New Class I Article 120 (3) and (4) guidance released
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, …
New Class I Article 120 (3) and (4) guidance released Read More »