Medical device regulation as of 26 May 2021

On 26 May 2021, the European Medical Device Regulation (MDR) will take effect. What are the points for attention for the submission of new research with a medical device (including apps or software)?

New adult subject information template

A new version of the template for a Subject Information Sheet for research subjects > 16 years of age (adults) is available on the CCMO website.

Telephone consultation option resumed

Secretariat of the Research Review Department can be reached by telephone again as of 31 August 2020

2019 Annual Report of the MREC Utrecht

Annual report 2019 MREC Utrecht

Coronavirus: Amended procedures

Due to the coronavirus outbreak, the Research Review Department has amended its procedures. Please check this page regularly for updates.

Research with medical devices: MDR implementation postponed until 26 MAY 2021

Research with medical devices: MDR implementation postponed until 26 MAY 2021

Zoek jij een tijdelijke administratieve uitdaging in een academisch ziekenhuis, werk je graag in een team en heb je affiniteit met wetenschappelijk onderzoek?

Practice with the Voluntary Harmonisation Procedure (VHP)

As of 1 November 2019, applicants submitting a research proposal will have up to 4 weeks to respond to questions received from the MREC. Until then the maximum period is 8 weeks. The new, shorter period will promote quick and efficient processing of research proposals. In addition, with the new period we are anticipating new EU legislation that will be implemented in 2020 and that will require shorter, stricter time frames.

As of 24 September 2019, meetings of Chamber M will be held on Tuesdays instead of on Mondays (like before: in odd weeks). Meetings of Chamber D will still be held on Tuesdays in even weeks.