Es ist soweit! Die Kommission der Europäischen Union hat die verpflichtende Einführung von EUDAMED bereits 2017 in der MDR (Verordnung (EU) 2017/745) beschlossen – jetzt naht der Stichtag.
From 28 May, all medical devices placed on the market in the EU must be registered via the EUDAMED platform and will be assigned a Unique Device Identifier via this electronic registration system.
For all products already on the market that have not yet been registered with EUDAMED, the deadline is 28 November this year. By that date, all so-called legacy devices must also be registered with EUDAMED – regardless of whether they have already been registered for years in national registers such as the German DMIDS.
The introduction of the EUDAMED registration requirement means that registration with DMIDS is no longer necessary or possible.
Two Deadlines – Two Requirements
In a nutshell:
From 28 May 2026 onwards , all products that have not yet been registered must be notified via EUDAMED.
“Not yet registered” means: all products intended for sale on the EU market that have not yet been registered via the relevant national registers, such as DMIDS, or the European register EUDAMED.
From 28 November 2026 onwards , all legacy devices must be registered via EUDAMED.
“Legacy devices” are medical devices that have already been authorised and are being marketed, but which have not yet been registered via EUDAMED.
Please note! “Legacy device” is a general term referring to products that were certified under regulations that are being phased out but have not yet expired. In this context, the term refers exclusively to medical devices without EUDAMED registration.
Take Action.
Manufacturers are required to comply with the Commission’s deadlines. Any legacy devices that have not been registered via EUDAMED by 28 November 2026 will lose their authorisation and must be withdrawn from the market immediately.
All products that are not yet ready for registration via EUDAMED should be prepared for this as soon as possible.
Need Help?
Although the registration process via EUDAMED is no more complicated than that via DMIDS or similar registries, specific requirements and strict adherence to the prescribed format are required. You will need the 13-digit UDI-DI code, and you must already be registered with EUDAMED as an economic operator. It is not advisable to wait until the week of the deadline to complete these steps.
BEO BERLIN has produced two tutorials that explain the registration process for economic operators and for products step by step.
Take a look at our tutorial on manufacturer registration (Step 1):
And our tutorial on product registration (Step 2):
And if you would like further advice or support, our experts are here to help.
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