- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- EU MDR 2017/745
What the MDR regulates
Article 2 defines a medical device as an instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer for a specific medical purpose, such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Accessories are covered too.
Annex XVI brings certain products without an intended medical purpose into scope, such as coloured contact lenses, some aesthetic implants and equipment for liposuction or skin treatments, once common specifications apply. In vitro diagnostic devices fall under a separate regulation, (EU) 2017/746 (IVDR).
Key dates
| Date | Event |
|---|---|
| 5 May 2017 | MDR published in the Official Journal of the EU |
| 25 May 2017 | MDR entered into force |
| 26 May 2021 | Date of application, after a one-year postponement adopted in 2020 |
| 26 May 2024 | Deadline for legacy devices to have an MDR QMS and an application lodged with a notified body to benefit from the extended transition |
| 31 December 2027 | End of transition for Class III and Class IIb implantable legacy devices (with exceptions) |
| 31 December 2028 | End of transition for other legacy devices that need a notified body |
What changed compared with the MDD
- Essential Requirements were replaced by the more detailed General Safety and Performance Requirements in Annex I.
- Technical documentation content is defined in Annexes II and III instead of being left largely to guidance.
- Clinical evidence requirements are stricter, especially for equivalence and for Class III and implantable devices.
- Post-market surveillance became a defined system with a PMS plan, PMS report or PSUR, and PMCF.
- Unique Device Identification (UDI) and the EUDAMED database were introduced.
- Each manufacturer needs a person responsible for regulatory compliance (Article 15).
- Some devices moved to a higher class, notably software under Rule 11 and substance-based devices under Rule 21.
Classification and conformity assessment
Annex VIII contains 22 classification rules grouped into non-invasive devices, invasive devices, active devices and special rules. The class decides the conformity assessment route under Article 52. Class I devices are self-certified by the manufacturer, except sterile (Is), measuring (Im) and reusable surgical (Ir) devices, where a notified body assesses the aspects concerned. Class IIa, IIb and III devices require a notified body, usually through the QMS and technical documentation assessment in Annex IX.
The MDCG guidance MDCG 2021-24 explains how the classification rules are applied and includes worked examples.
Who has obligations
| Actor | Main obligations |
|---|---|
| Manufacturer | Article 10: risk management, QMS, clinical evaluation, technical documentation, declaration of conformity, UDI, PMS, vigilance |
| Authorised representative | Article 11: acts for a non-EU manufacturer, verifies documentation, cooperates with authorities |
| Importer | Article 13: checks CE marking, declaration, labelling and registration before placing on the market |
| Distributor | Article 14: verifies labelling and conformity indications, reports complaints |
| Notified body | Assesses conformity for devices that need third-party assessment; listed in the Commission's NANDO database |
| Competent authority | Market surveillance and vigilance oversight in each Member State |
What MDR means for daily work
MDR is not a one-time certification project. Article 10 requires manufacturers to keep their documentation and systems up to date. In practice that means every change to the device, every new standard edition and every relevant post-market finding should be traced into the risk file, the clinical evaluation, the GSPR checklist and, where needed, the labelling. This is why many manufacturers move from folders to a connected workspace.
MDRpilot is one such workspace. It keeps the technical file, GSPR, risk, clinical, PMS and QMS records on one product record and shows open gaps. It does not perform conformity assessment or replace the notified body.
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- Regulation (EU) 2023/607 amending the MDR transitional provisions — EUR-Lex, Publications Office of the European Union.
- Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 — EUR-Lex, Publications Office of the European Union.
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) — EUR-Lex, Publications Office of the European Union.
- MDCG 2021-24 Guidance on classification of medical devices — Medical Device Coordination Group. Listed under classification.
- MDCG 2019-11 Qualification and classification of software (MDR and IVDR) — Medical Device Coordination Group. Listed under medical device software.
- Medical devices: new regulations — European Commission, Directorate-General for Health and Food Safety.
- NANDO: notified bodies database — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
This guide is general information about the regulation and standards named above. It is not legal or regulatory advice for a specific device.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.