Change Comes Into Effect
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 entry into force of the EUDAMED registration requirement means that registration with DMIDS is no longer necessary or possible.
A guideline from the German BfArM regarding this transition can be found here.
Two Deadlines – Two Obligations
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.
Looking for Support?
Do you market products that are not yet registered with EUDAMED?
Are you planning to develop a product, or are you already in the process of doing so, but still unsure about what is required for EUDAMED registration?
Would you like a bit more clarity on the steps involved in obtaining a BUDI, UDI-DI or UDI-PI?
Are you wondering what the acronyms in the last sentence actually mean?
Then you’re in good hands at BEO BERLIN!
We have already posted two tutorials on our YouTube channel on how to register products and actors with EUDAMED. Do have a look!
And if you have any further questions: Contact our team!
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