Deadline 28 November 2026
No. The registration duty applies to manufacturers, authorised representatives and importers. Pure distributors do not have to register. They are still affected, only indirectly: through the products in their range and the proof that comes with them.
EUDAMED is the European database for medical devices. Devices that continue to be placed on the market after 28 May 2026, meaning they keep being sold, must be registered there by 28 November 2026. Devices that are not registered may no longer be placed on the market after that date. Registration is the job of manufacturers, authorised representatives and importers, not the distributor.
Not the registration, but the work around it. Under Article 14 of the Medical Device Regulation (MDR), the distributor checks what it passes on: CE marking, declaration of conformity (the manufacturer's proof that the device meets the requirements), manufacturer information. Plus traceability: where a device came from and where it went. Until 28 November, in practice that means:
Asking suppliers whether and when their devices are registered. One email, one reply, one follow-up per supplier.
Requesting proof and filing it, with a date, so it can be found next time.
Going through the range so that no gap opens on 29 November because a device is not registered.
We do not handle registration and we do not advise on the MDR. We build the systems that let the tasks around it run on their own: the question goes out to the supplier, the reply lands in the supplier file, missing proof gets chased, a person only sees what is still open. If at least three people in your company sit on tasks like these, a conversation is worth it.
As of 6 September 2026. Not legal advice. What applies to your range, clarify with the manufacturer or importer.