On Thursday 30 May, the Council of the European Union adopted, without debate, new rules updating the legislation on medical devices to help prevent shortages 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; - enabling a gradual roll-out of EUDAMED, the new electronic database; - requiring manufacturers to report potential shortages of critical medical devices and in-vitro diagnostic medical devices.
In 2017, new rules were introduced to modernise the EU framework for in-vitro diagnostic medical devices. Under certain conditions, the amendments extend the transition period to the new system in order to avoid shortages. The new regulation (see EUROPE 13419/14) allows for a gradual roll-out of EUDAMED, by requiring manufacturers to provide information on their products in existing EUDAMED modules without having to wait for the remaining modules to be completed. (Original version in French by Lionel Changeur)