Freiverkaufszertifikate für Exportzwecke von Medizinprodukten Ausstellung Für Medizinprodukte exkl. In-Vitro-Diagnostika - aktiv

Are you responsible for placing a medical device on the market and would like to export it outside the Union? Then the respective competent authority will issue a certificate according to §10 MPDG upon your request.

As a manufacturer of medical devices 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.

• Declaration of Conformity
• Certificate(s) from the Notified Body(ies)
• Product list

• Product must be placed on the market according to Article 5 and Article 10 of Regulation (EU) 2017/745 of a medical device.
• Only manufacturers and authorized representatives based in Germany can apply here for a certificate of free sale for medical devices.

1. You submit your application.
2. The competent authority checks the documents.
3. The competent authority requests additional documents if necessary.
4. The competent authority issues the certificate.