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Medical Devices – European Regulation 2017/745 – Route to EUDAMED: The new Actor registration is now active

By Alessandro Bider

21 December, 2020


Medical Devices – European Regulation 2017/745 – Route to EUDAMED: The new Actor registration is now active

Alessandro Bider



How Should Companies Be Responding to EUDAMED?

Responding to changes in regulation can be tough, especially when the regulation’s implementation is slow and piecemeal.

Such is the case with the European Commission’s planned introduction of EUDAMED – an IT system which will implement regulation on medical devices and in-vitro diagnosis devices across the European Union.

The problem is this: the EU doesn’t expect EUDAMED to be fully operational until 26th may 2022, and intends to introduce it progressively over time. This means companies are left unsure when and how to act in order to stay apace with these new EU requirements.

What is EUDAMED?

EUDAMED stands for European Databank on Medical Devices, and its stated purpose is to enhance transparency and market surveillance in the EU with regards to medical devices.

Functionally, it is a multi-purpose system, structured around six interconnected modules and a public website; the idea is for it to act as a central hive, enabling the secure and efficient transfer of information between national authorities and European Commission.

How is it being introduced?

This is where things get more complicated: the Actor Registration Module, for example, is currently active and available.

This allows the registration of Manufacturers, Authorised Representatives and Importers into the system, enabling them to obtain a Single Registration Number (SRN).

A dedicated website is live here




Registration, however, is not currently mandatory, and this is causing many companies confusion and sluggishness in complying.

Getting ahead of this incoming regulation will help companies navigate it more easily and waste less time down the line with complications.
Assion is therefore proactively providing support to our client companies in managing this new requirement and helping ensure their registration with EUDAMED is smooth. 

If you would like Assion to help you take the necessary regulatory steps for implementation, contact us here

Alessandro Bider

Global Business Development

Alessandro has very specific experience and expertise in the multinational Pharma industry, spanning across sales, marketing and international project management areas. Alessandro is well versed at combining a strategic and holistic approach to proactively address client’s challenges. Alessandro understands the value of innovation and new ideas to help meet healthcare companies needs and to support the creation of new opportunities, to exceed the objectives laid out in every project.

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