Germany Medical Device Regulations

Medical Device Registration in Germany: Navigating CE Mark and BfArM Requirements

Updated on 26/01/24
Overview:As a member of the European Union, Germany adheres to the device classification system outlined in the EU Medical Device Directives (MDD), set to be succeeded by the EU Medical Device Regulations (MDR). The classification in Germany spans four risk-based classes: I, IIa, IIb, and III, with Class I representing the lowest risk and Class III the highest.

The process of registering medical devices in Germany, as in the entire European Union, necessitates obtaining the CE Mark. This widely recognized symbol signifies compliance with current EU standards and regulations. The CE mark not only permits free marketing within all EU member states, including Germany, but also streamlines the regulatory process by eliminating the need for separate submissions in 28 different countries. This unified approach, facilitated by the CE mark, allows companies to market and sell their products simultaneously across all EU member states, providing a time- and cost-saving mechanism.

While the CE mark serves as a comprehensive indicator of compliance, it’s noteworthy that certain EU member countries, including Germany, may impose additional requirements beyond the mark before a product can be marketed or sold. In addition to CE marking, manufacturers must establish a Quality Management System (QMS). The ISO 13485 certification is widely accepted as a suitable QMS and is valid for three years.

Germany, among other EU countries, introduces specific additional requirements for medical device registration. The Federal Institute for Drugs and Medical Devices (BfArM) in Germany operates an electronic portal known as DIMDI, providing a streamlined platform for manufacturers to navigate these additional requirements. DIMDI plays a crucial role in enhancing transparency and efficiency in the regulatory process, making it an essential component for manufacturers seeking to register medical devices in Germany.

Regulatory Authority: Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)
The Federal Institute for Drugs and Medical Devices (BfArM) is a federal authority within the Federal Ministry of Health that involves employees in licensing, improving the safety of medicinal products, detecting and evaluating risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors.
The main aim is to increase the safety of medicinal products and patients, contributing to public health prevention. The BfArM also provides high-quality information for all health system areas via the internet.

Its main tasks include authorizing finished medicinal products based on the Medicinal Products Act, reviewing health benefits, efficacy, safety, and pharmaceutical quality.
The BfArM also handles European drug licensing, with homoeopathic drugs either registered without indications or licensed with indications.

Link for Regulatory Authority: https://www.bfarm.de/EN/Home/home_node.html

Local Regulation:

https://www.bfarm.de/EN/Medical-devices/Overview/Laws-and-ordinances/_node.html

Classification:

Class I, IIa, IIb and III

Listing or Registration Requirements:

All medical devices must bear the CE marking in order to be marketed.Class I can be marketed immediately upon the completion of the technical documentation.
Non-EU Manufacturers must appoint an Authorized European Representative.
The individual responsible for the first marketing of a medical device with a registered office in Germany must inform the local authority in the relevant Federated State.
Furthermore, upon initial marketing, the responsible person must identify the person responsible for the safety and inform the Competent Authority.
Notifications must be made online through BfArM website.

Documents Required for Registration:

Name and code of the medical device, its classification, its nomenclature, name of the manufacturer or its authorized representative or importer
CE Conformity Certificates
EC Declaration of Conformity
Packaging box (Box, Labelling and instructions for use)
Technical file