RAPath EU
EU Medical Device Regulatory Reference — MDR & IVDR
RAPath EU is a plain English reference for EU medical device regulation under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It is designed for regulatory affairs professionals, manufacturers, importers, EU authorised representatives, consultants, and anyone navigating the CE marking framework.
This site does not replace official EU sources. Every page links back to the authoritative legislative text, MDCG guidance, or official Commission publication. Think of RAPath EU as a structured, searchable index that helps you find what you need — then points you to the official source to verify it.
Who this site is for
Regulatory affairs professionals and consultants — a well-structured reference for requirements you navigate daily, with every claim linked to its legislative source.
Manufacturers (EU and non-EU) — understand what MDR and IVDR require of you, from classification through to ongoing post-market obligations.
EU authorised representatives (EU REPs) — understand your joint liability and obligations under MDR Art. 11 and IVDR Art. 11.
Importers and distributors — understand your verification, record-keeping, and co-operation obligations under MDR Art. 13–14.
Anyone new to EU medical device regulation — start with Start Here for a guided introduction to the framework.
How to use this site
The site is structured around the regulatory lifecycle of a medical device under MDR and IVDR:
| Section | What it covers |
|---|---|
| Start Here | Definitions, MDR vs. IVDR, regulatory framework, key roles, device lifecycle, transitional provisions, glossary |
| Pre-Market | Classification (MDR Rules 1–22 / IVDR Rules 1–7), GSPR Annex I, technical documentation, conformity assessment (Annexes IX–XI), clinical and performance evaluation, UDI, and 11 special device types |
| Post-Market | Post-market surveillance, PSUR, PMCF/PMPF, vigilance reporting, FSCAs and recalls, EUDAMED registration, and labelling and advertising |
| Legislation | MDR and IVDR key articles, all annexes, implementing and delegated acts, Common Specifications, harmonised standards, and how to read EU legislation |
| Guidance | Full index of MDCG guidance by topic and device class, MEDDEV reference, EC Blue Guide, and forms and application links |
| What's New | Recent regulatory changes, open consultations, transitional timeline tracker, EUDAMED rollout status, notified body capacity |
| Notified Bodies | What notified bodies do, how to choose one, NANDO database, audit process and timelines, unannounced audits, Art. 54 scrutiny procedure |
| Compassionate Use | MDR Art. 59 compassionate use, named-patient access, hospital exemption, clinical investigation pathways |
| Market Surveillance | NCA roles by member state, surveillance activities, safeguard procedures (Art. 95–97), enforcement powers |
| Non-EU Access | Requirements for non-EU manufacturers, EU REP obligations, UK UKCA, Switzerland MedDO, MDR vs. FDA 510(k) |
MDR and IVDR — two separate regulations
A key feature of EU medical device law is the existence of two separate but parallel regulations:
- MDR 2017/745 — covers medical devices, accessories, and Annex XVI non-medical-purpose devices
- IVDR 2017/746 — covers in vitro diagnostic medical devices and their accessories
They are mutually exclusive — a product is governed by one or the other, never both simultaneously. Where pages apply to both regulations, they are marked accordingly. Where content is regulation-specific, the applicable regulation is noted.
→ Not sure which applies to your product? See MDR vs IVDR — which applies?
Where to start
If you are new to EU medical device regulation: → What is a medical device?
If you need to classify a device under MDR: → Classification rules 1–22
If you need to classify an IVD under IVDR: → Classification rules 1–7
If you are preparing for a notified body application: → Conformity assessment — overview
If you need to understand clinical evaluation requirements: → Clinical evaluation overview
If you need to report a serious incident: → What must be reported
If you are a non-EU manufacturer: → Non-EU & third-country access
If a recall may be required: → When an FSCA is required
Questions, corrections and discussions
RAPath EU is a community reference. If you find an error, have a regulatory question, or want to discuss a recent MDR/IVDR development, use GitHub Discussions:
Regulatory affairs professionals who flag inaccuracies are the most valuable contributors to this project.
Disclaimer
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official EUR-Lex, EC DG SANTE, and EUDAMED sources before making regulatory decisions. This site is not affiliated with the European Commission or any EU institution. Not legal or regulatory advice.