Medical Device Registration In Germany
Regulatory Authority of Germany
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), BfArM, is the institution responsible for regulating medical devices in Germany. Headquartered in Bonn, BfArM operates under the Federal Ministry of Health.
All medical devices marketed in the EU must bear the CE mark to certify conformity with EU law.
Germany is one of the EU countries that require additional requirements outside of the CE mark. BfArM has an electronic portal called DIMDI.
There are unique prerequisites concerning the first place on the market in Germany. The first placing on the need of a medical device by a responsible person who has his registered place of business in Germany must be notified to the local authority of the concerned federal state.
The person responsible for placing first on the device’s market is the manufacturer or their authorised representative. If the manufacturer does not have his/her registered place of business in the European Economic Area and if an authorised representative has not been designated, or if medical devices are not being imported into the European Economic Area under the responsibility of the authorised representative, the importer shall be the person responsible. The name of the firm and the address of the person responsible must appear on the label or in the instructions for the use of the medical devices.
In addition, responsible persons with their registered place of business in the FRG must immediately after the beginning of the activity determine a safety officer who is sufficiently reliable and possesses the necessary expert knowledge. The safety officer has to be notified to the competent authority of the respective Federal State.
If the manufacturer is headquartered outside the European Union, the requirements under the Portuguese regulation must be completed by a legal representative in the Community or, European Authorized Representative (AR).
A single AR may only represent the manufacturer for each type of device. Thus, to enter the medical devices market, manufacturers of medical devices are required to appoint an AR, which will assist with all the details regarding the registration process and assist in completing requirements under the German regulation.
The online registration can be done on the medical device information system DIMDI: https://www.dimdi.de/dynamic/de/medizinprodukte/
Timeline for registration: 1 month-9 months
The Federal Institute for Drugs and Medical Devices (BfArM) and some units of the German Institute for Medical Documentation and Information (DIMDI) were merged into BfArM on 26 May 2020. After the transition period, all registrations will take place on BfArM.
Registration Process for DIMDI
Process for Non-EU Manufacturer
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