EC Proposes Making Parts of EUDAMED Mandatory

By Annette Van Raamsdonk

The European Commission (EC) proposal to delay the compliance of IVDs also proposes a gradual roll-out of the European database on medical devices, EUDAMED. The EC proposes that certain modules of EUDAMED would become mandatory before completing all six modules.

Originally, EUDAMED would be compulsory only once all six modules were completed and validated (Article 34 Regulations (EU) 2017/745 (MDR) and Article 30 (EU) 2017/746 (IVDR)).

The six modules include:

1. UDI/Devices
2. Actors
3. Notified bodies/Certificates
4. Post-Market Surveillance and Vigilance
5. Market Surveillance
6. Clinical Investigations/Performance Studies                                                                           

Three of the modules have been released for voluntary use. However, there appear to be issues with the last module, Clinical Investigations/Performance Studies.

What can we expect concerning EUDAMED?

The MDR and IVDR are proposed to be amended, requiring EUDAMED modules to become mandatory earlier (from the end of 2025).

What modules could we expect again?

The UDI/Devices, Actors, Notified Bodies/Certificates modules have already been made available for voluntary use; however, use is limited. The Actors module was released in December 2020  and manufacturers, European Authorized Representatives and Importers were able to register in EUDAMED, after requesting a Single Registration Number (SRN). In October 2021, the device registration (UDI/Devices) and the Notified Bodies/Certificates modules were launched. The module on UDI/Devices should allow transparency on which devices are available in the EU and the manufacturer of the devices. The UDI/Devices module should eventually replace member state databases, but currently, manufacturers still appear to be registering their devices in national databases instead of EUDAMED.

The module on Market Surveillance (intended only for member states to share surveillance activities) and the module on Post-Market Surveillance and Vigilance are expected to be completed in Q2 of 2024. The EC does not expect the module on Clinical Investigations and Performance Studies to go live before Q3 of 2026.

“Obligations in case of interruption of supply of certain devices”

If the proposal is accepted by the European Parliament and Council and adopted, the modules that are ready will become mandatory gradually. Modules would become mandatory six months after the date of publication of the notice in the Official Journal of the European Union  (Article 34(3) MDR and Article 123(3) MDR).

The proposal impacts all who are required to use EUDAMED. Manufacturers will need to start preparing to enter device data in EUDAMED. National registration requirements will end when the registration requirements in EUDAMED start to apply. This is all with the aim of continuity of health care and enhancing transparency.

The proposal adds a new article to the MDR and IVDR, Article 10a, requiring manufacturers who foresee an interruption of supply of their IVD or medical device, to inform member states affected, as well as the economic operators and healthcare /professionals to whom they directly supply the device. The EC aims to avoid disruption of healthcare with the implementation of this proposal.