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
- To access the medical device information system, you need individual access authorization, which consists of a user code and password.
- New notification, registration: This is for initial, change and revocation notifications for address details, medical devices and IVD as well as for initial and change applications and notifications for clinical trial / performance evaluation test.
- Every new advertisement and every change notification receives an automatically generated form number. For research in the database, your advertisement can be found more quickly using the form number.
- After entering the data and the system-based plausibility check, you can either just save the respective display or forward it to the responsible authority. In addition, existing initial reports for IVD and initial applications can be used as a template for creating new advertisements / applications.
- The data is transferred to the “In process” component. If the notification is forwarded, the responsible authority is automatically informed by email and can only then view and edit the data.
Process for Non-EU Manufacturer
- Designation of European Authorised Representative
- Provide your European Authorised Representative with relevant documentation
- Document review
- Registration on the DIMDI
- Name and code of the medical device, its classification, its nomenclature, name of the Manufacturer or its authorised representative or importer
- CE Conformity Certificates
- EC Declaration of Conformity (must be in German)
- Packaging box (Box, Labelling and instructions for use (must be in German))
- Technical file
What We Offer
- Act as your AR
- Register your medical devices in the Germany Database
- Keep you up to date with the Germany regulatory requirement
Why Choose Us
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
Contact us for free consultation: [email protected]