Guidance for notified bodies on compliance with Article 120 of MDR issued

Article summary

The European Commission has published guidance for notified bodies on the activities they must undertake as part of the appropriate surveillance required by Article 120(2)–(3) of Regulation (EU) 2017/745 (the Medical Device Regulation (MDR)) for devices certified by the notifies bodies under Directive 93/42/EEC (the Medical Device Directive (MDD)) or Directive 90/385/EEC (the Active Implantable Medical Devices Directive (AIMDD)). It outlines what elements must be verified by the notified bodies and sets out the requirements concerning certain manufacturers’ obligations, including in respect to their quality management system.