On Thursday, May 30, the Council of the European Union approved, without debate, new rules updating legislation on medical devices in order to prevent deficiencies and facilitate the transition to greater transparency and access to information.
The Regulation amends the legislation on medical devices, including in vitro diagnostic medical devices, by further extending the transition period for certain in vitro diagnostic medical devices.
Furthermore, allowing the gradual development of EUDAMED, the new electronic database.
Whereas it requires manufacturers to report potential shortages of critical medical devices and in vitro diagnostic medical devices.
Note that in 2017 new rules were introduced to modernize the EU framework for in vitro diagnostic medical devices.
Under certain conditions, changes extend the transition period to the new system in order to avoid loopholes.
The new regulation allows for the gradual development of EUDAMED, requiring manufacturers to provide information about their products in existing EUDAMED modules, without having to wait for the remaining modules to be completed.