The study is focusing on two key stakeholder groups, manufacturers and authorised representatives. The outcome of which, is to effectively monitor the availability of medical devices (including in-vitro diagnostic devices) on the EU market and the insights from these two key stakeholders are deemed essential. This study will be conducted repeatedly over a three year period starting December 2023.
The first online survey was published December 1st 2023 and as mentioned it is specifically designed for manufactures of medical devices and in-vitro diagnostic devices, as well as authorised representatives and for MDR & IVDR compliant devices.
The survey is quite detailed and asks for a lot of data, nonetheless the EU Commission is hoping for the support of manufacturers and authorised representatives so they may gain the necessary information to have a clear understanding of the situation concerning the transition to the MDR & IVDR regulations.
We would encourage all relevant stakeholders to complete and submit the survey, the deadline for completion is January 15th 2024.
Click here to take the survey.
