We want to know what you think
We would appreciate your help in developing guidance for health institutions wishing to apply the exemption to the new in vitro diagnostic medical device regulation (2017/746) and the new medical device regulation (2017/745). In particular, the provisions of Article 5(5) of both IVDR and MDR
Please answer those sections of the questionnaire that are relevant to you. In addition, you can provide general comments not covered by the questionnaire.
This consultation aims to gather views from a broad range of stakeholders.
To get the best range of views and allow health institutions to test and model the guidance, this is a longer consultation which will run until 31st March 2019.