Opinions on devices under special procedure for notified bodies
View connections →Notified body must seek Fimea’s opinion if EMA opinion is not required.
Published by: Fimea · Government organisation
Description language: English
Coverage: All Finland
About this service
Description
If a device incorporates, as an integral part of its operation, an ancillary medicinal substance or companion diagnostics, the notified body must, as part of the conformity assessment process, request the opinion of a competent pharmaceutical regulatory authority on the device. The notified body can request an opinion from Fimea in cases where an opinion should not be requested from EMA. The opinion is mandatory and must be considered as part of the certification decision made by the notified body.
How to use it
Medical devices incorporating a medicinal substance Dossier: - A cover letter, EMA’ application form (pages 6–17 completed), information about the medical device, a declaration signed by a qualified expert and CV, report of the notified body on the benefits of adding the medicinal substance component, and device labels. - Quality and clinical summary - The appropriate quality documentation, CEP/ASMF/PMF - The appropriate preclinical documentation - The appropriate clinical documentation Companion diagnostics Dossier - Application form (without page 5) - Draft instructions for use (IFU) - Draft safety and performance summary
Fee details
The fee for statements is based on the current Decree on fees chargeable by the Finnish Medicines Agency
Where and how to get help
Requesting an opinion, devices with a special additional procedure · Online service
As part of the conformity assessment process, the notified body must request an opinion from the competent pharmaceutical authority.
Description: English · Service languages: Swedish, English, Finnish
Check the official service page for current hours, exceptions, identification requirements and further contact details.