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European Union Medical Device Registration

Notified Bodies under EU MDR 2017/745 (EU MDR) approval timelines and requirements

6-9 months
Typical Timeline
4
Device Classes
No
MDSAP Accepted
Required
EU Authorized Representative

European Union Medical Device Registration Overview

European Union medical device registration through EU MDR typically takes 6-9 months for Class I devices. The official EU MDR target is 3-6 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.European Union uses a 4-class (I, IIa, IIb, III) risk-based classification system. Foreign manufacturers must appoint a EU Authorized Representative to register devices in European Union. Registration is valid for 5 years (CE certificate).

Registration Timeline by Device Class

European Union uses a 4-class (I, IIa, IIb, III) risk-based classification system.

Class I

Self-certification

Low Risk
Official
3-6 months
Realistic
6-9 months

• No Notified Body required (unless sterile/measuring)

• EUDAMED mandatory Q4 2027

GMP/QMS Required

Class IIa

Notified Body certification

Medium Risk
Official
8-12 months
Realistic
1.1-1.5 years

• Notified Body capacity constraints

• 45% report 6-12 month lead time

GMP/QMS Required

Class IIb

Notified Body certification

High Risk
Official
1-1.5 years
Realistic
1.3-2 years

• Clinical evaluation required

• Implantables often need clinical trials

GMP/QMS Required

Class III

Full Notified Body review

Highest Risk
Official
1.5-2 years
Realistic
2-3 years

• Clinical investigations typically required

• Article 54 expert panel review

Clinical Trial RequiredGMP/QMS Required
Expedited Pathways

Article 59 Derogation

National-level exemption for public health emergencies

Immediate market access
Eligibility: Public health emergencies only, Not for commercial reasons

Legacy Device Transition

Extended deadlines for MDD-certified devices

Until Dec 2027 (Class III) or Dec 2028 (others)
Eligibility: Valid MDD certificate on Mar 20, 2023, No significant changes
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your European Union registration.

FDA 510(k)
Clinical data can be leveraged
2-4 months prep time
MDD CE Mark
Extended market access during transition
Until 2027-2028
ISO 13485
QMS foundation for MDR
2-4 months
Key Requirements
  • EU Authorized Representative (for non-EU manufacturers)
  • Technical Documentation (Annex II & III)
  • Clinical Evaluation Report
  • Post-Market Surveillance system
  • EUDAMED registration
  • UDI implementation
Registration Validity:

5 years (CE certificate)

Registration Process Flowchart

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 weeks

Classify device under EU MDR Annex VIII rules. Determine conformity assessment route.

Step 2: Appoint EC REP

2-4 weeks

Foreign manufacturers must appoint an EU Authorized Representative (EC REP) for regulatory correspondence.

Step 3: Technical Documentation

3-9 months

Prepare EU MDR-compliant technical file including clinical evaluation, risk management, and biocompatibility.

Step 4: Notified Body Engagement

6-18 months

Contract with Notified Body (BSI, TUV, etc). NB capacity is limited; queue times 6-18 months.

Step 5: Conformity Assessment

6-12 months

Notified Body audits QMS (ISO 13485) and reviews technical documentation. May conduct facility audit.

Step 6: CE Marking

1-2 weeks

Upon successful assessment, affix CE mark. Register in EUDAMED. Certificate valid 5 years.

Summary: The European Union medical device registration process through Notified Bodies under EU MDR 2017/745 (EU MDR) consists of 6 main steps: Device Classification → Appoint EC REP → Technical Documentation → Notified Body Engagement → Conformity Assessment → CE Marking.
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.