Research with Medical Devices

Research with Medical Devices

On 26 May 2021 the European Medical Device Regulation will enter into force (EU Regulation no. 2017/745 (MDR)). As a result of this, the rules for the submission, review and conduct of clinical research with medical devices will change on that same date.

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

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 (MDD and, from May 2021, MDR), please substantiate this properly.

Which documents are required? uitklapper, klik om te openen

The following documents are required if the device (e.g. app) meets the criteria for research with a medical device:

  • Description of the device (for an app: the software), preferably in an Investigational Medical Device Dossier (IMDD). For a medical device with a very low risk profile it may be decided, in consultation with the institution’s technical support department, that a concise IMDD will be sufficient.  
  • Assessment of the IMDD by the institution’s technical support department
  • Other documents in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO)

Devices for the investigator

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

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