Apply for certificates of free sale 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 Union? Then the 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 issue of a certificate of free sale for export purposes. The certificate of free sale confirms that the manufacturer or authorized representative has its registered place of business in Germany and that the product in question can be traded within the Union.

Regional Council Kassel

Please contact the Regierungspräsidium Kassel.

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

Forms available: No
Written form required: No
Informal application possible: Yes
Personal appearance necessary: No

• Product must be placed on the market in accordance with 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 submit an application for a certificate of free sale for in vitro diagnostic medical devices here

Appeal under the VwVfG against the rejection of an application and the charging of fees

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

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 on the period of validity of the certificate itself.