European Commission Study Monitors Availability of Medical Devices on the EU Market
The European Commission’s Directorate-General for Health and Food Safety (DG SANTE), through the European Health and Digital Executive Agency (HaDEA), has commissioned a study supporting the monitoring of the availability of medical devices on the EU market.
The study began in December 2022 and is planned to run for 36 months, until December 2025.
It has been contracted to a consortium led by the Austrian National Public Health Institute, Gesundheit Österreich GmbH/GÖG, in collaboration with Areté and Civic Consulting.
Purpose of the Study
The study aims to support the monitoring of medical device availability on the EU market.
As part of the project, a dashboard has been developed to present an overview of data gathered from different stakeholders.
The dashboard also integrates comparable data from previous surveys of notified bodies conducted by the European Commission.
Stakeholder Surveys
The study includes several stakeholder surveys.
A survey of manufacturers and authorised representatives was launched at the end of 2023, with results made available in a presentation.
A second survey of economic operators was conducted at the end of 2024, and a third survey was conducted at the end of 2025.
The study also included a survey of health service providers in 2024, covering stakeholders such as health professionals, health institutions and medical device procurement bodies.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the study is relevant because it contributes to the ongoing monitoring of device availability in the EU market.
Manufacturers should pay particular attention to:
market availability trends for medical devices;
data collected from notified bodies and economic operators;
feedback from manufacturers and authorised representatives;
perspectives from health service providers and procurement bodies;
potential evidence supporting future policy or regulatory discussions;
the impact of MDR and IVDR implementation on device availability.
For manufacturers, the study may provide useful context on how regulatory transition, conformity assessment capacity and stakeholder experiences are being monitored at EU level.
