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Four opinions issued by expert panels July22-June23

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has recently published its annual report on devices subject to the clinical evaluation consultation procedure (CECP), available from here.

Titled ‘Commission Staff Working Document: Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54(4) of Regulation (EU) 2017/745 on medical devices (July 2022-June 2023)’, the report identifies from Notified Body data that 35 CECP applications were submitted to the Secretariat of the expert panels during the year, four of which resulted in expert opinions being provided. This compares with six expert opinions being provided during the previous 12 months.

All four expert opinions were expressed on Class III implantable devices, these being in the following EMDN categories:

  • P0704: Vascular and cardiac endoprostheses
  • P9002: Surgical meshes
  • P0901: Shoulder prostheses
  • J0190: Implantable cardiac devices

The secretariat did not receive any justification from NBs not following the advice provided by the expert panel.

Copies of the opinions rendered by the expert panels are available from this page of the Commission website.