Regulation (EU) 2017/745 (MDR) — key articles
The full text of MDR 2017/745 is available in the Official Journal of the EU: OJ L 117, 5.5.2017, p. 1–175. All article references on this site refer to the MDR as amended, including amendments made by Regulation (EU) 2020/561 and Regulation (EU) 2023/607.
This site provides article summaries for navigation purposes only. Always refer to the official consolidated text for legal compliance purposes.
Structure of the MDR
MDR 2017/745 contains 123 Articles organised into 10 Chapters, plus 17 Annexes:
| Chapter | Articles | Subject |
|---|---|---|
| I | 1–4 | Scope, definitions, regulatory status of products |
| II | 5–10 | Placing on market and putting into service; obligations of economic operators |
| III | 11–15 | Identification and traceability; registration; summary of safety and clinical performance |
| IV | 16–20 | Notified bodies |
| V | 21–35 | Classification and conformity assessment |
| VI | 36–50 | Clinical evaluation and clinical investigations |
| VII | 51–60 | Market surveillance; vigilance; market surveillance |
| VIII | 61–75 | Cooperation between member states; Medical Device Coordination Group |
| IX | 76–100 | Confidentiality, data protection, funding, penalties |
| X | 101–123 | Final provisions, repeal, transitional provisions |
Chapter I — Scope and definitions
Art. 1 — Scope
Defines what MDR applies to: medical devices, accessories to medical devices, and Annex XVI non-medical-purpose devices. Specifies what is excluded (medicinal products, food, cosmetics, etc.).
Art. 2 — Definitions
Contains 68 numbered definitions — the interpretive foundation of the entire regulation. Critical definitions include:
- Art. 2(1): Medical device
- Art. 2(2): Accessory to a medical device
- Art. 2(3): Custom-made device
- Art. 2(5): Implantable device
- Art. 2(8): Single-use device
- Art. 2(24): Intended purpose
- Art. 2(26): Manufacturer
- Art. 2(65): Serious incident
- Art. 2(68): FSCA
Art. 3 — Regulatory status of products
Procedure for determining whether a product falls under MDR or another regulatory framework (medicinal product, biocide, food).
Chapter II — Economic operators
Art. 5 — Placing on the market and putting into service
A device may only be placed on the EU market or put into service if it complies with MDR when duly supplied and properly maintained.
Art. 7 — Claims
Prohibitions on misleading, false, or unsubstantiated claims in labelling, IFU, and promotional materials.
Art. 9 — Common specifications
Empowers the Commission to adopt Common Specifications where no harmonised standard exists or is insufficient.
Art. 10 — General obligations of manufacturers
The comprehensive list of manufacturer obligations: QMS, technical documentation, conformity assessment, CE marking, EUDAMED registration, PMS, vigilance, cooperation with NCAs.
Art. 11 — Authorised representative
Obligations of the EU REP for non-EU manufacturers; joint and several liability.
Art. 13 — Obligations of importers
Verification before placing on market; labelling obligations; complaint handling; cooperation with recalls.
Art. 14 — Obligations of distributors
Verification before making available; cooperation with FSCAs; complaint handling.
Art. 16 — Cases where manufacturer obligations apply to importers/distributors
When an importer or distributor modifies a device or places it on the market under their own name, they become the manufacturer.
Art. 17 — Reprocessing of single-use devices
Framework for member states that permit reprocessing; reprocessor takes on manufacturer obligations.
Art. 18 — Implant card
Manufacturers of implantable devices must provide an implant card with each device.
Art. 19 — EU Declaration of Conformity
Requirements for the DoC; Annex IV specifies content.
Art. 20 — CE marking
Requirements for affixing the CE mark.
Chapter III — Identification, traceability, registration
Art. 27 — UDI system
UDI requirements for all devices; application timeline by class; EUDAMED registration of UDI.
Art. 28–31 — EUDAMED registration
Economic operator registration; device registration; notified body and certificate data; clinical investigation registration.
Art. 32 — Summary of Safety and Clinical Performance (SSCP)
Required for Class III and implantable devices; validated by NB; publicly accessible in EUDAMED.
Chapter IV — Notified bodies
Art. 36–39 — Designation of notified bodies
Requirements for NCA designation of NBs; assessment criteria; MDCG involvement.
Art. 40–44 — NB operations
Subsidiaries and subcontracting; changes in designation; challenge to NB competence.
Art. 45 — Coordination of notified bodies
Joint assessments; consistency across NBs.
Chapter V — Classification and conformity assessment
Art. 51 — Classification
Rules-based classification under Annex VIII; Commission power to reclassify.
Art. 52 — Conformity assessment procedures
Available routes by class; Annex IX, X, XI options; self-declaration for Class I.
Art. 54 — Special procedure for Class III and certain Class IIb
Expert panel consultation before NB can issue certificate for certain high-risk devices.
Art. 55 — Mechanism for scrutiny of conformity assessments
NCA or Commission can request NB to review an issued certificate.
Chapter VI — Clinical evaluation and investigations
Art. 61 — Clinical evaluation
Requirements for all classes; lifecycle approach; PMCF obligation; conditions for clinical investigations.
Art. 62–82 — Clinical investigations
Full framework for clinical investigations: regulatory requirements, ethics committee, NCA authorisation, GCP, reporting.
Chapter VII — Market surveillance and vigilance
Art. 83–86 — PMS system
PMS system, plan, PSUR, and report requirements.
Art. 87–92 — Vigilance
Serious incident reporting; FSCA notification; trend reporting; analysis by NCAs; European database.
Art. 93 — Market surveillance activities
NCA powers to investigate devices; unannounced inspections.
Art. 94 — Evaluation of devices suspected of presenting unacceptable risk
Procedure when an NCA identifies a potentially non-compliant or dangerous device.
Art. 95–97 — Corrective actions, safeguard, and EU-level measures
NCA corrective action powers; Commission safeguard procedure.
Chapter X — Transitional provisions
Art. 120 — Transitional provisions
Continued validity of MDD/AIMDD certificates; conditions for continued marketing during transition; sell-through provisions. As amended by Regulation (EU) 2023/607.
Art. 122 — Repeal
Repeal of Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD).
The 17 Annexes
| Annex | Content |
|---|---|
| I | General Safety and Performance Requirements (GSPR) |
| II | Technical documentation |
| III | Technical documentation on post-market surveillance |
| IV | EU Declaration of Conformity |
| V | CE marking |
| VI | Information to be submitted upon registration of devices and economic operators |
| VII | Requirements to be met by notified bodies |
| VIII | Classification rules |
| IX | Conformity assessment based on QMS and technical documentation |
| X | Conformity assessment based on type examination |
| XI | Conformity assessment based on product conformity verification |
| XII | Certificates issued by notified bodies |
| XIII | Procedure for custom-made devices |
| XIV | Clinical evaluation and PMCF |
| XV | Clinical investigations |
| XVI | List of groups of products without medical purpose |
| XVII | Correlation table (MDD/AIMDD to MDR) |
Related pages
- IVDR key articles
- MDR Annexes
- IVDR Annexes
- How to read EU legislation
- Recent amendments & corrigenda
Official references
| Reference | Description |
|---|---|
| OJ L 117, 5.5.2017 | MDR original publication |
| Regulation (EU) 2020/561 | Amendment — transitional dates |
| Regulation (EU) 2023/607 | Amendment — extended transitional provisions |
| EUR-Lex consolidated text | Current consolidated version of MDR |