Regulation (EU) 2017/745, the EU Medical Device Regulation or MDR, is the legal framework that governs how medical devices are designed, classified, evaluated, registered and surveilled across the EU 27, the European Economic Area and Northern Ireland. It replaced the 1993 Medical Device Directive (93/42/EEC) and the 1990 Active Implantable Medical Devices Directive (90/385/EEC) on 26 May 2021. The scope is set in MDR Article 1 and elaborated by the European Commission on its new-regulations portal.
This page is written for in-house regulatory affairs at medical-device manufacturers and the consultants who support them. It covers what changed versus the MDD, the device classes and conformity routes, the staggered transition deadlines, the obligations every manufacturer carries, how MDR and IVDR differ for mixed portfolios, and where EUDAMED registration fits inside the broader compliance picture.
What MDR 2017/745 is and why it replaced the MDD
The European Parliament and the Council adopted Regulation (EU) 2017/745 on 5 April 2017 and published it in the Official Journal as part of OJ L 117 on 5 May 2017. The regulation entered into force twenty days after publication, on 25 May 2017, and its date of application was set three years later. That application date moved once: under Regulation (EU) 2020/561, enacted during the early COVID-19 disruption, the Commission postponed the MDR’s date of application by twelve months to 26 May 2021. From that date, the MDR replaced two directives that had governed the EU device sector since the 1990s: the Medical Device Directive (93/42/EEC, MDD) and the Active Implantable Medical Devices Directive (90/385/EEC, AIMDD). The Commission has continued to refine the framework through implementing acts and, in December 2025, opened a simplification proposal aimed at the operational burden the sector has reported through the transition.
Scope is set out in Article 1 of the MDR. The regulation covers medical devices, their accessories, and a list of products without an intended medical purpose set out in Annex XVI (coloured contact lenses, certain dermal fillers, equipment for liposuction and similar groups the Commission has brought into scope through common specifications). The MDR applies in the 27 EU Member States, in Iceland, Liechtenstein and Norway under the EEA Agreement, and in Northern Ireland under the Windsor Framework. The European Commission maintains the canonical reading list on its new-regulations portal, and EUR-Lex hosts the consolidated text updated to reflect each amending instrument.
What changes vs the MDD: stricter clinical evidence, PMS, UDI, Notified Body oversight, expanded scope
The MDR keeps the directive-era architecture (CE marking, conformity assessment routed through Notified Bodies for higher-risk classes) but tightens the requirements that surround it on five fronts.
Clinical evaluation under Article 61 and Annex XIV raises the evidence floor. Equivalence claims to existing devices, the workhorse of MDD-era technical files, are harder to defend; clinical investigations under Articles 62 to 82 carry stricter requirements; post-market clinical follow-up under Annex XIV Part B is a continuing obligation rather than a one-time exercise.
Post-market surveillance under Articles 83 to 86 formalises a PMS system every manufacturer maintains throughout the device lifecycle. Class IIa and above publish a Periodic Safety Update Report under Article 86, updated annually for Class III and implantable devices and at least every two years for Class IIb. Class I devices produce a PMS report under Article 85.
UDI under Article 27 attaches a Basic UDI-DI (device-family identifier) and a UDI-DI (device-version identifier) to every device, assigned by one of the four issuing entities the Commission has designated (GS1, HIBCC, IFA, ICCBBA). The MDD had no comparable system.
