The European Medical Device Regulation (MDR) comes into effect per 26 May 2021. As a consequence the rules for submission, review en performance of clinical trials with medical devices change.
Trials with a medical device that have been approved by the METc UMCG before 26 May 2021 may continue according to current rules and regulation, with the exception of safety reporting which must adhere to the new Regulation per 26 May 2021 (article 80 MDR).
Trials with a medical device that have been submitted before 26 May 2021 but of which the review has not yet been concluded, must adhere to the new Regulation. There is NO transition period.
To prevent double reviews the METc UMCG has decided as of 1 March 2021 to not accept new submissions of trials that fall under article 62 and 74.2 of the MDR.
From 26 May 2021 trials that fall under article 62 and 74.2 of the MDR may be submitted to the METc UMCG.
Postmarketing clinical follow-up (article 74.1) or other (article 82) trials do not have to be resubmitted after 26 May 2021. Their review can be concluded according to current practise.
Do you have a trial with medical devices in review with the METc UMCG but the review is not yet finisched? The METc UMCG will make every effort to conclude the review as soon as possible.
If you have any questions regarding this post, please contact the secretariat of the METc UMCG (mailto: metc@umcg.nl)