Do you sell medical devices? If you haven’t started yet, now is the time to prepare.

Registration of your company and medical devices in EUDAMED, the EU’s central database for medical devices, will become mandatory from the first half of 2026.

It’s not just a legal requirement – it’s an opportunity to show that your products are CE-marked, safe, and ready for the European market.

What is EUDAMED?
EUDAMED is the EU database and IT system for medical devices, including IVDs and aesthetic devices under the Medical Device Regulation (https://lnkd.in/e_VEr9aC).

It increases transparency for healthcare professionals and the public and improves coordination across EU Member States.

By late 2026, certificates issued by Notified Bodies will also be available in EUDAMED.

Why register?
Legal requirement – selling without registration will be illegal.
Market advantage – demonstrate that your products are safe, CE-marked, and competitive.

Who needs to register?
• Manufacturers of CE-marked devices
• Importers of CE-marked devices
• Authorised Representatives
• Responsible persons for procedure packs/systems

If you need support or guidance, don’t hesitate to contact us.