The 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.
The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by:
- further extending the transition period for certain IVDs
- enabling a gradual roll-out of EUDAMED, the new electronic database
- requiring manufacturers to flag up potential shortages of critical medical devices and IVDs…
