Medical devices and in vitro diagnostic medical devices

Draft Commission Implementing Regulation laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council; (13 page(s), in English)

The notified draft sets out requirements for the harmonised applications of provisions for notified bodies established in Annex VII to Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostics. In particular, those provisions cover quotations, timelines for notified bodies to carry out conformity assessment activities, monitoring of notified bodies' performances as regards timelines and costs and re-certification.