Authority for Justice and Consumer Protection

Apply for free sale certificates for medical devices

As a manufacturer of medical devices and in-vitro diagnostics or its authorized representative, you can apply for the issuance of a free sale certificate for export purposes.

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Application for the issuance of a free sale certificate for medical devices

Detailed description

Are you responsible for placing a medical device on the market according to Article 5 and Article 10 of Regulation (EU) 2017/745 or Article 5 and Article 10 of Regulation (EU) 2017/746 of an in-vitro diagnostic device and would like to export it outside the Union? Then the competent authority will issue a certificate according to § 10 MPDG upon your application. This certificate certifies that the product can be traded in the Union.

 

Information

Prerequisites

  • The product must be placed on the market according to Article 5 and Article 10 of Regulation (EU) 2017/745 for a medical device or Article 5 and Article 10 of Regulation (EU) 2017/746 for an in-vitro diagnostic device
  • Only manufacturers and authorized representatives based in Hamburg can apply for a free sale certificate for medical devices or in-vitro diagnostics here

Documents required

  • Declaration of Conformity(s)
  • Certificate(s) from the notified body(s)
  • product list

Please note

No

Deadlines

The certificate of marketability according to § 10 MPDG does not contain any limitations. It confirms the status as of the date of issue. Each recipient country decides for itself how long the certificate is valid.

Procedure

  1. You submit your application
  2. The competent authority checks the documents
  3. The competent authority may request additional documents
  4. The competent authority issues the certificate

Processing time

1 to 3 weeks

Fees

Medical product law is federal law and is enforced under the sovereignty of the respective federal states. Therefore, the respective cost or fee schedule of the federal state must be applied. In the Free and Hanseatic City of Hamburg, this is the schedule of fees for public consumer protection.

Legal remedies

Objection according to VwVfG against rejection of an application or the charging of fees

Legal basis

Links on the Internet

Address and contact information

Authority for Justice and Consumer Protection

Office for Consumer Protection
Pharmaceuticals, Medical Devices, Chemicals Law and Product Safety

An das Postfach 30 28 22 kann nur Post gesendet werden. Pakete senden Sie bitte stattdessen an die Drehbahn 36, 20354 Hamburg.

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Last updated: 10.10.2026