CORE-MD work package and task leaders got together online on 21st January 2022 fostering synergies between the CORE-MD researchers. This meeting aimed at focusing particularly on the progress of methods used to generate clinical evidence for high-risk CE-marked cardiovascular, orthopaedic and diabetic medical devices. The objective will be to carry out cross-cutting qualitative analysis between the different disciplines in terms of timelines when evidence becomes available relative to CE marking, when the complications occur and what the benefits are, how we can measure them, how long they last, etc.
What ground breaking for evidence-based policy-making in the work of CORE-MD is that regulators rarely get this type of evidence-based data, validated systematic reviews about CE-marked devices pre- and post-market.
Research brings up new research questions, such as what the reaction of manufacturers and competent authorities would be to change their protocols and use IDEAL-format studies. This will be explored at a later stage.
The discussions have facilitated several synergising meetings between different tasks to make sure that the project as a whole produces coherent results.
The Coordination Group meets quarterly. Their next meeting will take place in April.
Presentations, recording and the minutes are available in Clinked for the project partners.