The European Commission (EC) has confirmed that it is delaying the launch of the European Database on Medical Devices (Eudamed) until May 2022.
The database will be used to monitor both the safety and performance of medical devices, with the intention of improving transparency, as well as the co-ordination of information regarding medical devices in the European Union.
Sophie Dupin De Saint-Cyr, press officer for internal market, industry, entrepreneurship and SMEs & regional policy at the European Commission, said that: "The Commission concluded that it will only be possible to make Eudamed operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit."
The new launch date coincides with the proposed date for the implementation of the In Vitro Diagnostic regulation, due to come into force on May 26, 2022.
Companies have reportedly been struggling with the amount of time and resources, particularly relating to IT, that the Eudamed project is requiring of them.
The delay gives companies more time to prepare their systems and to populate the database, while it also provides the EC with more time to complete some of the as-yet-unfinished Eudamed modules.
The delay, however, does not extend the date at which the Medical Device Regulation will take effect, which remains May 26, 2020.