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Research with Medical Devices

Research with Medical Devices

On 26 May 2021 the European Medical Device Regulation (EU Regulation no. 2017/745 (MDR)) took effect. As a result of this, the rules for the submission, review and conduct of clinical research with medical devices are changed.

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

You will find general information on the CCMO website under “Research with a medical device
If you have any doubts, you can ask the technical support department of your own institution for advice.

  • Technical support at UMCU: Medical Technology & Clinical Physics Cluster of UMC Utrecht.
  • Technical support at the Princess Máxima Center: TDC. 

Submission of the file uitklapper, klik om te openen

Please visit the CCMO website (information in Dutch) to dermine whether the study needs to be submitted to the CCMO or a MREC first! 

It is important to clearly describe the purpose of the research. If in your opinion a certain app or other device does not fall within the scope of the legislation of the MDR, please substantiate this properly.

Which documents are required? uitklapper, klik om te openen

Please visit the CCMO website (information in Dutch) and our website for the required documents. 

Devices for the investigator

Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology

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