EU MDR (Medical Device Regulation)
European Union Medical Device Regulation 2017/745, the current regulatory framework governing medical devices in the EU. EU MDR replaced the Medical Devices Directive (MDD) and imposes stricter requirements for clinical evidence, post-market surveillance, and traceability.
The EU Medical Device Regulation (EU MDR 2017/745) is the regulatory framework that governs the marketing and sale of medical devices in the European Union. It replaced the older Medical Devices Directive (MDD 93/42/EEC) with significantly stricter requirements.
Key changes from MDD to MDR
- Clinical evidence: Stronger requirements for clinical evaluation reports and post-market clinical follow-up
- UDI: Unique Device Identification required for all devices
- EUDAMED: European database for medical devices — public transparency on device safety
- Notified Body audits: More rigorous oversight of Notified Bodies and unannounced audits
- Reclassification: Some devices reclassified to higher risk categories
EU MDR in tenders
EU tenders now require MDR-compliant Declarations of Conformity, current Notified Body certificates referencing MDR (not MDD), and evidence of EUDAMED registration. Products still relying on MDD certificates may face compliance gaps.