MDCG issued its first 2021 guidance that clarifies to Member States and other parties on the application of certain MDR provisions during the absence of EUDAMED. The guidance describes harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional. Many important aspects have been clarified, such as:
- Alternative solutions to submit and/or exchange information for Registration of devices (as per art. 29 of the MDR), should be carried out by the manufacturer, based on the following instructions:
- As soon as the functionality is . . .
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- As soon as the functionality is . . .