EU MDR

The EU Medical Device Regulation (MDR 2017/745) is the comprehensive regulatory framework governing medical devices in the European Union. It replaced the Medical Devices Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD 90/385/EEC).

Key dates:
- Published: May 5, 2017
- Entered into force: May 25, 2017
- Date of application: May 26, 2021
- MDD certificates valid until: December 31, 2027/2028

Major changes from MDD:
1. Stricter clinical evidence requirements
2. Enhanced post-market surveillance obligations
3. Unique Device Identification (UDI) mandatory
4. EUDAMED central database
5. Increased Notified Body oversight
6. Person Responsible for Regulatory Compliance (PRRC) required
7. Expanded scope to include certain aesthetic devices
8. Reclassification of some device types

Device classification under EU MDR:
- Class I - Lowest risk (includes Im, Is, Ir sub-classes)
- Class IIa - Low-medium risk
- Class IIb - Medium-high risk
- Class III - Highest risk

Conformity assessment routes:
- Self-declaration (Class I non-sterile, non-measuring)
- Notified Body certification (higher classes)

Key annexes:
- Annex I - General Safety and Performance Requirements
- Annex II - Technical Documentation
- Annex XIV - Clinical Evaluation
- Annex XV - Clinical Investigations

EU MDR significantly increased the regulatory burden but aims to ensure higher safety standards and better patient outcomes across Europe.