09.01.2025
To the attention of interested persons
The European Commission posted two public consultation for economic operators (manufacturers, authorised representatives, importers or distributors) on its website (https://ec.europa.eu/eusurvey/runner/2024MDAvailabilityMFARIMDBsurvey) regarding medical devices and in vitro diagnostic medical devices within the trial monitoring the availability of medical devices on the European Union market (HaDEA/2021/P3/03).
More information on participation, confidentiality and other details related to this trial are available at: https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en and https://ppri.goeg.at/Study_MD_Availability.
Deadline for participation: 28 February 2025.
The purpose of this trial is to collect information about the transition of devices to EU regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). The questionnaire also contains questions regarding the undergoing targeted assessment, carried out by the European Commission. The first public consultation has provided essential data and the results are accessible using an interactive tool and as a PPT presentation.
The trial is led by Gesundheit Österreich GmbH (Gög), the Austrian National Public Health Institute, in collaboration with Areté and CivicConsulting and committed by the European Commission – the Directorate-General for Health & Food Safety (DG SANTE) through the European Health and Digital Executive Agency (HaDEA).