigation is not required.

Annex XIV sets out the clinical evaluation and post-market clinical follow-up, and Annex XV the clinical investigations themselves. Delegated Regulation (EU) 2026/1451, in force since 19 July 2026, extended the list of devices under MDR Article 61(6)(b) for which a clinical investigation is not required; it leaves the clinical evaluation obligation in place. Articles 62 to 82 set the general requirements for clinical investigations conducted to demonstrate conformity and the duties of their sponsors, from the application to the final report.

Chapter VII: Duties Once Devices Are in Use

Chapter VII (Articles 83 to 100) obliges manufacturers to run post-market surveillance, report serious incidents and field safety corrective actions, and gives competent authorities market surveillance powers. MDR Articles 83 and 84 require a post-market surveillance system and plan, with the plan set out in Annex III. Article 85 requires a post-market surveillance report for class I devices, and Article 86(1) a periodic safety update report: for class IIa when necessary and at least every two years, for class IIb and class III at least annually.

Vigilance follows in Articles 87 to 92. Serious incidents are reported within 15 days in general, 2 days for a serious public health threat and 10 days for a death or an unanticipated serious deterioration in health (MDR Article 87). Article 92 sets up the electronic system on vigilance and on post-market surveillance, and Articles 93 to 100 set the market surveillance activities of competent authorities and the electronic system on market surveillance (Article 100). The reporting clock is explained under vigilance under the MDR and IVDR.

Chapters VIII to X: Governance, Penalties and Final Provisions

Chapter VIII (Articles 101 to 108) sets up the competent authorities, their cooperation, the Medical Device Coordination Group, expert panels and laboratories, and device registers. Member states designate their competent authorities under MDR Article 101, and MDR Article 103 establishes the MDCG, which serves both regulations. MDCG guidance is not legally binding (MDR Articles 103 and 105), although notified bodies take it into account. Competent authorities cooperate with each other under Article 102, the Commission supports the MDCG under Article 104, and Article 105 lists the MDCG tasks. Article 106 provides for expert panels and expert laboratories, Article 107 addresses conflicts of interests in those bodies, and Article 108 provides for device registers and databanks.

Chapter IX (Articles 109 to 113) covers confidentiality (Article 109), data protection (Article 110), national fees (Article 111), the funding of notified-body designation and monitoring (Article 112) and penalties (Article 113). Chapter X (Articles 114 to 123) holds the final provisions: the committee procedure and delegated acts (Articles 114 to 116), the amendments to Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (Articles 117 to 119), the transitional provisions (Article 120), the evaluation (Article 121), the repeal (Article 122) and the entry into force and application (Article 123).

Application Dates from 2017 to 2028

The MDR entered into force on 25 May 2017 and has applied since 26 May 2021, one year later than first planned because Regulation (EU) 2020/561 moved the date from 26 May 2020 (MDR Article 123(2)). Entry into force was the 20th day after publication on 5 May 2017 (MDR Article 123(1)). Other provisions applied earlier or apply later, so the MDR has a sequence of dates rather than one. The table lists the 11 rows of that sequence with the article that sets each date.

Legacy end dates apply only where the Article 120(3c) conditions are met; the condition list is on the MDR transition period page.

Dates That Still Lie Ahead

As of 6 November 2026, the next fixed dates are 26 May 2027 for direct UDI marking of reusable class I devices (MDR Article 123(3)(g)(iii)) and 27 May 2027 for the Commission evaluation report (MDR Article 121).

The legacy end dates follow. Legacy devices may be placed on the market or put into service until 31 December 2027 for class III and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, and until 31 December 2028 for all other legacy devices (MDR Article 120(3a) and (3b) as amended by Regulation (EU) 2023/607). Both dates apply only under the conditions of MDR Article 120(3c), which include a quality management system and a formal application to a notified body by 26 May 2024 and a written agreement by 26 September 2024. No sell-off date limits the making available of units already placed on the market (MDR Article 120(4)). The period for class III custom-made implantable devices under MDR Article 120(3f) ended on 26 May 2026.

The Directives the MDR Replaced

The MDR repealed Council Directive 93/42/EEC on medical devices (MDD) and Council Directive 90/385/EEC on active implantable medical devices (AIMDD) with effect from 26 May 2021 (MDR Article 122), with the exceptions listed in that article. The MDD dates from 14 June 1993 (OJ L 169, 12.7.1993) and the AIMDD from 20 June 1990 (OJ L 189, 20.7.1990); EUR-Lex records 25 May 2021 as the end of validity of both. The differences are compared under MDD vs MDR.

