Federal Institute for Drugs and Medical Devices (BfArM) - Germany

The Federal Institute for Drugs and Medical Devices (BfArM) is the central higher federal authority in Germany responsible for the safety and quality of medical devices. