• Regulatory NewsRegulatory News

    MDCG Updates Q&As on Requirements for Notified Bodies

    The European Commission’s Medical Device Coordination Group (MDCG) recently added about six pages worth of questions and answers (Q&As) to its document on requirements relating to notified bodies (NBs). The update to the document, which was first released in June , comes as five NBs have been designated under the Medical Device Regulation (MDR), while one NB has been designated under the In Vitro Diagnostic Regulation (IVDR). Most of the information related to o...
  • Regulatory NewsRegulatory News

    EC Unveils Designating Authority’s Final Assessment Form Under MDR, IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR), which takes effect next May, and the In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022. The form includes space to describe the assessment carried out by the designating authority and whether all correctiv...
  • Regulatory NewsRegulatory News

    Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline

    European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues. According to the European Association for Medical Devices of Notified Bodies (Team-NB), 84% of notified bodies intend to submit their application in November, 8% intend to submit in December and 8% next year. More than half of the no...