European Union medical device registration timeline
Source-linked clocksNotified Bodies under EU MDR 2017/745 (EU MDR) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration (no notified body)) MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty | 0 days | 6-9 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
European Union Medical Device Registration Process
Step-by-step EU MDR registration process. Total estimated timeline: 6-9 months.
Step 1: Device Classification
2-4 weeksClassify device under EU MDR Annex VIII rules. Determine conformity assessment route.
Step 2: Appoint EC REP
2-4 weeksForeign manufacturers must appoint an EU Authorized Representative (EC REP) for regulatory correspondence.
Step 3: Technical Documentation
3-9 monthsPrepare EU MDR-compliant technical file including clinical evaluation, risk management, and biocompatibility.
Step 4: Notified Body Engagement
6-18 monthsContract with Notified Body (BSI, TUV, etc). NB capacity is limited; queue times 6-18 months.
Step 5: Conformity Assessment
6-12 monthsNotified Body audits QMS (ISO 13485) and reviews technical documentation. May conduct facility audit.
Step 6: CE Marking
1-2 weeksUpon successful assessment, affix CE mark. Register in EUDAMED. Certificate valid 5 years.
National-level exemption for public health emergencies
Eligibility: Public health emergencies only, Not for commercial reasons
Extended deadlines for MDD-certified devices
Eligibility: Valid MDD certificate on Mar 20, 2023, No significant changes
- EU Authorized Representative (for non-EU manufacturers)
- Technical Documentation (Annex II & III)
- Clinical Evaluation Report
- Post-Market Surveillance system
- EUDAMED registration
- UDI implementation
- Clinical investigation clocks (MDR Art. 70): member state notifies validation within 10 days; sponsor completes application within max 10 days (+20 extension); authorisation decision within 45 days of validation (+20 with expert extension); clock suspended during information requests (IVDR Art. 66/74 analogous)
- Notified-body certification became time-bound only with Implementing Regulation (EU) 2026/977: before it applies on 25 Feb 2027 the review duration is purely contractual, and Art. 8(1) leaves procedures contracted before that date uncapped
- Re-certification under Reg. (EU) 2026/977 Arts. 5-7: the notified body assesses the renewal documentation within 90 days and issues the certificate within a further 20 days, and Art. 8(3) excludes certificates expiring before 25 Nov 2027
- Substantial changes to an approved quality system or device under Reg. (EU) 2026/977 Art. 2(3): 30 days to review the planned change, 90 days for any additional assessment, 20 days to issue the certificate supplement
- Notified bodies must quote estimated cost and timeline up front and flag any cost increase above 10% (Reg. (EU) 2026/977 Art. 1), and from 1 Jan 2028 publish annual median duration and cost figures (Art. 4(4))
- NB surveillance audits at least every 12 months and unannounced audits at least every 5 years
Reviewed 2026-08-29. End-to-end totals remain planning estimates.