Some third countries require proof that the medical device in question is marketable in the European Economic Area (EEA) before it can be placed on the market in their country. The certificate of marketability issued by the competent authority (certificate of free sale) serves as this proof.
Competent authorities
The Bavarian State Office for Health and Food Safety (LGL) is responsible for active medical devices.
The following governments are responsible for non-active medical devices:
- Government of Upper Franconia: responsible for the administrative districts of Upper Palatinate, Upper Franconia, Middle Franconia and Lower Franconia
- Government of Upper Bavaria: responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia.