December 18, 2023
In a joint open letter sent to the European Commission, AESPG, COCIR, EUROM, EUROMCONTACT, MedTech Europe and EHIMA address the early mandatory availability of the European medical devices database (EUDAMED). In the letter, we highlight crucial preconditions for its success, such as:
- Stressing the need for fully developed, tested, and audited modules before mandating any aspect of EUDAMED.
- Ensuring efficient use of resources, realistic timelines, and eliminating redundancy in National Databases.
- Emphasising smooth integration of mandatory modules for user-friendliness and avoiding rework.
- Setting realistic timelines with a lead time of at least 24 months to align procedures and resources.
- Eliminating redundancy by not requiring registration in national databases once registered in EUDAMED.
Our industry associations fully support the integration of EUDAMED into the MDR and IVDR, emphasising the database’s integrity and practical implementation.
Read the full letter here: https://www.ehima.com/wp-content/uploads/2023/12/Joint-open-letter_In-anticipation-of-EUDAMED-availability-for-mandatory-use-December-2023.pdf