The MDCG has finally published it guidance MDCG 2020-2, which covers transitional provisions under article 120 of the MDR. It sets out important procedural requirements for a class I manufacturer about how to document things, what the state of the technical file and QMS should be and what the declaration of conformity should look like, because these are things that manufacturers of class I devices often don’t get right.
This guidance is important for all manufacturers whose medical device(s) would be up-classified under the MDR, such as including but not limited to (standalone) software, substance based devices and inhalers.