Finland Fimea

Medical device instructions for use must be accessible and understandable to the user

Learning from medical device incidents is possible when they are reported

Guidance on the importance of reporting medical device incidents to enable learning and safety improvements.

Application of the AI Act transparency obligation in medical devices

Guidance on how the AI Act's transparency requirements apply to artificial intelligence used in medical devices.

Fimea updates pharmacy online service regulation – call for comments on changes needed

Fimea invites stakeholder input on amendments to regulations governing pharmacy online services.

Fimea continues to provide CTIS guidance to clinical trial researchers on an as-needed basis

Fimea will continue to offer targeted guidance to clinical trial researchers on CTIS (Clinical Trials Information System) use as needs arise.

Finnish translation of Good Clinical Practice (GCP) guidance published

Fimea has published a Finnish-language translation of Good Clinical Practice guidance.

New version of XML-format basic register available