Notified Body designation under Annex VII was re-done under stricter criteria, and the Commission’s NANDO database lists each Notified Body’s current MDR scope. Annex XVI brought products without an intended medical purpose into scope for the first time. Article 10 restates the manufacturer’s general obligations; Article 11 requires non-EU manufacturers to appoint an EU authorised representative; Articles 13 and 14 cover importers and distributors.
| Topic | MDD position | MDR position |
|---|---|---|
| Clinical evidence | Equivalence claims widely accepted; one-time evaluation common | Equivalence harder to defend; PMCF continuous; Article 61 + Annex XIV Parts A and B |
| Post-market surveillance | Lightly specified | PSUR or PMS report by class under Articles 83 to 86 |
| UDI traceability | Not required | UDI carrier required on devices and outer packaging under Article 27 |
| Notified Body oversight | Designations under the directive; lighter audit regime | Re-designation under stricter criteria; unannounced audits codified; NANDO lists MDR scope |
| Scope of products | Medical devices and AIMDs only | Adds Annex XVI products without medical purpose |
Device classes I, IIa, IIb, III and conformity assessment routes
Every device under the MDR is classified into one of four risk classes through the 22 rules in Annex VIII. Class I carries the lightest oversight; Class III the highest. Within Class I, three sub-classes attract Notified Body involvement for the relevant attribute only: Is (sterile), Im (measuring function) and Ir (reusable surgical instruments).
Rule 11 in Annex VIII changed software classification materially. Software intended to provide information used in decisions for diagnosis or therapeutic purposes is at least Class IIa, with higher classification where the decision can cause death or serious deterioration of health. Many decision-support and standalone diagnostic software products that were Class I under the MDD moved up to Class IIa, IIb or III.
Conformity assessment routes sit in three annexes: Annex IX (full QMS plus technical-documentation assessment, the route most Class IIa, IIb and III manufacturers take), Annex X (type examination), and Annex XI (product conformity verification or production quality assurance). Annex XIII covers custom-made devices, including the Class III custom-made implantables that have their own transition deadline.
MDCG 2021-24 Rev. 1, updated in April 2026, is the working classification guidance for borderline class decisions.
| Class | Self-declaration possible? | Notified Body required? | Conformity route | Typical examples |
|---|---|---|---|---|
| Class I (non-sterile, non-measuring, non-reusable surgical) | Yes | No | Annex II and III dossier prepared; CE marking under manufacturer’s responsibility | Stethoscope, wheelchair, non-invasive examination glove |
| Class I sterile (Is), measuring (Im), reusable surgical (Ir) | No, for the relevant attribute | Yes, for that attribute only | Annex IX Chapter I or Annex XI Part A | Sterile drape (Is), reusable surgical scissors (Ir), thermometer (Im) |
| Class IIa | No | Yes | Annex IX Chapters I and III, or Annex XI | Hearing aid, dental filling, software providing diagnostic or therapeutic information (Rule 11) |
| Class IIb | No | Yes | Annex IX Chapters I and III, or Annex X with Annex XI Part A | Ventilator, anaesthesia machine, condom |
| Class III | No | Yes (with additional scrutiny for implantables) | Annex IX Chapters I, II and III, or Annex X with Annex XI Part A | Pacemaker, heart valve, breast implant |
Transition deadlines: 2024, 2026, 2027 and 2028
Article 120 of the MDR governs the transition from MDD and AIMDD to MDR. The original Article 120 set a single 26 May 2024 cutoff. Regulation (EU) 2023/607, adopted on 15 March 2023, replaced that single cutoff with a staggered set the device sector has been working to since.
The current dates are:
- 26 May 2024. Manufacturer must have a formal written agreement with a Notified Body for the relevant MDR conformity assessment. This is the milestone that opens the extended-transition path for the device.
- 26 May 2026. Class III custom-made implantable devices under Annex XIII no longer benefit from the extended transition. They require an MDR conformity assessment by this date to remain on the market.
- 31 December 2027. High-risk legacy devices stop benefiting from the extension. The bucket here covers Class III devices and Class IIb implantables placed on the market under the MDD before 26 May 2021.
- 31 December 2028. Medium-and-lower-risk legacy devices stop benefiting from the extension. The bucket covers Class IIb non-implantable devices, Class IIa devices, and the up-classification group (notably software under Rule 11 that moved from Class I under the MDD to Class IIa or higher under MDR).
