Medizinprodukte; Beantragung eines Freiverkaufszertifikats

Some third countries require proof that the medical device in question is marketable in the European Economic Area (EEA) before it can be placed on the market in their country. The certificate of marketability issued by the competent authority (certificate of free sale) serves as this proof.

Competent authorities

The Bavarian State Office for Health and Food Safety (LGL) is responsible for active medical devices.

The following governments are responsible for non-active medical devices:

• Government of Upper Franconia: responsible for the administrative districts of Upper Palatinate, Upper Franconia, Middle Franconia and Lower Franconia
• Government of Upper Bavaria: responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia.

• Proof of the marketability of the medical devices to be exported (declarations of conformity, certificates from a notified body)

  If there are several products, it makes sense to enclose a summary in the form of a text or table file.

The requirements are set out in Section 10 of the Medical Devices Law Implementation Act (MPDG).

At the request of the manufacturer or its authorized representative, the competent authority shall issue a certificate of free sale in accordance with Article 60(1) of Regulation (EU) 2017/745 or Article 55(1) of Regulation (EU) 2017/746 (IVDR). A certificate of free sale may also be issued for devices placed on the market in accordance with Article 120(3) of Regulation (EU) 2017/745 or Article 110(3) of Regulation (EU) 2017/746. This applies accordingly to devices that were lawfully placed on the market before May 26, 2021 in accordance with the national provisions transposing Directives 90/385/EEC and 93/42/EEC and may continue to be made available on the market or put into service until May 26, 2025.

The fee is set out in the schedule of costs, tariff no. 7.I.9/6. The costs (fee and expenses) are to be borne by the applicant.

The certificate of free sale must be applied for from the competent authority:

• for active medical devices: to the Bavarian State Office for Health and Food Safety
• for non-active medical devices: depending on the manufacturer's place of business, to the Government of Upper Franconia or the Government of Upper Bavaria

The application can be submitted online using the online procedure provided.