QMS Certification, EU MDR

[MDMalt]

Looking for input from people with EU MDR Stage 1/2 audit experience. (QMS) [Iso13485 certified org]

Would it be expected for the QMS to cover Art 62-80/Chapter 6 and annex XV if no clinical investigations are planned/foreseen.
Would simply capturing the requirements in the QMS be considered sufficient ( for stage 1) ?
Considering no imminent patient risk (no studies planned), would this gap be considered minor even if it spans the entire topic/area of Clinical Investigations?

 

[Cloud808]

We have completed stage 1 & 2 audits. Our QMS did include the requirements related to whether or not CI should be performed and a statement that if CI not required a rationale shall be documented (Article 61). Our QMS did not cover the requirements within Art 62-80 or Annex XV.

Wishing you success with your certification efforts!

 

[Philip B]

You need to document your rationale for not carrying out clinical investigations, the clinical evaluation report is probably the best place to do this. Once that is documented, I can't see any need for your QMS to cover the articles you mention. Make sure your rationale is thorough; if there are any clinical risks not adequately addressed then you will probably need to do a clinical investigation. Hope this helps.