Workshop on “Methodologies for evaluating high-risk medical devices: a matrix of study designs”
The CORE-MD consortium have produced extensive reviews of clinical evidence and scientific validity of different study designs and evaluation methodologies along the medical device life-cycle – from pilot observational studies to large randomised controlled trials and including new methodologies. These results are being synthesized by the consortium partners to create final recommendations to EU regulatory bodies and the clinical community. This task is also meant to identify gaps in the EU regulatory framework and recommend where developments and/or regulatory guidance and/or future research is indicated. EU national regulatory agencies are thus invited to participate in a workshop on the 21st of November 2023 to discuss them and provide inputs. In addition, insights obtained during the previous meetings with regulators at the European Commission MDCG CIE and other relevant working groups will be also taken on board.
Finally, the CORE–MD consortium will present its conclusions and seek regulators’ endorsement of its summary recommendations concerning a ‘Matrix’ of types of methodologies to generate clinical evidence classified according to their reliability and utility at different stages of the development and approval of new devices, and also concerning needs for future research and development in EU regulatory science. The conclusions from this workshop will be used to refine the CORE-MD official documents, and final recommendations will be submitted and published in 2024.
Date and time: 21st November 2023, 9:00 – 17:00 CET
Workshop format: hybrid
Chairs: to be confirmed
Venue: European Society of Cardiology, rue de la Loi 34-36 – 1040 Brussels.
Note: the event is not open to the public.
