Medical Technology

Medical Technology

Saving Lives Around the Globe

Microfluidics Robot Dispenses Green Fluid| © iStockphoto

Source: Microfluidics Robot Dispenses Green Fluid| © iStockphoto

Market Access

Foreign exporters must be aware that, in order to place medical devices on the market for the first time, the products must be registered with the appropriate competent authorities. In general, the manufacturer or authorized representative is responsible for the introduction of new medical devices on the market. The medical device's importer is responsible in cases where the manufacturer's location is outside the European Union and an authorized representative in the EU has not been designated. The Federal Institute for Drugs and Medical Devices (BfArM) offers detailed information on the EU directives on medical devices as well as guidance in accessing the German medical device market and the prerequisites to be fulfilled. Furthermore, a list of notified bodies can be found on the German Institute of Medical Documentation and Information's website (DIMDI). This site offers access to about 60 databases with approximately 100 million documents.

Manufacturers and importers of medical products must also make sure that their products comply with the REACH regulations (Registration, Evaluation and Authorization of Chemicals). According to REACH, companies are required to prepare information on the chemical substances used in their products and register the data with the European Chemicals Agency (ECHA). Registration is required for most hazardous substances above 1 ton per year, for substances toxic to the aquatic environment above 100 tons per year, or substances manufactured or imported above 1.000 tons per year. For many medical products compliance with REACH is a prerequisite for affixing the CE marking.

All medical devices intended for the German market must bear a CE marking before they can be sold or installed. The CE marking is a mandatory conformity mark attached to certain products intended for sale within the European Union which indicates conformity with the essential health and safety requirements set out in the applicable European directives. Depending on the type of product, conformity can be assessed either by the manufacturer himself or by an authorized office.

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