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 for a class I manufacturer about how to actually 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 do not right.
Contents of the declaration of conformity: guidance on the content of the Declaration of Conformity can be found, inter alia, in the “The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C272/01)” and the standard EN ISO/IEC17050-1. That guidance was always there already (and this is yet another reason to read the Blue Guide, which everybody should do – it contains many of the answers that people keep asking me).
If you do amend your technical documentation and/or DoC, mind you that
“Necessary amendments/updates to the technical documentation should be done in a transparent manner. Both the changes and the dates of when the changes were made should be recorded. On the basis of the Declaration of Conformity and the corresponding technical documentation, the manufacturer should be able to demonstrate that the Declaration of Conformity was lawfully issued before 26 May 2020 and that, subsequently, there are no significant changes in the design or intended purpose in the meaning of Article 120(3) MDR.”
Also this requirement should not be a surprise, but here you have it again.
For which manufacturers is this important? This is important for all manufacturers whose medical device would be up-classified under the MDR, such as including but not limited to (standalone) software, substance based devices and inhalers.
Can’t figure it out? This is the moment to dare to be wise and really understand this stuff, or ask someone to help you understand. That could be me or any other good medical devices expert out there. It’s busy times though as you may have noticed, so ask sooner rather than later.