EU Medical Device Regulation (MDR) is intended to govern the production and distribution of medical devices in Europe. One of the key elements within this goal is creation of a European database on medical devices (Eudamed) where all information on the device will be allocated (including such data as the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations of the device, vigilance, and market surveillance).

However, the European Commission should set up, maintain, and administrate the Eudamed to enable:

• the public to be notified on the medical devices in the EU market and be able to check the information on the relevant certificate;
• unique identification number (UDI) assignment to the device;
• the public to be notified on the conducted clinical investigations;
• the proper authorities to perform their activities within the MDR being armed with complete information on the subject.

For the proper function of the Eudamed, the EU Commission has developed a Regulatory document that makes it possible to set up, maintain, and administrate the Eudamed. 

Thus, the document contains provisions on the modes of access for authorised and non-authorised users and differentiates way of access via a restricted website and via a public website respectively. It specifies the conditions and steps on how to get the access via restricted websites, describes the role of the European Medical Device Nomenclature (EMDN) in the Eudamed and assigns obligations within the technical and administrative assistance on Eudamed.

Moreover, the document includes recommendations on potential fraudulent use of Eudamed.

The Regulation became effective in the middle of December, 2021. 

The full text of the Regulation you can find here.

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The information has been prepared by the GMA Consult Group team.‍

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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