Combined Clinical Trials on Medicinal Product and Device

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

The Ethics Committee opinion is required before the device application can be submitted for regulatory evaluation to Fimea’s medical device section.

Initial application for a device study combined with a clinical trial

• The medical device–related documentation should be submitted to Tukija using the form below simultaneously with the clinical trial application on medicinal product submitted in the CTIS system.
• Documents with identical content should not be submitted twice (both in CTIS and device application).

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)
• Materials provided to the study participants related to the device (e.g. a separate information sheet and consent form, if these have not been submitted with the CTIS application).

Substantial modification

• A substantial modification application must be submitted if the modification has a substantial impact on the safety, health, or rights of the study participants, or on the reliability or robustness of the clinical data generated in the study.
• Documents must be submitted both as clean version and as tracked-changes version.
• The application must be submitted simultaneously with a CTIS application if it is connected to such application.

Request for information and opinion

• The request for information with reply instructions will be sent to the email address provided by the applicant.
• The Ethics Committee opinion will be sent to the email address provided by the applicant.

Processing times

• The Ethics Committee meets once a week throughout the year.
• The application will be reviewed at the committee meeting approximately in 2–3 weeks after its submission.
• If the application is combined with a clinical trial application in the CTIS system, both applications will be processed according to the timelines set out in the EU Clinical Trials Regulation (536/2014). Please note that the request for information process also follows CTIS timelines.

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Application form for clinical device study