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)


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


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