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 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.
Outside exceptional circumstances, the information shall be provided at least six months before the interruption or discontinuation of the supply.