DG SANTE performs study on monitoring of availability of EU market medical devices

Article summary

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has been performing a study supporting the monitoring of availability of medical devices on the EU market. This has been taking place through the European Health and Digital Executive Agency. The study started in December 2022 and will be running for 36 months, until December 2025. In the context of the study, a dashboard has been developed, which presents an overview of the data gathered from different stakeholders. Comparable data from previous surveys of notified bodies conducted by the European Commission have been integrated in the dashboard. The dashboard also includes further insights and retrospective corrections reported by stakeholders. In addition, the 8th Notified Body survey was released, analysing the availability of medical devices on the EU market as part of the effort to monitor device availability as Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro...