EU Trans Reg ID: 221589017973-83
Medical Devices, In Vitro Diagnostics and Eudamed
Medical Devices, In Vitro Diagnostics and Eudamed
The EU has released new guidance governing medical devices – the first time in 20 years. The most important changes include:
- Increased scope of medical device definition
- more stringent linguistic requirements for medical devices sold in the EU market
- New classification rules (including Rule 11 that specifically addresses software)
- Increased scope of general safety and performance requirements, technical documentation, and clinical data and evaluation requirements
- Introduction of traceability and identification system and database
- Increased post-market product surveillance
The medical devices regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR) replace the three Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices. The MDR came into application on 26 May 2021 but provides for a transitional period for certain devices. The IVDR came into application on 26 May 2022 but also provides for a transitional period for certain devices. These regulations include provisions concerning the responsibilities of the EMA, National Competent Authorities (NCA) for medicinal products and medical devices and notified bodies as regards combinations of medicinal products with medical devices.
All legacy devices must be MDR compliant by the end of December 2028.
| EXPERT PANELS ON MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (EXPAMED)
Calls for expression of interest for:
The calls are managed by the European Medicines Agency as part of their expanded mandate to include medical devices in addition to medicinal products.
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