Skip to content

Spring 2024 target for EUDAMED

Published by Alec Denniff, Medical Device Paralegal on

The European Commission has released an updated EUDAMED timeline, targeting the second quarter of 2024 for full functionality of the EUDAMED database. 

EUDAMED is the centralised European database for various medical device regulatory functions. EUDAMED was established by Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (the IVDR). The database was then developed by the European Commission. It will ensure that every medical device authorised for use across the EU Member States is registered in one single centralised database. In addition, it will provide national medical device regulators and device manufacturers with the ability to review the authorised use of devices, safety issues, recalls and upcoming regulations. The Commission has stated their hope that the database will enhance overall transparency, including enabling better access to information for the public and healthcare professionals, as well as facilitating coordination between the EU Member States. 

The database is structured around six modules and a publicly available website. The modules include:

  • Actor registration 
  • UDI/Devices registration
  • Notified Bodies and Certificates
  • Clinical investigations and performance studies
  • Vigilance and post-market surveillance
  • Market surveillance 

Originally scheduled to launch in 2020, EUDAMED is now subject to a staggered module rollout (although some modules are already currently available). It will only become mandatory to register on EUDAMED once it is completely rolled out. However, actor registration – the module which enables economic operators (manufacturers, importers, distributors etc.) to submit actor registration requests – has been available for voluntary[1] use since December 2020. Equally, the module on UDI/device registration, which is expected to facilitate the device identification system based on a unique device identifier, has been available for voluntary use since October 2021.[2]

It is expected that the remaining modules – clinical investigation and performance studies, vigilance and market surveillance – will require another two years of development. To meet the targets set, the EUDAMED development team will need to complete the minimum viable product (MVP) of all six modules by the end of the fourth quarter of 2023. Completion of the MVP of all six modules will enable an independent audit to be conducted in early 2024 and results to be presented to the Medical Device Coordination Group (MDCG) for review. 

Once fully functional, industry will have defined transitional periods to comply with the requirements of EUDAMED. These transitional periods will differ depending on the module. For instance, for the modules on actor registration, vigilance, clinical investigation and performance studies and market surveillance, a six month transition period is envisaged. This period will commence six months from the date on which EUDAMED becomes fully functional, which is expected to be in the fourth quarter of 2024. For the remaining modules - UDI/device registration and Notified Bodies and Certifications, a two year transitional period is mandated, ending in the second quarter of 2026. This would be two years after the expected date of full functionality of the database and six years after the originally targeted launch date. 

We are monitoring developments regarding the functionality of the EUDAMED database and will provide additional reporting when updates are announced. Subscribe to our newsletter for more insight and content on medical device regulation!

 

[1] The Commission cannot require mandatory use of the actor registration module until EUDAMED is fully functional according to the MDR and IVDR

[2] As above, the Commission cannot require mandatory use of UDI/device registration until EUDAMED is fully functional.