The monitoring of the manufacture, placing on the market and circulation of medical devices (including their operation and use) and the related implementation of the Medical Devices Act and its ordinances is the exclusive responsibility of the state authorities in Germany (§ 26 MPG). We would therefore ask you to contact the state authority responsible for you. This would be the state authority where your company or distributor is located.

Under the following link you can find out the competent state authority yourself: Medical Devices → Institutions.

If you have a CE mark for your medical product that is valid for the European market, you can also market the product in Germany. You can find an overview of the relevant EU directives for CE marking under the following link:
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html

The BfArM does not issue export certificates. According to § 34 (1) MPG the competent authority issues a certificate of marketability of the medical device in Germany upon application of a manufacturer or authorised representative for export. We therefore ask you to contact your competent supervisory authority with your request.

Unfortunately, this is not possible for us, as standards are subject to copyright protection and may not be reproduced. An overview of standards and procurement options can be found at Beuth-Verlag (www.beuth.de).

Questions on the eligibility for reimbursement of medical devices are not within the scope of responsibility of the BfArM. We therefore ask you to contact the Kassenärztliche Vereinigung in your federal state.