We only need 2 pieces of information from you.
Specify your location to receive regionalized information.
You searched in services/administrative services.
Apply for certificates of free sale for active in-vitro diagnostics
Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)
Are you responsible for placing an in vitro diagnostic medical device on the market in accordance with Article 5 and Article 10 of Regulation (EU) 2017/746 and wish to export it outside the Union? Then the relevant competent authority will issue a certificate in accordance with Section 10 MPDG at your request.
This certificate certifies that the product may be traded in the Union.
- You submit your application
- The competent authority checks the documents
- The competent authority requests additional documents if necessary
- The competent authority issues the certificate
Who should I contact?
State Office for Social Services of the State of Schleswig-Holstein
- 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
Which documents are required?
- Declaration of conformity
- Certificate(s) of the Notified Body(ies)
- Product list
What are the fees?
Cost type: variable
Description of costs: Fee
Note: Medical device law is federal law and enforcement is the responsibility of the respective federal states. Therefore, the respective cost or fee regulations of the federal state must be applied.
What deadlines do I have to pay attention to?
Note (for further information on the time limit): 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.
Duration: 1 week to 3 weeks
In Schleswig-Holstein, processing times of up to 6 weeks may occur in exceptional cases.
Appeal under the VwVfG against the rejection of an application and the charging of fees
What else should I know?
In Schleswig-Holstein, no distinction is made between active and non-active medical devices as well as active and non-active in vitro diagnostic medical devices.
The text was automatically translated based on the German content.
Technically approved by
Hessian Ministry for Social Affairs and Integration (HMSI)
Professionally released on