Publication of rules on designation of expert panels under the Medical Devices Regulations

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision) laying down rules on designation of expert panels in the field of medical devices. These expert panels are to be designated to provide scientific, technical and clinical assistance to the Commission, the Medical Device Coordination Group (MDCG), Member States, notified bodies and manufacturers under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These expert panels will also be consulted by notified bodies as part of the conformity assessment of high-risk medical devices.

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