This document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.
The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the MDR effectively while minimising any potential additional burden on the parties concerned. 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. In doing so, this guidance takes into account the decision of the Medical Device Coordination Group in its meeting of 12 March 2020 where the group agreed that the Commission makes available to Member States each EUDAMED module as soon as it is operational. This approach also has an impact on the means by which relevant information collected under the MDR will be made available to the public, which shall take place on a gradual basis.
The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the requirements under the MDR, including those contained in the provisions referred to in Article 123(3) letters (d) and (e) MDR.
Whenever this guidance makes reference to CircaBC6 as alternative solution, the Commission and other relevant parties should endeavour to make use of already existing CircaBC directories to the extent that this is possible and appropriate.
Parties should also take note of the MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.
MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional