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 | 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.