Welcome to the website of the Biomedical Alliance in Europe

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.

We use cookies to improve your experience on our website. By browsing this website, you agree to our use of cookies.