Upon request by the European Commission, a survey intended for economic operators is ongoing to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of European Regulations 2017/745 (MDR) and 2017/746 (IVDR).
This survey aims to identify obstacles that could affect availability of devices and/or impair the conformity assessment process, pointing to potential solutions.
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 survey to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of Regulation (EU) 2017/745 (MDR) on medical devices (MDs) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices (IVDMDs).
This is already the second survey of economic operators as part of the "Study supporting the monitoring of availability of medical devices on the EU market", which started in December 2022 and will be running until December 2025.
Implementation
The study 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.
All economic operators will be consulted in order to identify obstacles that could affect availability of devices and/or impair the conformity assessment process, pointing to potential solutions. Other surveys aimed at notified bodies, healthcare professionals and patients have already been carried out.
Confidentiality
Any specific information collected at individual company level will be kept confidential and will not be disclosed, in compliance with EU competition law. Only company-neutral data will be integrated in a public dashboard and published in summary reports.
How to participate?
Are you a manufacturer, an authorised representative, an importer or a distributor of MD and IVD? Take part in the survey until 28 February 2025.
Webinar
Meet the study team and find out more about the context and the structure of the survey:
• 16 January 2025 (11am–12pm);
• no registration;
• via Zoom.
For further information
SANTE-MED-DEV@ec.europa.eu
Friederike.Windisch@goeg.at (Friederike Windisch, study's project manager)