Open consultation

Health institution exemption for IVDR/MDR

Summary

MHRA is 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).

This consultation closes at

Consultation description

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.

Documents

Health institution exemption draft for public consultation

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Ways to respond

Complete a response form and

Email to:

hie@mhra.gov.uk

Published 22 January 2018
Last updated 22 January 2018 + show all updates
  1. Updated to include draft health institution exemption
  2. First published.