The BioMed Alliance submitted written recommendations, in response to the call for consultation on Scientific bodies under the new EU legislative framework. The new  EU Medical Device Regulation 2017/745 (MDR) foresees an independent mechanism of scrutiny of conformity assessment of certain high-risk medical devices (class III and IIb) which is going to be conducted by expert panels. The expert panels will address a range of clinical areas of relevance such as:

  • Provision of advice in relation to implementation of the EU Medical Device Regulation 2017/745 (MDR), and of the EU In-vitro Diagnostics Regulation 2017/746 (IVDR)
  • Scrutiny of the clinical evaluation dossiers of certain high-risk medical devices

The BioMed Alliance’s response can be found here.

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