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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