Medical Device Advisory Clinic

Medical Device Advisory Clinic

Under its Medical Device Advisory Clinic, Fimea provides, in response to a written request and based on a case-by-case consideration, an opportunity for an informal discussion during the planning stage of a clinical investigation for clients who do not yet have sufficient knowledge of the regulatory requirements concerning clinical investigations conducted with medical devices. 

The discussion should focus on planned clinical investigations that are to be carried out in Finland and the regulatory requirements pertaining to them. Fimea does not issue precedents. The advice given will not be binding on Fimea or the party requesting advice. The Medical Device Advisory Clinic is free of charge. 

The meetings are primarily arranged via Teams. The duration of the meeting is 30 to 60 minutes, depending on the scope of the consultation. 

Seeking Medical Device Advisory Clinic and inquiries 

Requests for Medical Device Advisory Clinic and other inquiries should be sent by e-mail to: [email protected].

Include the following information and clarifications to your free-form request for advice: 

  • contact person(s) 
  • details of the advice sought from other authorities and details of any clinical investigations conducted in Finland 
  • brief summary of the topic or potential problem to be discussed 
  • brief description of the investigational device and its intended purpose 
  • other sufficient background information related to the topic, e.g., a description of the design, target population, and goals and hypotheses of the investigation
  • proposed meeting date and time and participants. 

Secure mail instructions for confidential material. 

Fimea will inform the applicant of the acceptance or rejection of the request by e-mail. If the request is accepted, Fimea will propose a meeting date. The client is requested to prepare a memorandum of the consultation meeting within two weeks, on which Fimea will provide its comments within two weeks if needed. 

The scope and availability of Medical Device Advisory Clinic activities are affected by Fimea’s other statutory duties. In urgent matters, it is recommended to contact Fimea freely at the e-mail address [email protected]