This tipsheet is designed to guide investigators in setting up their medical device trials under the Medical Device Regulation (MDR). It provides information about which steps to take and and other local procedures to consider.

Step 1: Does my trial actually fall within the scope of the MDR?
The definition of “clinical investigation” according to MDR:

Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

Scientific research in which a medical device with a CE marking is used within the intended purpose and in which the safety, performance and/or effectiveness of the medical device itself is not investigated, falls outside the scope of the MDR.
Note that these trials may still fall within the scope of the WMO with its own submission procedure, see the website METC Amsterdam UMC.

Step 2: Yes, the MDR applies to my trial, but which article?
The MDR has four categories of clinical investigations, each with its own article, associated requirements and method of ethical review of the trial:

  • Article 62
    Clinical investigation in the context of conformity assessment (obtaining CE mark/product development)
  • Article 74.1
    Clinical investigation of a CE marked medical device (within intended purpose) as part of a post-market clinical follow-up (PMCF) in which participants undergo additional invasive or burdensome procedures.
  • Article 74.2
    Clinical investigation as a conformity assessment of a medical device used outside its intended purpose (expand CE mark)
  • Article 82
    Clinical investigation on medical devices not covered by articles 62 and 74. For example, clinical investigation of custom-made medical devices, medical devices where the hospital itself is the manufacturer and the device is only used in its own institution, researcher-initiated investigations with CE-marked medical devices or researcher-initiated investigations with non-CE marked devices outside of their intended use in which a conformity assessment is not the context of the clinical investigation

To determine which category applies to your trial, see the flowchart on the CCMO website.

Step 3: CCMO Validation yes or no?
The MDR stipulates that some clinical investigations must be validated before they can be assessed by a review committee.

  • Yes in case of obtaining or extending a CE marking (or Article 62 and 74.2).
    The CCMO assigns the assessment file to a specific review committee (MREC or CCMO) for further assessment. When submitting the file, a preferred review committee can be indicated.
    Investigations no longer need to be reported to the IGJ, this is done by the CCMO as part of the validation process.
  • No Article 74.1 and 82. Submit your assessment file to an accredited MREC. Submission to MREC Amsterdam UMC is done via the submission portal Research Manager.

In addition, if there are any doubts about the need of a CCMO validation you can make use of the following tool: Committee Finder (

Step 4: Is there an overview of documents to be submitted for clinical investigations on medical devices?
For an overview, see the website of the CCMO and the METC Amsterdam UMC.

For investigations that fall under articles 62 and 74.1, in which Amsterdam UMC is the manufacturer of the medical device, please contact the service desk: before the Investigational Medical Device Dossier (IMDD) is drawn up. A manual on how to write an IMDD can be found on the website of the METC.

Step 5: Are there any specific procedures that must be followed for implementation within the Amsterdam UMC?
Medical devices that are used in trials must be reported. This not only concerns the medical device that is the subject of the trial, but also equipment that is, for example, obtained on loan for the duration of the trial (such as a blood pressure monitor).

All medical devices that are developed or adapted within Amsterdam UMC for patient
care or for scientific research must be registered using this report form in K2.

In addition, all devices that are subject to a clinical trial must be registered
at the medical device office via It is also important that the procedure for the purchase and import of medical devices is followed when every medical device is imported into the hospital (CE marked or not).

These procedures are mandatory before an trial can start.

Please be referred to the Amsterdam UMC policy for clinical scientific research with medical devices and a factsheet for clinical scientific research under the MDR, for more additional information and guidance.

Additional information
Do you have any additional questions or would you like additional advice about the MDR? Contact or visit the Research Roadmap and the medical technology theme page.