When does the MDR apply to research

The EU Medical Devices Regulation applies to your research if you are studying the safety and/or (clinical) performance of a medical device. If your research involves the use of a medical device, but that device is not the subject of investigation, the MDR does not apply, but other regulations, including the WMO may still apply.

For example, if you’re evaluating the performance of a wearable device to accurately measure heart rate and blood pressure, the MDR applies. If you’re using the wearable to measure blood pressure and heart rate as a proxy for emotional response, but the performance, safety and effectiveness of the wearable itself are not under study, the MDR does not apply.

What constitutes a medical device?

This CCMO page (in Dutch and in English) explains the MDR definition of a medical device. Additionally, some devices without medical purposes are subject to the MDR and sometimes software can be considered a medical device.

Examples of medical devices within FGB include:

  • Interactive Walkway
  • Electrical stimulation device for prevention of pressure ulcers in wheelchair users

Frameworks for clinical investigation

This CCMO page (in Dutch and in English) helps you determine which framework to apply to your clinical research with a medical device. This is necessary because each framework has specific requirements for the review process, including:

The MDR review process for FGB researchers

The submission procedures described here will primarily refer to the CCMO or to NedMec+, an METC representing the Antoni van Leeuwenhoek, Prinses Maxima Centrum and UMC Utrect hospitals, and which the Amsterdam UMC joined on July 1 2026. The guidance should be transferable to other METCs because all METCs are guided by the CCMO, but keep in mind that procedures could differ slightly outside of the NedMec+ context.

All submissions will go through the Research Portal(Onderzoeksportaal) regardless of the committee reviewing your submission. If your MDR research is for the purposes of obtaining or expanding the CE certification of the medical device, your standard research file will be reviewed first by the CCMO (still within the Research Portal) to confirm that your application is complete and valid (more information in Dutch and in English).

The templates used in all standard submissions are written with multiple use-cases in mind, so if you find yourself unsure how to fill in certain sections of a template, check the FGB specifics section.

➣Review the submission requirements

  • Standard submission requirements
    • The coding described for each document should be automatically added when each document is uploaded in the the Research Portal(Onderzoeksportaal) and the portal should ask you to provide a version date and number for each document.
  • Primary review (Dutch guidance / English guidance)
    • You must submit a standard research file on your primary submission. The documents required for a standard research file are listed here in Dutch and here in English)
    • The content of the MDR standard research file depends on the framework your MDR research falls within. You also need to know which framework applies so that you can adjust any template documentation according to the applicable framework.
    • There are some specific language requirements for the standard research file:

➣FGB specifics

  • B1 ABR form (Dutch guidance / English guidance)
    • Under section 1.5, if you are unsure how to fill in the billing information, you can contact your department manager for assistance
    • Section 8.10 of the ABR form is about insurance. See “Insurance for WMO research within FGB” for more information on how insurance is organized for WMO research within the VU.
      • If your MDR research is only subject to the MDR but not the WMO, make a request for exemption from insurance.
    • Section 11.3 is about publishing research data. If your aim is to publish de-identified participant data, make sure to follow FGB and VU requirements to ensure this is done safely, legally and ethically. You can assess the level of risk posed by the data you plan to share with this risk app. Based on the risk level, you can review the recommended procedures for reuse of data after the current research project. You can also contact the FGB Privacy Officer for guidance on how to approach this topic. NB: it is possible to determine your data sharing plan after your research is reviewed by the METC, but make sure you have a plan in place before you begin data collection because consent is very often one of the most important aspects that will allow future data reuse.
  • C1 Research protocol
  • E1 Subject Information Sheet and informed consent form (Dutch guidance / English guidance)
    • Section 6 of the information letter template is about insurance. See “Insurance for MDR research within FGB” for more information.
    • Appendix A contact information:
    • In addition to Section 5 and Appendix C of the template, it is a VU requirement to have a privacy statement that participants can refer to at their leisure. See this page for more information on privacy statements. You can submit the privacy statement in section E4 Other informational materials of the standard research file.
      • It is recommended to include a reference to the privacy statement in the information letter. Include the following text: “In de bijgevoegde privacyverklaring vindt u meer informatie over hoe wij uw persoonsgegevens gebruiken in dit onderzoek” at the end of section 5 of the model information letter. It is also advised to include a motivation in your standard research file to inform the METC of this minor addition and the reason for its inclusion. You can use the following standard text for this: “Conform het beleid van de Vrije Universiteit Amsterdam dient elk onderzoek te worden voorzien van een privacyverklaring als aanvulling op de informatiebrief. Deze is ingediend onder categorie E4 (‘Overig voorlichtingsmateriaal’). Tevens is daartoe een verwijzende zin in de informatiebrief opgenomen.”
  • G Insurances (Dutch guidance / English guidance)
  • I2 Site Suitability Declaration (VGO) / Research declaration (Dutch guidance / English guidance)
    • Most FGB research uses the research declaration (onderzoeksverklaring) for this part of the standard research file; a full VGO is only necessary when research with medical products is being carried out
  • K3 Clinical Trial Agreements(Dutch guidance / English guidance)
    • Since FGB research usually requires a research declaration (onderzoeksverklaring) to declare the suitability of the research site, if you require a clinical trial agreement you must use the template (only in English) that is suited to studies with a research declaration. If your MDR research is not subject to the WMO, you can alternatively use this template (only in English).

Things you should be aware of

➣Insurance for MDR research within FGB

If your MDR research is also subject to the WMO, follow the guidance on the page “Insurance for WMO research within FGB” for more information on how insurance is organized for WMO research within the VU.

If the WMO does not apply to your MDR research and you only need to provide proof of VU liability insurance, contact for a copy of the necessary documentation.

NB: VU liability insurance covers research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

➣Costs of MDR research and budgeting

MDR research involves many extra costs that need to be estimated and accounted for in your budgeting, especially if you are obtaining funding from a grant provider. You are expected to cover these costs with your project budget, therefore it’s important to estimate what these costs will be during your grant application. The primary costs that you need to take into account are:

  • The costs of a MDR review by an METC/CCMO
    • For FGB researchers (i.e. external applicants) funded by research grants (i.e. not by industry), the cost of review depends on the framework your MDR research falls within. Costs can range from €2670 to €4000. Review of substantial amendments can range from €221 to €850 and the review of an Investigational Medical Device Dossier (IMDD) costs €885 per device submitted.
    • The costs of review can differ across METCs.
  • The costs of participants’ insurance
    • If your MDR research is subject to the WMO and also requires participants’ insurance, there will be additional costs per participant included in the study. For 2026, this cost is €45 per participant.

Other medical research regulations

There are other regulations that can also apply to medical-scientific research. For example:

Support

If you have questions or need additional support, contact the FGB REPS team. REPS has also created a peer-to-peer Teams channel for researchers conducting WMO research; the channel provides a place where researchers can help each other out in finding answers and solutions to questions or issues that arise around their WMO review process (and the REPS team is in the channel too to help of course!). Questions about the MDR and other medical research regulations are very likely to come up in this channel, so even if the WMO doesn’t apply to your research, if you have to deal with these other regulations you are welcome to join for support.

If you would like to join this Teams channel, contact .