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)


Contact us

Please contact Tukija in advance for possible extra documentation requirements (in addition to the afore-mentioned ones)