Freiverkaufszertifikate für nicht-aktive Medizinprodukte beantragen

As a manufacturer of non-active medical devices or its authorized representative, you can apply for the issue of a certificate of free sale for export purposes outside the EU and countries that have a free trade agreement with the EU

Are you responsible for placing a non-active medical device on the market and wish to export it outside the Union? Then the relevant competent authority will issue a certificate at your request.

This certificate certifies that the product may be traded in the Union.

• Declaration of conformity of the medical device concerned
• Certificate(s) of the Notified Body(ies) of the medical device concerned
• Certification of the manufacturer's quality management by a notified body
• Product list in accordance with the MDR

• Your establishment is located in the area of responsibility of the relevant authority and you are registered in Eudamed.
• Your medical devices concerned are registered in DMIDS.
• There are no known concerns on the part of the authority.
• Current documentation of the medical devices concerned is available.
• It is a non-active medical device.

1. You submit your application.
2. The competent authority checks the documents.
3. The competent authority requests additional documents if necessary.
4. If all requirements are met, the competent authority issues the certificate of free sale

There are no deadlines for the application.

Objection according to Administrative Procedure Act (VwvVfG) against the charging of fees

• Certificates of free sale for the export of medical devices Issued for medical devices excluding in-vitro diagnostics - non-active
• Certificates of free sale are issued for non-active medical devices.
• A certificate of free sale can be applied for by manufacturers or EU authorized representatives.
• To apply for a certificate of free sale, the medical devices must meet the legal requirements and be supported by a declaration of conformity.
• Medical devices that have been notified and CE-marked are marketable within the EU and the associated contracting states, i.e. there is no need to issue a certificate.
• The issuing of a certificate of free sale is subject to a fee.
• Responsible: State Office for Social Affairs, Youth and Care (LSJV) - Department 5 - Division 54 - Medical Devices

Please contact the Landesamt für Soziales, Jugend und Versorgung (LSJV) - Abteilung 5 - Referat 54 - Medizinprodukte.

Forms available: No

Written form required: Yes

Informal application possible: Yes

Personal appearance necessary: No

Online services available: Yes