MD German Law

German law & regulations

Here you will find some relevant documents required for manufacturing and distribution of medical devices in Germany.

The Experience Exchange Group of members from the Notified Bodies certified under the German medical device law (in German: Erfahrungsaustauschkreis der nach dem Medizinproduktegesetz benannten Stellen, short: EK-Med) provides several guiding documents from Definition papers to Regulations & Standards to Declarations of Conformity you may have to abide by when putting your medical device on the German market.

Also, you can find legal texts introducing you briefly to the German law and regulations. Please note all documents are in German.