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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.
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:
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 certificate of free sale must be applied for from the competent authority:
The application can be submitted online using the online procedure provided.
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.