Combined Clinical Trials on Medicinal Product and Device
In the case of combined clinical trials processed in CTIS in accordance with the Regulation (536/2014), the form below should be employed for submitting the documentation concerning solely to the medical device/devices.
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If you want to submit a new medical device part to an already accepted clinical trial on medicinal product under the Directive (2001/20/EC), this should be submitted as a Substantial Amendment. Before submitting an application, the classification of the study should be consulted from Fimea.
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)