ARTICLE SUMMARY:
Medical Device and IVD Regulation submission and review activity is increasing, but challenges remain. Here's a few graphical takeaways based on outcomes from recent European Commission surveys of notified bodies and manufacturers.
Upwards of three-quarters of notified bodies continue to report that most MDR and IVDR applications are initially coming in from manufacturers missing too many required components to start review. That, plus data on how long it takes the bodies to complete review on applications once they are ready for consideration and on the extent of companies that have stopped or plan to stop production on devices in response to the EU regulations in this latest edition of Market Pathways Scorecard.
