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News overview

News overview

Medical device regulation in effect

On 26 May 2021, the European Medical Device Regulation (MDR) took effect.

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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.

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Telephone consultation option resumed

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

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2019 Annual Report of the MREC Utrecht

Annual report 2019 MREC Utrecht

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Coronavirus: Amended procedures

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

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

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

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Practice with the Voluntary Harmonisation Procedure (VHP)

Practice with the Voluntary Harmonisation Procedure (VHP)

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Change to response time as of 1 November 2019

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.

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Change to the MREC’s meeting schedule at the end of September 2019

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.

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Updated WMO / Non-WMO Form

A new version of the so-called WMO / Non-WMO Form is now available. The new version more specifically asks for information based on which the MREC will decide on the applicability of the WMO. Use of the new form is therefore recommended.

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