Finnish government authorities provide a reliable environment for research and development, with clear approval processes. Neurocenter Finland provides guidance and assistance to navigate approvals, contracts and related issues in research and development.
Scientific research aimed at a commercial product requires careful planning. The Finnish law for medical research (488/1999) is applicable to most medical research, including pharmaceutical and medical device research. The law specifies that the research investigation must be approved by the ethical committee before the study can commence. In addition, the study should be designed and implemented in accordance with the principles of Good Clinical Practice (GCP).
The Finnish Medicines Agency Fimea monitors and regulates all clinical trials in Finland. Fimea must be notified before any intervention study is initiated. Usually, the research sponsor makes this notification; however, if there is no external research sponsor, the researcher needs to notify Fimea.
The National Supervisory Authority for Welfare and Health Valvira must be notified of any clinical trial involving human subjects: Valvira defines, evaluates and verifies the purpose and characteristics of the medical device or accessory intended for human use. Notifications are required for clinical trials conducted for devices without the CE marking. Notifications are also required if the study deviates from the original intended use or instructions for use specified by the device manufacturer. Notifications are always required for research involving active implantable medical devices.
Finnish Testbed / Living lab services provide an authentic testing and research environment for health technology solutions from a company, including university hospital departments, polyclinics and municipal primary health care centers. Services may include cooperative development for innovations, testing for products and solutions, collaborative research, and clinical studies for medical devices.
Publications: Nordic infrastructure of test facilities