New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements
I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.
The new guidance
The MDCG has now (finally) published its guidance MDCG 2020-2 on the subject, which confirms everything in that blog in terms of the mechanics of timing, but adds important procedural requirements [...] « Read the rest of this article on