Performance studies of IVD-devices

The table below presents the situations in which the sponsor of a performance study shall enter and submit an application following articles 58 or 70 to the Finnish national authority Fimea if the study is to be conducted in Finland. In addition to IVDR, also Finnish Act on Medical Devices (719/2021) Chapter 3 Clinical investigations and performance studies of in vitro diagnostic devices needs to be followed as applicable if the performance study is conducted in Finland.

Prior to the deployment of the Eudamed database, the applications and notifications shall be submitted to Fimea using Fimea’s Secure Mail Service (https://secmail.fimea.fi/) to [email protected] (further information about secure mail submissions). 

• Application form (pdf)
• Required application documents (pdf)
• Other forms: MDCG 2022-19 (pdf)

Please note that the performance study synopsis should be submitted in Finnish or in Swedish (719/2021, 15 § (Finlex, in Finnish and Swedish))

If a sponsor intends to introduce modifications to a performance study that is conducted according to article 58 (1,2) or article 70 and the modifications are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, the sponsor shall notify the changes to Fimea within one week. All updated documents should be submitted as appendices with clear marking of the changes made.

Fimea should also be notified if changes are introduced to studies notified to Fimea before 26th of May 2022.

The notifications are done via email [email protected]. 

Serious adverse events (death, serious deterioration in the health of the subject,  life-threatening illness or injury) and device deficiencies in performance studies conducted according to IVD regulation are reported to Fimea. Detailed instructions for reporting can be found from the guidance document MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. Reporting should be done using the tabular format attached to the guidance (link below).

Performance Study Summary Safety Reporting Form (xlsm)

Within performance studies started before 26th May 2022, reporting of SAE and device deficiencies shall be carried out in accordance with the IVDR requirements from 26 May 2022.

The end of a performance study coincides with the last visit of the last subject unless another point in time for such end is set out in the performance study plan. For performance studies conducted under Article 58 (1,2) or Article 70, a notification of the end of that performance study shall be made to Fimea within 15 days of the end of the study.
If the performance study has been temporarily halted or terminated early, Fimea shall be notified within 15 days. If the temporary halt or early termination has been performed on safety grounds, Fimea shall be informed within 24 hours.

A performance study report shall be submitted to Fimea irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt of the study. The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. 

Notifications related to termination or halt of the performance study and performace study reports shall be submitted via email [email protected].

The processing fees pertaining to performance evaluation studies are based on the Decree on fees chargeable by the Finnish Medicines Agency (pdf).