The directives remain the reference for legacy devices: devices with a certificate under the MDD or the AIMDD, and devices self-declared under the MDD that now need a notified body, still placed on the market under MDR Article 120. They also explain two numbers that still circulate. The MDD had 18 classification rules in its Annex IX, a count that is history; the MDR has 22. The original MDR date of application, 26 May 2020, is history too, because Regulation (EU) 2020/561 replaced it before it arrived.

National Rules Next to a Directly Applicable Regulation

The MDR applies without transposition, so national laws only implement what it leaves to member states: penalties, fees, languages, distributor registration, reprocessing and in-house rules. Member states lay down the penalties under MDR Article 113 and notified their penalty rules by 25 February 2021. They may levy fees under MDR Article 111, and MDR Article 30(2) permits national registration of distributors, who do not register in EUDAMED. Language requirements for labels and instructions are national; the Commission MDR language table, Rev. 3 of August 2025, summarises them, and national provisions take precedence over the table. MDR Article 17 leaves the reprocessing of single-use devices to a national choice, and in-house rules for health institutions, built on MDR Article 5(5), are national too.

Germany shows the pattern. Its implementing act is the Medizinprodukterecht-Durchführungsgesetz (MPDG, Medical Devices Law Implementation Act) of 28 April 2020, BGBl. I S. 960, which implements both the MDR and the IVDR. The German rules are set out under MDR and IVDR in Germany.

MDR Status Summary as of 2026-11-06

As of 6 November 2026, the MDR applies in full, the legacy periods run to 31 December 2027 or 31 December 2028 for legacy devices that meet the Article 120(3c) conditions, four EUDAMED modules are mandatory, and a targeted revision is pending. In 2026, mandatory use of four EUDAMED modules began on 28 May, with catch-up periods that run from the notice (see the Chapter III section above). Still pending are the vigilance and clinical investigation modules, the dates in the section on dates that still lie ahead, and the revision.

The revision is pending: Commission proposal COM(2025) 1023 of 16 December 2025, procedure 2025/0404(COD), is at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026, and it is not law. The past procedural events in the OEIL procedure file include the draft report of 30 June 2026 and the amendments of 28 July 2026. The proposal would remove the five-year cap on certificate validity, and it does not change the 2027 and 2028 legacy end dates.

Case law moved in 2026 as well. The Court of Justice ruled in case C-10/24 Dürr Dental v Cattani on 4 June 2026 on the due care that MDR Article 14 asks of distributors. A distributor verifies that the CE marking and the declaration of conformity clearly concern a device within the MDR, but it has no duty to verify a class IIa classification.

Where the MDR Stops

The MDR governs devices placed on the market or put into service in the Union: it provides no single MDR certificate, it excludes IVDs under Article 1(6)(a), and it applies as a Union act in the member states. Four questions sit at that edge: territory, tests on human specimens, who checks conformity, and how a quality standard relates to the Regulation.

Does the EU MDR Apply Outside the EU?

The MDR is a regulation of the European Union and applies directly in its member states. A manufacturer established outside the Union is still bound when it places devices on the Union market, and it acts through an authorised representative under MDR Article 11. The rules for Great Britain and Northern Ireland are set out under medical device rules in the United Kingdom.

Does the EU MDR Apply to Tests on Human Specimens?

No: in vitro diagnostic medical devices covered by Regulation (EU) 2017/746 are excluded from the MDR by Article 1(6)(a), and the IVDR has applied since 26 May 2022. The IVDR was published in the same Official Journal issue (OJ L 117, 5.5.2017, p. 176). Where a device incorporates an IVD as an integral part, the MDR governs the device and the IVD part meets the IVDR (MDR Article 1(7)).

Who Checks Conformity If There Is No Central Agency?

The EU has no central device regulator: the manufacturer declares conformity, a notified body assesses it where the class requires one, and national competent authorities supervise the market. The EU has no equivalent of the US Food and Drug Administration. "EU MDR certification" is therefore not one document: there is no single MDR certificate, only the manufacturer's EU declaration of conformity and, where the class requires a notified body, its certificates. Where a notified body was involved, its four-digit number appears next to the CE marking (MDR Article 20(5)).

How Does a Quality Standard Relate to the MDR?

A harmonised standard gives a presumption of conformity under MDR Article 8 only when its reference is listed in Implementing Decision (EU) 2021/1182, as amended. EN ISO 13485:2016 with its corrigendum AC:2018 and amendment A11:2021 has been entry 10 of that list since 5 January 2022. An ISO 13485 certificate from a certification body is not an MDR certificate. The current list is kept under harmonised standards under the MDR and IVDR.