Procedure descriptions

Apply for certificates of free sale for medical devices

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.

Forms/Online Services

Freiverkaufszertifikate für Medizinprodukte beantragen

Responsible authority

The four regional councils in Baden-Württemberg (Freiburg, Karlsruhe, Stuttgart and Tübingen) are responsible. Local jurisdiction depends on the administrative district in which the manufacturer's or authorised representative's head office is located. For example, the Freiburg regional council is responsible for manufacturers based in Tuttlingen (Freiburg administrative district).

Regierungspräsidium Freiburg

Hausanschrift

Bissierstraße 7

79114 Freiburg i. Br.

To the electronic timetable information

Contact

Telefon (07 61) 2 08-0

Fax (07 61) 2 08-39 42 00

E-Mail poststelle@rpf.bwl.de

Servicekonto Sichere Servicekonto-Nachricht über service-bw.de senden

Details

Prerequisite

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

Procedure

You submit your application
The competent authority checks the documents
The competent authority requests additional documents if necessary
The competent authority issues the certificate

Deadlines

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.

Required documents

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

Costs

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.