Combined Clinical Trials on Medicinal Product and Device

In this context, a combination study means a clinical trial on medicinal product in accordance with the Clinical Triasl Regulation (536/2014), which combines a medical device study in accordance with the MD Regulation (2017/745) or an in vitro diagnostic device study in accordance with the IVD Regulation (2017/746).

Please note the following:

  • The medical device related documentation should be submitted simultaneously with the clinical trial on medicinal product
  • Documents with identical content should not be submitted twice

Documents to be submitted:

  • Signed cover letter (incl. EU CT number and a list of attachments)
  • Investigator’s Brochure (IB) concerning the medical device
  • Protocol for medical device (if separate)
  • Protocol summary for medical device (if separate)
  • Information sheet and informed consent form and possible other material given to the research subject (if separate) 

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Application for ethics review of clinical trial on medicinal device (combined clinical trial on medicinal product and device)


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