Medical devices: Mandatory EUDAMED modules to apply from May 2026

EUDAMED (European Database on Medical Devices) is EU's central digital platform for collecting, managing and sharing information about medical devices.

On 27 November 2025, the European Commission published an official Notice in the Official Journal of the European Union (OJEU) confirming that four EUDAMED modules are now technically functional. This publication triggered a six-month transition period, meaning that the use of these four modules will become mandatory for all relevant actors from 27 May 2026 under the EU's device regulations, including the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR, Regulation (EU) 2017/746).

The European Commission's implementation reflects a broader strategy to strengthen transparency, traceability and post-market surveillance across the EU medical device ecosystem.

The modules that will become mandatory are:

• Actor Registration
  This module governs the registration of manufacturers, authorised representatives and importers. Economic operators must ensure that their organisational information is complete and up to date and that Single Registration Numbers (SRNs) are obtained well before the 2026 deadline.

• UDI / Device Registration
  This module centralises device identification and traceability requirements. Manufacturers will be required to upload device data, including Unique Device Identifiers (UDIs), directly into EUDAMED. Preparation of device master data and alignment of internal systems with MDR and IVDR UDI requirements will be essential.

• Notified Bodies & Certificates
  Notified bodies will be required to register certificates and upload relevant Summary of Safety and Clinical Performance (SSCP) documents. They have until 27 May 2027 to complete the upload of existing certificates.

• Market Surveillance
  National authorities will begin using the market surveillance module as the central platform for their activities. Economic operators can expect greater transparency and more harmonised enforcement across the EU.

The move to make these four modules mandatory is part of the EU's continued roll-out of the MDR and IVDR framework. While EUDAMED's full implementation has been delayed in past years, the 2026 milestone is a clear signal that manufacturers should expect increased digitalisation and more harmonised enforcement across Member States.

What to do?

Manufacturers and other economic operators should already now begin preparing their data, internal processes and systems to be ready to use the new modules. 

Want to Know More?

Read the European Commission's Q&A document on the practical aspects of the implementation

If you have any questions, please contact Plesner's Life Science team.