Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements
This is what exactly the NC says:
... "The procedure on Post-Market Surveillance System was provided. Although it refers to the need to establish “a post market surveillance plan for each product”, it does not introduces the notion of Post Marketing Clinical Follow-up as required by the Medical Device Directive in it Annex X - section 1.1.quater"
... What I figured is that they needed a PMCFU to be a part of our PMS, but as I said in Annex X though is does not state explicitly, it does state that this is required for Class III and implantables, so should I just add a procedure for clinical evaluation or should I talk to them and say that our product is Class IIa, does not require clinical evaluation?