Survey of medical device manufacturers to assess the impact of the new regulation

The European Commission has launched a survey to assess the impact of the new regulation on medical devices and the availability of such devices on the EU market. The survey is targeted at all manufacturers and authorised representatives of medical devices and in vitro diagnostic medical devices already on the market in the EU. Responses are also being sought from manufacturers that intend to place new MD or IVD regulation-compliant medical devices on the EU market in the next two years. 

All individual data collected will be treated as confidential. The results of the survey will only be published as aggregated data. 

Please respond to the survey by 15 January 2024

Questionnaire (EU Commission) 

Fimea will send a link to the questionnaire by e-mail to all operators registered as manufacturers or authorised representatives of medical devices in Finland. Please respond by 15 January. 
Responding to the survey is important to get as comprehensive a picture as possible, so that the obstacles faced by manufacturers can be identified and the right support can be provided. The Medical Devices Regulation (MD Regulation (EU) 2017/745) and the Regulation on In Vitro Diagnostic Medical Devices (IVD Regulation (EU) 2017/746) have brought major changes to the medical devices market in the European Union (EU).

The responses to the survey will also provide important information to support availability management and preparedness across the health care sector.  

Read more: 

EC Medical Devices Sector (News Announcement 1 December 2023)
MD Regulation (EU) 2017/745  
IVD Regulation (EU) 2017/746   
Fimea: Medical devices