Registration of medical devices in Germany follows European Union (EU) regulations and the technical International Standard for Organization(ISO). Medical devices regulated by the Federal Institute for Drugs and Medical Devices (bfArM) are used for physical (not medicinal) purposes. Examples of these include implants, bandaging supplies, and dental devices.
The five classes of medical devices (MDs) are regulated by the bfArM.
Class I – custom made medical device kits; e.g., stethoscopes, bandaging supplies, contact lenses, and dental devices. Technical specifications and conformity test results are required by the bfArM before European Conformity (CE) certification.
Class IIa – Devices implanted in the body for one hour up to 30 days; e.g., hearing aids.
Class IIb – Devices kept in body 30+ days.
Class III – Active implants (AIMDs); e.g., pacemakers.
GMDN – Global Medical Device – a generic ID of an uncategorized medical device.
Manufacturers of these devices must obtain the European Conformity (CE) marking for their products to legally sell in the EU market. Average processing time for a German manufacturer to obtain the CE is 4-6 weeks.
Manufacturers from outside the EU must appoint an European Authorized Representative(EAR). This person is responsible for the initial marketing of the MD must notify the local authority responsible for the relevant Federal State.
Along with initial marketing, the responsible person must identify the person responsible for safety and inform a competent authority. These notifications are made online through the German Institute for Medical Documentation and Information(DIMDI) website.
Manufacturers should not use any 3rd party distributors to market their products. Distributors are increasing rapidly, especially in small towns, and they are eager for your business. You will lose some basic control, and if you no longer do business with the distributor, re-registration will be required.
Germany is one of the countries in the EU that requires additional information to obtain the CE marking. BfArM used the electronic portal DIMDI. Manufacturers have to complete the following tasks:
1- If the manufacturer, importer, or Authorized Representative(AR)of the product is registered as a business in Germany, they must notify BfArM before the DIMDI device is placed on the market.
2 – Assign a Safety Officer and notify of the assignment on the same DIMDI system.
3 – All labeling and Instructions for use must be in German.
4 – Adverse event reporting should be made to the respective institutes depending on the type of MD.
Manufacturers are also required to prepare a statement of the technical specifications, quality assurance audit, and design approval. This statement or letter goes through the European Notified Body (ENB) to the Regulatory Authority(RA) before product is sent to market.
Germany has the largest medical device market in Europe ($26 billion) and the third largest in the world. The United Kingdom(UK) and France are the two main competitors in Europe’s medical device market. It is dominated by small and medium-sized businesses(SMEs).
Germany is interested in new technology, diagnostic MDs, and non-invasive or minimally invasive devices to support their outstanding medical care. Products of interest include new diagnostic and therapeutic devices and non-invasive or minimally invasive MDs.