A Commission Decision entering into force on 27 November confirmed that certain electronic systems meet their required functional specifications. This decision has triggered a six-month transition period, as outlined in the Regulation governing EUDAMED’s gradual roll-out. This would mean that the following modules will become mandatory 6 months after this publication. This would make the mandatory implementation date of 28th May 2026.
- Actor registration
- UDI/Devices registration
- Notified Bodies & Certificates
- Market Surveillance
To offer some background to this news item, EUDAMED is the European database for medical devices and in vitro diagnostic medical devices. Its purpose is to collect and share essential information, enhancing safety, transparency, and coordination across the European Union. The system makes key data accessible to citizens, manufacturers, and national authorities.
The full implementation of EUDAMED will bring several important benefits to the sector:
- A centralized platform to register devices, systems, procedure packs, and certificates across the EU
- A Single Registration Number (SRN) issued by the competent national authority
- Reduced Administrative Workload
- Greater transparency
- Improved traceability of medical devices
- Enhanced market surveillance
More information in Commission Decision EU 2025/2371 can be found using the following link
How Advena Can Help
Navigating EUDAMED requirements can be complex. If you need support with device registration or assistance obtaining your Actor ID (SRN), the Advena Team is ready to guide you through the process and ensure your compliance with the upcoming obligations.
