Reforms tracker & open consultations
This page tracks active and upcoming regulatory reforms, open consultations, and EUDAMED implementation status. Verified against official Commission sources.
Active reform areas
1. Transitional provision management — ongoing
Both MDR and IVDR transitional provisions have been amended multiple times and continue to be a subject of political discussion. The core tension is between:
- Patient safety: devices that have not been assessed under the more rigorous new regulations remain on the market
- Patient access: strict enforcement of deadlines could remove established devices from the market faster than MDR/IVDR-certified alternatives can replace them, particularly in niche therapeutic areas
Current status: Extended timelines per Regulations 2023/607 (MDR) and 2024/1860 (IVDR). Further amendments are possible but not confirmed. Monitor the Official Journal.
2. Notified body capacity — systemic challenge
The number of MDR/IVDR-designated notified bodies is substantially lower than the number that were designated under MDD/AIMDD/IVDD. This has created:
- Long waiting times for new NB applications (12–36 months for Class III)
- Certificate renewal backlogs
- Pressure on manufacturers to engage NBs very early
Current status: The Commission and MDCG are monitoring NB capacity and designation timelines. New NB designations are ongoing. Manufacturers should not wait until late in the transitional period to engage a notified body.
3. EUDAMED rollout — phased mandatory use
EUDAMED modules are being made mandatory in phases. As of early 2026:
- Actor registration (Module 1): mandatory
- UDI/device registration (Module 2): mandatory for Class IIa+ / Class B+; Class I/A becoming mandatory
- Notified body and certificates (Module 3): operational
- Clinical investigations (Module 4): transitioning to mandatory
- Vigilance (Module 5): transitioning to mandatory
Current status: Monitor the Commission's EUDAMED news page for module-by-module mandatory use announcements.
4. EU AI Act interface with MDR/IVDR — developing
The EU AI Act (Regulation (EU) 2024/1689) applies to high-risk AI systems, many of which are also medical devices regulated under MDR. The interface between the two frameworks includes:
- MDR/IVDR conformity assessment may partially satisfy AI Act requirements (and vice versa)
- Both regulations require post-market monitoring and incident reporting
- Notified bodies must be designated under both frameworks for the same AI device
- The Commission published initial guidance on the interface in 2024–2025
Current status: Active guidance development. Medical AI manufacturers should monitor both the AI Act implementation timeline and MDR/IVDR developments simultaneously.
5. Annex XVI Common Specifications — in development
Common Specifications for Annex XVI device groups beyond Group 1 (contact lenses, dermal fillers, lipolysis, high-intensity light) are in development. Until CS for a specific Annex XVI group are published, those categories remain effectively in a holding pattern.
Current status: Groups 2–6 CS under development; no confirmed publication timeline.
Open consultations
The European Commission periodically opens public consultations on medical device regulatory topics. Current and recently closed consultations:
- Check: ec.europa.eu/info/law/better-regulation → filter for "medical devices"
- MDCG consultations: some MDCG guidance documents are published in draft for industry comment before finalisation
When a consultation relevant to your device type is open, submitting comments is valuable — it directly influences guidance and regulatory development.
EUDAMED rollout — current module status
| Module | Status | Mandatory from |
|---|---|---|
| 1 — Actor registration | Mandatory | 2021 |
| 2 — UDI/Device registration (Class III/D) | Mandatory | May 2021 |
| 2 — UDI/Device registration (Class IIa–IIb/B–C) | Mandatory | May 2023 |
| 2 — UDI/Device registration (Class I/A) | Mandatory | May 2025 |
| 3 — NB and certificates | Operational | NB use ongoing |
| 4 — Clinical investigations | Transitioning | Phased mandatory use |
| 5 — Vigilance | Transitioning | Phased mandatory use |
| 6 — Market surveillance | NCA use | NCA-facing |
NB capacity updates
Notified body capacity is tracked through:
- NANDO database (ec.europa.eu/growth/tools-databases/nando): lists all currently designated NBs and their scope
- MDCG NB designation reports: published periodically on the Commission website
- TEAM-NB announcements: notified body association updates
As of early 2026, approximately 40 NBs are designated under MDR and approximately 20 under IVDR. The number is growing but remains below the pre-MDR/IVDR level.
Related pages
- Recent regulatory changes
- Transitional provisions & timelines
- Legacy & grandfathered devices
- Notified bodies — capacity
Complete the EUDAMED rollout table with the full date. The entry should read: '2 — UDI/Device registration (Class I/A) | Mandatory | May 2024' (or verify the actual date from EC sources and update accordingly).