EUDAMED’s first four modules become mandatory on 28 May 2026 - what this means for medical device manufacturers

Which modules are affected

Starting on 28 May 2026, the following modules will require compulsory use under Regulation (EU) 2024/1860:

• Actor registration (registration of economic operators - manufacturers, authorised representatives, importers, etc.)
• UDI/Devices registration (device registration and unique device identifier requirements)
• Notified Bodies & Certificates (registration of notified bodies and associated device certificates)
• Market Surveillance (module supporting oversight of devices on the market)

Timing and transition

The EC published the notice declaring functionality of these modules on 27 November 2025, triggering the mandated six-month transition period under the Regulation - hence the effective date of 28 May 2026.

Until that date, use of the modules remains voluntary, but after 28 May 2026 their use becomes a legal requirement for any responsible economic operator under MDR/IVDR.

Conclusions & Recommendations

• The mandatory activation of the first four EUDAMED modules from 28 May 2026 signals a major shift toward increased transparency and regulatory compliance across the EU medical device market.
• All manufacturers, authorised representatives, importers, and notified bodies should review their readiness - including internal processes and data - to ensure timely registration.
• With our expertise, MedNet EC-REP GmbH can help navigate the transition smoothly. Contact your Regulatory Affairs Manager for further information.

Source: European Commission