Recent regulatory changes
This section is updated regularly to reflect changes in EU medical device regulation. Sources monitored include: Official Journal of the EU, MDCG meeting outputs, Commission DG SANTE announcements, and NCA publications.
This site provides general information only. Always verify regulatory changes against official sources before acting on them.
How to stay current
EU medical device regulation moves quickly — new MDCG guidance, implementing acts, transitional deadline changes, and NCA announcements occur regularly. The most reliable sources for current information are:
| Source | What it covers | URL |
|---|---|---|
| Official Journal of the EU | All binding legislation — regulations, implementing acts, delegated acts | eur-lex.europa.eu → OJ L series |
| EC DG SANTE — medical devices | MDCG guidance, Commission announcements, consultations | health.ec.europa.eu/medical-devices |
| EUDAMED news | EUDAMED implementation status and new features | ec.europa.eu/tools/eudamed |
| MDCG meeting documents | Published minutes and adopted guidance after each MDCG meeting | EC DG SANTE website |
| EMA news | Drug-device combinations, companion diagnostics | ema.europa.eu |
| NCAs (national) | Country-specific guidance and enforcement updates | Varies by member state |
| TEAM-NB | Notified body consensus positions | team-nb.org |
Key recent changes — summary timeline
2024
Regulation (EU) 2024/1860 — Further IVDR transitional extensions published. Extended all IVDD legacy device certificate validity dates by approximately two years (Class D to Dec 2027, Class C to Dec 2028, Class B to Dec 2029, Class A self-declared to Dec 2030).
EU AI Act (Regulation (EU) 2024/1689) — Entered into force. Many medical AI devices that are already regulated as medical devices under MDR will also be classified as high-risk AI systems under the AI Act. Parallel compliance obligations will apply. The Commission is working on guidance on how the two regulatory frameworks interact.
New MDCG guidance documents — Various guidance updates on vigilance reporting (MDCG 2023-3), PSUR (MDCG 2022-21), and technical documentation continue to be published.
2023
Regulation (EU) 2023/607 — Extended MDR transitional provisions. Manufacturers who had valid MDD/AIMDD certificates and met specific conditions gained additional time to complete MDR conformity assessment.
EUDAMED — Additional modules moved toward mandatory use. Manufacturers continue to be onboarded to UDI/device registration and vigilance modules.
2022
IVDR applied from 26 May 2022 — After a one-year delay, IVDR became fully applicable. Class D IVDs faced the earliest deadline; most other IVD classes are transitioning under extended timelines.
Regulation (EU) 2022/112 — First IVDR transitional extension, providing additional time for Class B, C, and D IVDs to transition from IVDD to IVDR certification.
Upcoming changes to watch
| Change | Expected timing | Impact |
|---|---|---|
| IVDR Class D certificate deadlines | Dec 2027 | All Class D IVDs must have IVDR certification |
| MDR Class III certificate deadlines | Dec 2027 | All Class III MDR devices must have MDR certification |
| Annex XVI Common Specifications (groups 2–6) | TBC — Commission work programme | Will activate regulatory requirements for cosmetic/aesthetic device categories |
| EUDAMED mandatory use — remaining modules | Phased | Clinical investigation and vigilance modules moving to mandatory |
| AI Act implementation for medical AI | 2026–2027 | Medical AI manufacturers face dual MDR/IVDR and AI Act compliance |
→ See Reforms tracker for a detailed current tracking table.