Before the launch of the Eudamed database, applications and notifications are submitted to Fimea using the application form which can be found in MDCG 2021-08:

• Application form

If several devices are used in a clinical investigation, provide device information by copying pages in Section 3 and 4 as attachments and notifying information separately for each additional device.

Notifications and applications concerning clinical investigations are sent electronically through Fimea’s secure mail service (https://secmail.fimea.fi/) to: [email protected] (information about sending secure mail). 

NOTE: The maximum size of a message with attachments sent using the Secure Mail service is 50 MB. If the message size exceeds 50 MB, the secure mail service will notify of a transmission failure. In such a case, the material to be sent can be divided into several different messages that are clearly indicated as being interrelated. The maximum size of a message with attachments sent using other mailboxes is 10 MB.

The signed form complete with attachments may also be sent by post to Fimea. 

Clinical investigation supporting documents

The required supporting documents for investigations under Article 62 or 74(1) of the MDR are listed in document “Clinical investigation supporting documents - Appendix of documents to attach” (Annex 5 in MDCG 2021-08). Please submit the document along with the application to support the traceability of the documents.

The required supporting documents for investigations under Article 82 of the MDR are listed in Fimea’s Administrative Regulation 1/2022 Clinical investigations conducted with medical devices.  

Opinion of the Ethics Committee

An opinion of the Ethics Committee is always required before submitting an application or notification and initiating an investigation. The opinion (and possible opinions concerning previous processing) must be attached to the application and submitted to Fimea.

Clinical investigation plan 

A clinical investigation plan must be prepared in line with Section 3 of Chapter II of Annex XV. Guidance document MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices may help with preparing the Clinical investigation plan. You can also use Annex A to ISO 14155:2020. You can submit the clinical investigation plan in English, but the summary must be in Finnish or in Swedish (719/2021, Section 15).

Investigator’s brochure

If a sponsor of an investigation is the device manufacturer, an investigator’s brochure (IB) is required to be attached to the application. The investigator’s brochure must contain all clinical and non-clinical information on the investigational device that is relevant for the investigation. The investigator's brochure should be prepared in line with Section 2 of Chapter II of Annex XV to the MDR. Guidance document MDCG 2024-5 Guidance on the Investigator’s Brochure content may help in preparing the document. Annex B to ISO 14155:2020 may also be helpful.

Applications for an investigation are processed at Fimea according to the schedules defined for the regulatory pathway chosen.

• Fimea processes applications for clinical investigations that fall under Article 62 of the MDR in accordance with the deadlines specified in Article 70. The processing of an application includes a so-called validation phase. The last day of that phase is the validation date on which Fimea notifies the applicant on whether the clinical investigation falls within the scope of the Regulation and whether the application is complete. The next step is a more detailed assessment of the content of the application for an investigation.
• Investigations that fall under Article 82 of the MDR are processed according to the deadlines set out in national law. Fimea processes the applications in accordance with Article 71 of the MDR, with respect to the deadlines set out in Article 70 and Section 21 of the National Act on Medical Devices 719/2021. 
• If the investigation falls under Article 74(1) of the MDR, Fimea must be notified at least 30 days prior to commencement of the study. 

Further clarification may be requested from the sponsor during all phases of the processing.

The sponsor may start the clinical investigation in the following circumstances: 

• For class I devices, immediately after the validation date of the application provided that a negative opinion has not been issued by an ethics committee;  
• For other device classes, as soon as the body responsible for processing/assessment has notified the sponsor of its authorisation, and provided that a negative opinion has not been issued by an ethics committee. 

An investigation that falls under Article 74(1) may be initiated at the earliest 30 days after submitting a notification of the investigation.

Notifications and reports concerning changes to clinical investigations, termination or suspension of a clinical investigation and adverse events are sent by email to: [email protected]. 

Substantial modifications to clinical investigations

If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, the sponsor must notify Fimea of the change within one week.

You can submit the notification using the document “Substantial modification of clinical investigation under Medical Device Regulation” attached to MDCG 2021-28. Include an updated version of the relevant documentation where the changes are clearly identifiable. Please send the notification by email to: [email protected]. 

MDCG 2021-28

Reporting of adverse events that occur during clinical investigations

Any serious adverse events that occur during a clinical investigation concerning the investigational device, the comparator or the investigation procedure must be reported to Fimea in accordance with MDCG 2020-10/1 “Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745”, using the form MDCG 2020-10/2. 

The same guidance applies to the reporting of adverse events concerning investigations initiated under Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC.

Termination, temporary halt or early termination of investigations

The end of a clinical investigation is deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the clinical investigation plan. A notification of the end of the clinical investigation must be made within 15 days of the end of the clinical investigation. If an investigation is temporarily halted or terminated early, a notification must be made within 15 days of the end of the clinical investigation, providing a justification. If an investigation is suspended or terminated early on safety grounds, the notification must be made within 24 hours, providing a justification.

Irrespective of the outcome of the clinical investigation, an investigation report must be submitted within one year of the end of the clinical investigation or within three months of the early termination or temporary halt. The investigation report must be accompanied by a summary presented in terms that are easily understandable to the intended user.

Processing fees for clinical investigations are based on the current Decree on fees chargeable by the Finnish Medicines Agency. You can find more information about fees (in Finnish) on the page “Lääkinnällisten laitteiden maksut” (Fees for medical devices).