The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) – via its European Health and Digital Executive Agency (HaDEA) – commissioned a “Study supporting the monitoring of the availability of medical devices on the EU market”.
The general objective of the study, which started in December 2022 and which will run for 36 months until December 2025, is to support the monitoring of the availability of medical devices on the EU market in the context of the implementation of the regulation 2017/745 on medical devices (MDR) and the regulation 2017/746 on in vitro diagnostic medical devices (IVDR) from the perspectives of key stakeholders. Large stakeholder consultations are planned in the context of this study.
At the end of November 2023 a survey on behalf of the European Commission was launched, asking all manufacturers and authorised representatives of medical devices and IVDs, as well as manufacturers and authorised representatives planning to place products on the EU/EEA market in the next two years, , to respond to the survey.
Link to the survey: https://ec.europa.eu/eusurvey/runner/MfandAR
Survey deadline: 15 January 2024 (23:59 CET)
What does this mean to you?
This survey is vital to obtain information from manufacturers of medical device and in vitro diagnostics to support the monitoring of availability of medical devices and IVDs on the EU/EEA market. Thus, for all MD and IVD manufacturers, this is a call to complete the survey by the deadline of January 15th, 2024.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
