Research with medical devices

Research with medical devices

On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745 (MDR)) entered into force. As a result, the rules for submission, review and conduct of clinical research with medical devices have changed.

As soon as a study relates to the safety or performance of a medical device (also software or app) the MDR-regulation applies.

General information can be found on the CCMO website 'clinical investigations with medical devices'.

When in doubt, please seek advice from the relevant department of your own institution.

Antoni van Leeuwenhoek: MyAntonet
Princess Máxima Center: Trial and Data Center (TDC)
UMC Utrecht: Cluster MT&KF (email)

Submission of the file uitklapper, klik om te openen

First consult the CCMO website to determine whether submission should be made to the CCMO or to the MREC.

It is important to clearly describe the purpose of the research. If you believe, for example, that a particular app or other device does not fall within the scope of the MDR, then please substantiate this.

What documents are needed uitklapper, klik om te openen

Please refer to the CCMO website and the page 'Documents and forms' for the required documents. 

Resources for the investigator uitklapper, klik om te openen

Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek

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