Notified Bodies (NB) Task Force
Mission: Systematic engagement with NBs to advance in silico trials in Europe
Within the policy development working group of the Avicenna Alliance, the Notified Body (NB) task force aims to engage with NBs to increase acceptance of in silico evidence in Europe, provide NBs with guidance documents and offer them assistance in the review process of digital evidence.
Goals
- Increase acceptance of digital evidence in Europe and by the NBs.
- Provide guidance to members submitting digital evidence in Europe.
- Offer assistance to NBs in their review process of digital evidence by engaging members to act as Subject Matter Expert (SME).
Recent achievements
- Whitepaper published beginning 2021 mapping the various NBs designated under the EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746) together with the perception of in silico evidence among them
- Engaging with several NBs as well as The European Association for Medical devices of Notified Bodies (Team-NB) to identify the current status, gaps and challenges in the acceptance of in silico evidence by NBs
- Ongoing collaboration with standardisation bodies to develop & harmonize guidance documents (e.g. DIN)
