As expected, the EU Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information.
These new regulations aim to prevent shortages by encompassing the following:
- Extending the transition period for certain IVD’s, namely:
- December 2027 for Class D devices
- December 2028 Class C devices
- December 2029 Class B devices
- December 2029 Class A sterile devices
- Gradual Roll-Out of EUDAMED, making some modules compulsory as from Q4 of 2025/Q1 of 2026.
- Requirements for manufacturers to flag potential shortages of critical medical devices and IVD’s.
The regulation that has adopted will enter into force following publication in the EU’s Official Journal.
More information can be found using the following link
