European Union Medical Device Registration (EU MDR 2017/745)
1. Regulatory Authority & Framework
EU medical devices are regulated under:
- Regulation (EU) 2017/745 (MDR) – medical devices
- Regulation (EU) 2017/746 (IVDR) – IVDs (for reference)
- MDCG Guidance Documents (2017–2024 series)
- Harmonized standards (EN ISO 13485, EN ISO 14971, EN ISO 62366-1, etc.)
Authorities involved:
- Notified Bodies (NBs) – conformity assessment
- Competent Authorities of each EU Member State
- European Commission (DG-SANTE)
- EUDAMED database (progressively mandatory)
CE Marking is required for placement on the EU/EEA market.
2. Device Classification (Class I / IIa / IIb / III)
Same principle as GHTF/IMDRF but stricter under MDR.
| Class | Risk Level | Examples |
|---|---|---|
| Class I | Low | Non-sterile reusable tools |
| Class Is / Im / Ir | Low | Sterile, measuring, reusable surgical instruments |
| Class IIa | Low–Moderate | Pumps, diagnostic imaging accessories |
| Class IIb | Moderate–High | HF surgical devices, ventilators, infusion pumps |
| Class III | High | Implantables, active therapeutic devices, surgical robots |
Classification follows MDR Annex VIII Rules (1–22).
3. EU MDR Conformity Assessment Routes
The EU uses a QMS + Technical Documentation approach.
3.1 Class I (Non-sterile, non-measuring)
- Self-declaration (no NB involvement)
- Must prepare full technical documentation
- CE mark granted directly
3.2 Class Is / Im / Ir
- Notified Body required only for sterilization, measuring, reusable aspects
3.3 Class IIa / IIb / III
Require a Notified Body for conformity assessment.
Modules used:
- Annex IX – Full QMS + Technical Documentation
- Annex X – Type Examination
- Annex XI – Production Quality Assurance
Class III implantables require:
- Clinical evaluation + PMCF data
- SSCP (Summary of Safety & Clinical Performance)
- Tightest oversight by NB + Competent Authority
4. Technical Documentation Requirements (Annex II & III MDR)
4.1 Annex II – Technical Documentation
- Device description
- Design and manufacturing information
- GSPR checklist (General Safety & Performance Requirements)
- Benefit–risk analysis
- Risk management (EN ISO 14971)
- Clinical evaluation (as per MDR + MEDDEV 2.7/1 Rev.4)
- Verification & validation
- Biocompatibility
- Electrical safety & EMC (EN 60601)
- Software lifecycle (EN 62304)
- Cybersecurity
- Sterilization (EN ISO 11135/11137/17665)
- Usability (EN 62366-1)
- Labeling & IFU
- UDI assignment
4.2 Annex III – Post-Market Requirements
- PMS plan
- PMCF plan (post-market clinical follow-up)
- Periodic Safety Update Report (PSUR)
- Vigilance system
- Trend reporting
5. Clinical Evaluation Requirements
Under MDR:
- Clinical evidence expectations are much higher than MDD
- Equivalence is stricter (same manufacturer OR detailed justification)
- PMCF often required even for legacy products
Class:
| Class | Clinical Requirement |
|---|---|
| I | Literature-based acceptable |
| IIa | Clinical evaluation + PMS/PMCF |
| IIb | Strong clinical data + PMCF |
| III | Robust clinical investigation often required |
Active devices (robotics, AR navigation, HF surgical systems) require stronger clinical/performance data.
6. Quality Management System (QMS)
EU MDR requires:
- EN ISO 13485:2016 QMS
- EN ISO 14971:2019 RM
- EN ISO 62366-1 usability
- MDSAP accepted by some NBs but not a replacement for MDR conformity
NBs perform:
- Stage 1 + Stage 2 audits
- Unannounced audits
- Annual surveillance audits
7. Authorized Representative (EC-REP)
If the manufacturer is outside the EU, an EU Authorized Representative (EC-REP) is mandatory.
Responsibilities:
- Regulatory liaison
- Device registration (EUDAMED Actor module)
- Vigilance reporting support
- Keep technical documentation available for Competent Authorities
- Appears on labeling with EC-REP symbol
8. Economic Operators under MDR
Mandatory roles:
- Manufacturer
- EC-REP (if outside EU)
- Importer
- Distributor
All must comply with MDR Articles 10–16.
9. EUDAMED Requirements
EUDAMED contains 6 modules:
- Actor Registration ✔
- UDI Database ✔
- Certificates ✚
- Vigilance ✚
- Market Surveillance ✚
- Clinical Investigations & PMCF ✚
(Some modules are voluntary but becoming mandatory during 2025–2027 transition.)
10. Fees & Timelines
Notified Body Costs (Typical)
- Class I (self-declare): €0 NB fees
- Class IIa: €8,000–€20,000
- Class IIb: €20,000–€50,000
- Class III: €40,000–€100,000+
- NBs are the bottleneck; demand is very high.
Timelines
- Class I: 1–3 months
- Class IIa: 9–12 months
- Class IIb: 12–18 months
- Class III: 18–24+ months
Legacy MDD CE certificates have extended transition timelines to 2027–2028 under Regulation (EU) 2023/607.
11. Labeling & UDI Requirements
Labeling must include:
- Manufacturer & EC-REP
- UDI-DI & UDI-PI
- CE mark + NB number (for IIa/IIb/III)
- Warnings, precautions
- Sterility details
- Expiry/manufacture date
- Language: all EU languages for the markets intended
- eIFU permitted for eligible device types
12. Post-Market Surveillance & Vigilance
Manufacturers must maintain:
- PMS Plan
- PMCF Plan & Reports
- PSUR (Class IIa/IIb annually, Class III annually)
- Vigilance reporting within strict timelines:
- Serious threat: 2 days
- Serious incident: 10 days
- Other incidents: 15 days
NBs periodically re-assess clinical evidence & PMS performance.
13. Consulting Notes for Your Device Portfolio
| Device Type | EU Class | MDR Requirements |
|---|---|---|
| Soft contact lenses | Class IIb | Strong clinical data; biocompatibility + PMCF |
| Surgical robots / AR–MR navigation (SyngAR™) | Class IIb / III | High scrutiny; software V&V, cybersecurity, clinical investigations |
| High-frequency electrosurgical devices | Class IIb | IEC 60601-2-2; strong clinical/performance evidence |
| Blood glucose meters & strips | Class IIb | Must meet EN ISO 15197; clinical accuracy + PMCF |
| Single-use serum preparation devices | Class IIa / IIb | Sterilization + validation + PMS/PMCF |
14. Advantages of the EU Market
- CE mark recognized globally
- Harmonized 27-country access
- High credibility with regulators (GCC, ASEAN, LATAM)
- Strong alignment with GHTF/IMDRF
- Encourages innovation (AI/ML guidance, software rules evolving)