Freiverkaufszertifikate für Exportzwecke von Medizinprodukten Ausstellung Für In-Vitro-Diagnostika- nicht aktiv
Inhalt
Freiverkaufszertifikate für Exportzwecke von Medizinprodukten Ausstellung Für In-Vitro-Diagnostika- nicht aktiv
Begriffe im Kontext
nicht vorhanden
Fachlich freigegeben am
31.01.2025
Fachlich freigegeben durch
nicht vorhanden
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 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 European Union.
- You submit the required documents to the competent authority by post or electronically.
- The competent authority checks the documents.
- The competent authority requests additional documents if necessary.
- The competent authority issues the certificate.
The certificate of marketability according to § 10 MPDG does not contain any
time limits. It confirms the status as of the date of issue.
Each recipient country decides for itself on the duration of the certificate's validity.