Freiverkaufszertifikate für Medizinprodukte beantragen

Artikel 60 (EU) 2017/745 (MDR)

Artikel 55 (EU) 2017/746 (IVDR)

Medizinprodukterecht-Durchführungsgesetz (MPDG):

• § 10 Freiverkaufszertifikate

Are you responsible for placing a medical device on the market in accordance with Article 5 of Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices and would like to export this to non-EU third countries ? Then the relevant competent authority can issue a certificate in accordance with Section 10 MPDG at your request.

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

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

• Product must be placed on the market in accordance with Article 5 and Article 10 or 11 of Regulation (EU) 2017/745 of a medical device
• Product must be placed on the market in accordance with Article 5 and Article 10 or 11 of Regulation (EU) 2017/746 of an in vitro diagnostic medical device
• Only manufacturers and authorised representatives based in Germany can submit an application for a certificate of free sale for medical devices and in vitro diagnostic medical devices here

Cost type: variable

Description of costs: Fee

Note: Medical device law is federal law and is enforced by the respective federal states. Therefore, the respective fee ordinance 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: up to 3 weeks

The certificate of marketability according to § 10 MPDG confirms the status as of the date of issue. Each recipient country decides on the period of validity of the certificate itself.

The online service is still under construction, please contact the responsible regional council.

• Appeal under the LVwVfG against the rejection of an application and the charging of fees