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Dec 15, 2020 Robert Fenton

First Module of EUDAMED on Actor Registration Open

The European Commission has launched registration for the first module of the future European Medical Device Database. MDR EUDAMED is the first IT system developed by the European Commission to implement and manage Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

This is the first of six EUDAMED modules.

The European Commission, in agreement with the Medical Device Coordination Group (MDCG), will soon make available additional modules on a gradual basis. Moreover, the European Commission is not in a position to require the use of the module until EUDAMED is fully functional in accordance to the Medical Device Regulation (MDR). The registration module enables operators to submit, by the means of an actor registration request, the information needed to access and obtain a Single Registration Number (SRN).

Every economic operator, including EU and non-EU manufacturers, authorized representatives, systems/procedure pack products and importers must register as an actor in EUDAMED. The process is simple.

Documents to Provide With Actor Registration Request

1. Declaration on Information Security Responsibilities: Actors must upload a signed Declaration on Information Security Responsibilities.

2. Mandate Summary Document: To register in EUDAMED, non-EU manufacturers must submit a Mandate Summary Document. For those already registered in EUDAMED, all persons who intend to act on behalf of the actor must enter an Access Request

Technical Resources and Documentation

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As an industry-leading QMS provider, Qualio powers major medical device manufacturers in the EU and beyond. Gain visibility into your teams, processes, and data. Additionally, Qualio makes it easy to streamline product development as you scale, including premarket activities, registration, and regulatory compliance.

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Published by Robert Fenton December 15, 2020