Freiverkaufszertifikate für nicht-aktive In-vitro Diagnostika beantragen

• Medical Devices Implementation Act (MPDG)
• Article 55 In-vitro Diagnostics Regulation (IVDR) - Regulation (EU) 2017/746
• Regulation (EU) 2017/746 Article 11 for EU authorized representatives

Are you responsible for placing an in-vitro diagnostic product on the market and would like to export it outside the Union? Then the relevant competent authority will issue a certificate upon your request.

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 would like 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.

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

• 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

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.

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

Duration: 1 to 3

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.

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

• Certificates of free sale for export purposes for medical devices Exhibition For in vitro diagnostics - not active
• Certificates of free sale are issued exclusively for medical devices and in vitro diagnostics.
• A certificate of free sale can only be applied for by the manufacturer or the European authorized representative based in the Federal Republic of Germany.
• The medical devices and in vitro diagnostic medical devices applied for must meet the legal requirements and be CE-marked.
• CE-marked medical devices and in-vitro diagnostics can be marketed within the EU and the associated contracting states without official confirmation. This means that no certificate of free sale is issued.
• Fee-based service

Please contact the Regierungspräsidium Kassel.

Regional Council Kassel

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