Clinical trials involving medical devices

  • WMO

For clinical trials involving medical devices specific information is needed in the protocol and also in the MREC standard research file for submission. Since 26 May 2021, the new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic is fully applicable to harmonise laws and regulations around marketing and using medical devices.

For more information, see the policy paper “Clinical investigations with medical devices” the Amsterdam UMC factsheet clinical research with medical devices, the roadmap for medical devices and the webpage of the department Medical Technology.

What is a medical device?

A medical device is an instrument, appliance or apparatus, software, implant, reagent, material or other item that is intended by the manufacturer for human use alone or in combination for one or more of the following specific medical reasons:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of illness;
  • diagnosis, monitoring, treatment, alleviation or compensation of injury or disability;
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or a physiological or pathological condition;
    • provision of information from in vitro investigation of specimens taken from the human body, including organ, blood or tissue samples, whereby the principal intended effect in or to the human body is not achieved by pharmacological, immunological or metabolic means, although means of this kind may be used in a supporting role.

The following products are likewise designated as medical devices:

  • aids for controlling or supporting fertilisation;
  • special products for cleaning, disinfecting or sterilising equipment, and products included in Annex XVI of the MDR. These are such products as contact lenses, implants, wrinkle fillers, equipment for lipolysis or liposuction, equipment for skin treatments using electromagnetic radiation and equipment for brain stimulation.

In addition to these definitions, Annex XVI of the MDR includes certain products that also explicitly fall under the MDR. These are products that are not intended for medical purposes but are similar to medical devices.

Whether a study falls under the MDR depends on the objective of such research involving medical devices. A clinical trial is defined by the MDR as a “systematic study of one or more participants carried out to study the safety and/or performance of a device”.


There are different categories of study that fall under the MDR, each with its own article, accompanying requirements and method of ethical review of the trial.

  • Article 62: Research in the framework of conformity assessment (obtaining CE mark/product development)
  • Article 74.1.: Clinical research involving a medical device with CE mark (within intended use) as part of a post-market clinical follow-up (PMCF) in which participants undergo supplementary invasive or stressful procedures.
  • Article 74.2 : Clinical research for conformity assessment outside intended use (extended CE mark)
  • Article 82: Clinical research into medical devices that does not fall under articles 62 and 74. For example, clinical research into custom made medical devices, medical devices whereby the hospital is the manufacturer and the device will only be used in that institution or by investigator initiated research with CE marked medical devices.

For studies that fall under articles 62 and 74.2 the MREC requires technical advice as part of your research file for submission.

Investigational Medical Device Dossier (IMDD)

An IMDD contains technical documentation about the medical device. Amsterdam UMC provides some documents to compose an IMDD light.

  • Click here for a manual
  • click here for an example
  • Click here for the risk analysis
  • Click here for the IMDD-light

    For further questions and advice, please contact

    Note: The CCMO also provides a model IMDD  on their website.

      Internal registration of medical devices

      There are different, sometimes more than one, departments to register your medical device.

      Devices subject to a clinical trial

      Devices not subject to a clinical trial

      Medical devices used for research procedures, but which are not subject to a clinical trial, must be registered through a purchase file the steps required to go through are described in K2.iProva;

      Purchase file

      Please note that the purchase file applies to every medical device or piece of medical software: so whether the device has a CE mark or not, is used within its intended use or not, is provided by an external manufacturer, borrowed or purchased, the purchase file is mandatory in every instance.

      It is important to know that the assessment of the purchase file does not have to be sent together with the MREC application. The two procedures can therefore run parallel, so that the delay is as short as possible. It is highly recommended to complete the purchase file before submitting the MREC application. To make sure that when the study is approved by the MREC, the use of the device is also approved.

      For questions or advice please contact