When the Commission recently published the Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment on 11 January, there was much rejoicing in the medical devices community. Yay!
It looked like one of the big stumbling blocks of hold up of issuance of MDR certificates was finally cleared. But, this is actually not the case. [...] « Read the rest of this article on