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. It describes harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.
The MDR stipulates 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 MDR and provides alternative solutions to fulfil the requirements for submitting or exchanging information.
What does this mean to you?
If you are a Medical Device manufacturer and want to know how to best address the EUDAMED information exchange requirements prior to EUDAMED being fully functional this guidance is a must read.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.