To use the extended path, the manufacturer needs (a) the 26 May 2024 written agreement with a designated Notified Body, (b) continued compliance with the MDD requirements that applied at the time of placing on the market, and (c) no significant changes in design or intended purpose. The European Commission maintains a Q&A on the extended transition on its new-regulations portal that addresses the operational questions.
The IVDR side runs on its own schedule under Regulation (EU) 2024/1860, which also tightens the legacy-device EUDAMED entry mechanic. The MDR/IVDR split is covered later in this page.
Geographic scope: EU 27, EEA, Northern Ireland and how UK MDR 2002 differs
The MDR applies in the 27 EU Member States, the three EEA states (Iceland, Liechtenstein, Norway) and Northern Ireland under the Northern Ireland Protocol as updated by the Windsor Framework. A device placed on the market in any of these territories needs a valid CE mark issued under the MDR by a Notified Body designated under the MDR.
Great Britain (England, Scotland and Wales) sits outside the EU MDR. Devices placed on the GB market are regulated under the UK Medical Devices Regulations 2002, as amended, with UKCA marking and the Medicines and Healthcare products Regulatory Agency (MHRA) as the competent authority. The gov.uk guidance on regulating medical devices in the UK sets out the current rules and the transitional acceptance of CE-marked devices on the GB market.
Two consequences follow. A manufacturer selling into the EU market through Northern Ireland or through any of the EU 27 carries MDR obligations in full, including EUDAMED registration. A manufacturer selling into Great Britain operates under the UK system separately, with its own classification (broadly aligned with MDR for now) and no EUDAMED equivalent on the GB side.
A US-based or other non-EU manufacturer placing devices on any of the MDR territories needs an EU authorised representative under Article 11. The authorised representative is the regulatory contact point in the EU, shares Article 11 obligations with the manufacturer, and must be appointed before the first device is placed on the EU market.
Key obligations: clinical evidence, PMS, UDI, Notified Body, technical documentation
Five obligation bundles run through the MDR. Each is anchored to a specific Article or Annex; the operating consequence is the work the manufacturer’s RA function plans for the lifetime of the device.
Stricter clinical evidence (Article 61 and Annex XIV)
Clinical evaluation under Article 61 follows the process in Annex XIV Part A. Equivalence claims need full access to the equivalent device’s technical data, which in practice rules out off-label equivalence to a competitor product. Class III and implantable devices need a Summary of Safety and Clinical Performance under Article 32, published in EUDAMED. Post-market clinical follow-up under Annex XIV Part B is a continuing duty for every device, sized to risk class and clinical question.
Post-market surveillance (Articles 83 to 86)
The PMS system under Articles 83 to 86 is a documented, proactive, risk-based plan for gathering and acting on field data. The PSUR for Class IIa, IIb and III devices summarises the data, updated annually for Class III and implantables and at least every two years for Class IIb. The Class I PMS report is updated when necessary and available to the competent authority on request.
Unique Device Identification (Article 27)
The UDI system under Article 27 attaches a Basic UDI-DI (the device-family identifier registered in EUDAMED) and a UDI-DI (the device-version identifier on the device or its packaging) to every device. The four issuing entities the Commission has designated are GS1, HIBCC, IFA and ICCBBA. MDCG 2018-1 Rev. 4 is the working guidance on Basic UDI-DI assignment.
Notified Body oversight (Annex VII and NANDO)
Notified Bodies under the MDR are designated under Annex VII and listed in the European Commission’s NANDO database with their MDR scope. A manufacturer choosing a Notified Body confirms the body’s designation covers the relevant codes (MDA, MDN, MDS) and the procedures in Annexes IX, X or XI. The MDR also codifies unannounced audits at manufacturer and critical-supplier sites.
