The National Supervisory Authority for Welfare and Health
Valvira should be notified at the beginning of the clinical investigation by using the form available in Valviras's websites “Notification of a clinical investigation of medical devices”.
The processing fees charged for a clinical investigation notification are:
335 € for products in category A (non-risk products)
840 € for products in category B (risk products)
There is a 60-day waiting period for Class III devices and implantable, long-term invasive devices in Classes IIA or IIB. Clinical investigation can be initiated at the end of a 60-day period after notification, unless Valvira has requested further information or notified within that period of a decision to the contrary based on safety considerations. No notification is required if the medical device for clinical investigation is CE-marked and the purpose of use is the same as the manufacturer has defined. When the investigation has been completed, the sponsor should compile a report available to the Valvira as soon as possible but within one year of completion at the latest. Valvira should also be informed of essential changes in the Clinical Investigation Protocol. If the investigation is terminated prematurely Valvira should be informed promptly and provided with the reason for the termination.