We are conducting a survey on behalf of the European Commission (DG SANTE/HaDEA) to collect information and data on the status of the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/745 (IVDR).
We kindly ask all manufacturers and authorised representatives of MD and IVD, including those planning to place products on the EU/EEA market in the next two years, to respond to the survey!
The aim is to get a realistic picture of the status of the MDR/IVDR implementation and your feedback is therefore of utmost importance! Please find attached the pdf version of the survey and the endorsement letter from the European Commission. The survey builds upon previous surveys conducted in this field and was developed together with DG SANTE and the MDCG TF on certification capacity monitoring and industry representatives.
Link to the survey: https://ec.europa.eu/eusurvey/runner/MFandAR
Survey deadline (extended): 31 January 2024 (23:59 CET)
Kindly provide only ONE answer per company and question.
Data protection: We will keep any company-specific information (raw data) collected strictly confidential and under no circumstances will we disclose individualised company-level information. The aggregated, company-neutral data will be fed into a public dashboard and will be analysed in the form of synopsis reports.
Webinar with the study team with details on the survey background and the survey structure:
Thursday, 7 December 2023, 1-2pm CET (no registration needed) - recording available.
Contact: If you have any queries, please contact the study team: medical.devices@goeg.at (Ms Friederike Windisch, Ms Nina Zimmermann)
This survey is of crucial importance and we need your support!
Last update: 07 December 2023