Technical documentation (Annex II and Annex III)
Annex II is the dossier covering device description, design and manufacturing information, evidence of General Safety and Performance Requirements (Annex I) compliance, risk-benefit analysis, and verification and validation. Annex III covers PMS-specific documentation. The Annex II content also seeds the device record in EUDAMED, which is where the field-by-field mapping becomes a working concern for the team preparing the registration.
MDR vs IVDR: how the regulations differ for organisations with both portfolios
The MDR is one half of the EU’s two-regulation reset; the other half is Regulation (EU) 2017/746, the IVDR. For a manufacturer with both portfolios the two are parallel rather than identical: same European Commission, same EUDAMED database, same Notified Body designation scheme through NANDO, distinct classification systems and distinct transition timetables.
The IVDR’s date of application was 26 May 2022. Regulation (EU) 2024/1860 extended the IVDR legacy-device transition for products with extended certificates, with cutoffs sequenced through 2027 and 2029 by class. Classification under IVDR Annex VIII uses seven rules and runs A, B, C, D: Class A IVDs are the lowest risk and broadly self-declared; Class D the highest.
| Topic | MDR | IVDR |
|---|---|---|
| Regulation number | (EU) 2017/745 | (EU) 2017/746 |
| Date of application | 26 May 2021 | 26 May 2022 |
| Device-type scope | Medical devices, accessories, Annex XVI products | In vitro diagnostic medical devices and accessories |
| Classification scheme | Class I, IIa, IIb, III | Class A, B, C, D |
| Classification basis | Annex VIII (22 rules) | Annex VIII (7 rules) |
| EUDAMED entry | UDI/Devices module, MDR device records | UDI/Devices module, IVDR device records (distinct entries) |
For the deeper read on how MDR and IVDR differ operationally for mixed portfolios, see the IVDR guide.
Where EUDAMED registration fits, and the relationship to ISO 13485
EUDAMED is the European Database on Medical Devices the European Commission operates under MDR Article 33. It is the registry for actor records (manufacturers, authorised representatives, importers, system or procedure-pack producers), device records (UDI/Devices module), Notified Bodies and certificates, vigilance, market surveillance, and clinical investigations. Mandatory use of the first four functional modules began on 28 May 2026, after Commission Decision (EU) 2025/2371 of 26 November 2025 started the transition periods running. For the operational walk-through, see EUDAMED registration for medical device manufacturers.
EUDAMED is distinct from ISO 13485. ISO 13485:2016 is the international standard for a medical-device quality management system. The MDR does not name ISO 13485 directly, but the conformity assessment route in Annex IX Chapter I requires a full QMS audited by the Notified Body, and the working convention is to build that QMS to ISO 13485:2016. For any manufacturer outside Class I (non-sterile, non-measuring, non-reusable surgical), ISO 13485 certification is the default route to demonstrating the QMS the Notified Body assesses.
The Person Responsible for Regulatory Compliance (PRRC) under Article 15 is the documented individual inside the manufacturer (or, for an SME, within the authorised representative or under a written arrangement) who holds named responsibility for conformity declarations, technical documentation, PMS and vigilance reporting. MDCG 2019-7 sets out the qualification requirements.
Read further
Three onward reads, sequenced by the question manufacturers most commonly hit next:
- Where EUDAMED registration fits under MDR. The next step in MDR compliance. Covers actor records, device records and the operating sequence the portal accepts.
- How MDR and IVDR differ. For manufacturers with both portfolios; the IVDR guide covers the diagnostic side in parallel.
- The 2027 and 2028 transition deadlines in detail. For manufacturers working out which devices fall into which bucket of MDR Article 120 as amended by Regulation (EU) 2023/607.
Read the regulation directly
- Consolidated text of Regulation (EU) 2017/745 on EUR-Lex. The MDR as it stands today, with each amending instrument folded in.
- Original publication in OJ L 117, 5 May 2017. The MDR as adopted, useful when reading earlier guidance that cites the original article numbering.
- The European Commission’s medical-devices new-regulations portal. The canonical reading list, Q&A and update notices.