A regulatory affairs review highlights how MDSAP methodology can help French and EU medical device manufacturers structure quality management, internal audits and conformity control under the EU MDR.

Regulation (EU) 2017/745 sets out the European regulatory framework for medical devices, covering market access, economic operators, clinical evaluation, vigilance, PMS, UDI and notified bodies.

The June 2025 report on the coverage of MDR and IVDR designation codes by notified bodies provides an updated view on the availability of designated bodies for specific categories of medical devices and in vitro diagnostic medical devices. It identifies critical areas with lower coverage, such as active implantable medical devices (codes MDA 0101 to MDA 0104) and devices originating from human tissues (MDS 1002), as well as IVDs for blood and tissue typing (codes IVR 0101 to IVR 0202). For medical device manufacturers seeking certification under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, analysis of these codes is essential to plan the submission of applications to notified bodies with adequate coverage.