Research Roadmap

Clinical investigations involving medical devices are subject to specific rules for submission, assessment and conduct. These rules are outlined in the EU Medical Device Regulation (EU No. 2017/745, MDR), which has been in effect since 26 May 2021.

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;
• The Medical Technology Department's webpage.

What is a medical device?

A medical device is any instrument, appliance, apparatus, software, implant, reagent, material or other item intended by the manufacturer for human use, either alone or in combination, for one or more of the following 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 physiological/pathological process or physiological/pathological condition;
• In vitro investigation of specimens taken from the human body (e.g. organ, blood or tissue samples), provided its principal intended effect in or to the human body is not achieved by pharmacological, immunological or metabolic means. Although means of this kind may play a supporting role.

Additionally, the following products are classified as medical devices:

• Aids for controlling or supporting fertilisation;
• Special products for cleaning, disinfecting or sterilizing equipment;
• Products included in Annex XVI of the MDR, such as contact lenses, implants, wrinkle fillers, equipment for lipolysis/liposuction, equipment for skin treatments using electromagnetic radiation, and equipment for brain stimulation.
• Some products that are not intended for medical purposes but are similar to medical devices are also covered under Annex XVI of the MDR.

Whether research involving medical devices is subject to the MDR depends on the objective of the research. The MDR defines a clinical investigation as a systematic study of one or more participants to assess the safety and/or performance of a device.

Categories

Different categories of studies fall under the MDR, each with its own requirements and ethical review process:

• Article 62: research for conformity assessment (to obtain CE-marking and product development);
• Article 74.1: research involving a CE-marked medical device (within its intended use) as part of a post-market clinical follow-up (PMCF), where participants undergo supplementary invasive or stressful procedures;
• Article 74.2: research for conformity assessment outside intended use (expanding CE-marking);
• Article 82: research that does not fall under articles 62 and 74. For example: research into custom made medical devices, medical devices manufactured and used exclusively within Amsterdam UMC, or investigator-initiated research with CE-marked medical devices.

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

Investigational Medical Device Dossier (IMDD)

An IMDD contains technical documentation about the medical device. The CCMO provides a model IMDD on their website.

Amsterdam UMC provides documents to compose an IMDD-light version, including a manual, example, risk analysis and template.

For further questions and advice, contact adviesmedischehulpmiddelen@amsterdamumc.nl

Internal registration of medical devices

Medical devices must be registered with different, sometimes more than one, departments in Amsterdam UMC.

Medical devices subject of a clinical investigation

• If Amsterdam UMC is the manufacturer or modifies the medical device, it must be registered via this report form, following an abbreviated procedure. Additionally, an IMDD must be compiled for submission to the MREC (see above).

• If Amsterdam UMC is not the manufacturer, all devices that are the subject of a clinical investigation must be registered at the medical device office via adviesmedischehulpmiddelen@amsterdamumc.nl. A purchase file is also required. The required steps for completing this process are desribed in the following documents:

  • Medical devices/technology: Purchase file
  • Medical devices/technology: purchase file, work instructions for users

Medical devices not subject of a clinical investigation

Medical devices used for study procedures, but not the subject of a clinical investigation, must still be registered through a purchase file. The required steps for completing this process are desribed in the following documents:

• Medical devices/technology: Purchase file
• Medical devices/technology: purchase file, work instructions for users

Purchase file

Note that a purchase file is mandatory for every medical device or piece of medical software, regardless of whether it has a CE-mark, is used within its intended purpose, is provided by an external manufacturer, or is borrowed or purchased.

The assessment of the purchase file does not have to be submitted to the MREC. Both processes can run in parallel to minimize delays. However, It is strongly recommended to complete the purchase file before the MREC submission to ensure that once the study obtained MREC approval, the medical device is also approved for use.

For questions or assistance, contact adviesmedischehulpmiddelen@amsterdamumc.nl