The European Commission (EC) has announced a two-year delay to the implementation of it’s new EUDAMED database under the incoming Medical Device Regulation (MDR).
However, the date of application of MDR remains as May 2020. EUDAMED’s launch will be synchronised for both the MDR and the In-Vitro Device Regulation (IVDR), for which the date of application is currently May 2022, with a two-year transition to 2024.
The current database, EUDAMED2, is restricted to national competent authorities and is not publicly accessible. The new EUDAMED is a larger database, which will be used to monitor the safety and performance of devices, with improved transparency and coordination of information regarding medical devices available on the European Union (EU) market. It will consist of a variety of modules such as actors, Unique Device Identification and devices, notified bodies and certificates, vigilance, clinical investigations, performance studies and market surveillance. The primary factor behind the Commission’s delay is that all of the modules have not achieved full functionality.
This can be construed as “a real positive for the industry” and an opportunity for companies to consolidate preparations with regards to their MDR EUDAMED projects. The EUDAMED project can be expensive and challenging in terms of time and IT resources. The delay does not alter the requirements for MDR EUDAMED implementation, but it should give manufacturers time to enter their device data and perfect their preparations.
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