Medizinprodukte - Bescheinigung über die Verkehrsfähigkeit

If you want to place medical devices on the market for the first time, you can apply for a certificate of marketability of the medical device(s) for export.

Manufacturers or authorized representatives placing medical devices on the market for the first time may apply for a certificate of marketability of the medical device(s) for export.

The manufacturer's current declaration(s) of conformity for the medical devices and the certificate from the Notified Body (except for Class I devices), if these have not already been submitted.

The manufacturer or authorized representative must be based in Thuringia and the medical devices to be exported must be indicated in the DIMDI Information System Medical Devices.

Fees are charged in accordance with the Thuringian Administrative Cost Regulations for the Ministry of Labor, Social Affairs, Health, Women and Family Affairs (TMASGFF); Part E; No. 2.1.4.

The amount of the fees (80.00 to 500.00 Euro) is differentiated between a first-time issuance and the issuance of a further marketability certificate as well as the number of contained products.

The application can be submitted informally by e-mail or by mail.

In addition to the applicant's contact details, the application should contain the following information:

• the exact designations of all medical devices to be exported (if applicable, with article numbers and/or other additions required for identification)
• the indication of the country of destination (if this is to be indicated)
• the language accepted in the country of destination (recipient country) (English, Spanish or French)
• if applicable, the number of similar certificates of marketability to be issued (in case of certificates without indication of a country of destination)

• Medical devices - certificate of marketability
• Manufacturers or authorized representatives who place medical devices on the market for the first time can apply for a certificate of marketability of the medical device(s) for export.
• The application can be made informally by email or by mail.
• Fees will apply.
• Responsible: Thuringian State Office for Consumer Protection (TLV); Department 21 - Technical Consumer Protection, Market Surveillance.

Contact the Thuringian State Office for Consumer Protection (TLV); Department 21 - Technical Consumer Protection, Market Surveillance.

informal application