ChrisM
Quite Involved in Discussions
Reading through the EU Medical Device Regulation 2017/745, for a Company designing and manufacturing a Class 1 device that is non-sterile, non-invasive and non-measuring, it appears that in order to prepare a DoC under Article 52 paragraph 7, we only need to prepare product Technical Files and conduct Post-Market activities, as per Annexes II and III. Is my reading and interpretation of the Regulations correct, that we are not required to have a documented Quality Management System, let alone a certified QMS?