Apply for over-the-counter certificates for active in vitro diagnostics
Are you responsible for placing an in-vitro diagnostic device on the market and would like to export it outside the European Union? Then the respective competent authority will issue a certificate according to §10 MPDG upon your request.
As a manufacturer of in vitro diagnostics or its authorized representative, you can apply for the issuance of a certificate of free sale for export purposes. The certificate of free sale confirms that the manufacturer or authorized representative has its registered office in Germany and that the product in question can be traded within the Union.
- Product must be placed on the market according to Article 5 Article 10 of Regulation (EU) 2017/746 of an in vitro diagnostic medical device.
- Only manufacturers and authorized representatives based in Germany can apply here for a certificate of free sale for in vitro diagnostic medical devices