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MDCG 2021-1 guidance during the absence of EUDAMED

On 26 February 2021, the European Commission released MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional.

This document provides guidance on the application of certain MDR provisions during the absence of EUDAMED.

The MDR determines that until EUDAMED is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 123(3)(d) regarding the exchange of information. This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of Directives 90/385/EEC and 93/42/EEC.

The guidance breaks down the EUDAMED-related provisions of the MDR and provides alternative solutions to meet the requirements for the submission or exchange of information.

You can find the MDCG 2021-1 guidance here.