Freiverkaufszertifikate für aktive In-vitro Diagnostika beantragen

As a manufacturer of in vitro diagnostic medical devices that are associated with an active medical device, or its authorized representative, you can apply for the issue of a certificate of free sale for export purposes.

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

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

• Declaration of conformity of the medical device concerned
• Certificate(s) from 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 IVDR

• 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.

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 under the Administrative Procedure Act (VwvVfG) against the charging of fees

• Certificates of free sale for export purposes of medical devices Exhibition For in vitro diagnostics - active
• Certificates of free sale are issued for in vitro diagnostic 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 in vitro diagnostic medical devices must meet the legal requirements and be supported by a declaration of conformity.
• Notified and CE-marked in vitro diagnostic medical devices 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 the Environment (LfU) - Department 2 - Division 25.1

Please contact the State Office for the Environment (LfU) - Department 2 - Division 25.1.

Forms available: No

Written form required: Yes

Informal application possible: Yes

Personal appearance necessary: No

Online services available: Yes