Medical Device Advisory Clinic
- Service
- Nationwide
- Public service
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 sh ...
Do the following
Requests for Medical Device Advisory Clinic and other inquiries should be sent by e-mail to: cie@fimea.fi.
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.
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 cie@fimea.fi.