Responsible for the service Finnish Medicines Agency Fimea
Notification of interruption or discontinuation of the supply of a medical device
- Permit or other obligation
- Nationwide
- Public service
Article 10a of amending Regulation (EU) 2024/1860 obliges the manufacturer to give notice where it is reasonably foreseeable that the interruption or discontinuation could cause serious harm or risk of serious harm to patients or public health in one or more Member States.
Manufacturer notifies:
- the competent authority of the Member State in which the manufacturer or its authorised representa ...
Do the following
The manufacturer reports the information to the competent authority using the form MDCG 2024-16. The information is submitted to Fimea by email: laiteinfo@fimea.fi or registry@fimea.fi.
Deadline
Outside exceptional circumstances, the information shall be provided at least six months before the interruption or discontinuation of the supply.
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Finnish Medicines Agency FimeaResponsible for the service
Finnish Medicines Agency FimeaText edited by: Finnish Medicines Agency Fimea
Updated: 2/1/2026