ARTICLE SUMMARY:
The European Commission is expected to release a public dashboard this summer with regularly updated metrics on how notified bodies are performing on MDR and IVDR conformity assessments. Exactly what information will be disclosed remains to be seen; industry representatives hope it will clarify how much time bodies are spending on innovative versus legacy devices, and on SMEs versus large medtechs.
More regularly updated information about notified body capacities and assessment timelines under the EU Medical Device and IVD Regulations could be available soon via a planned public dashboard.
The dashboard will feature data collected from regular surveys to MDR and IVDR notified bodies conducted as part of a European Commission-funded initiative to monitor medical device availability and obstacles.
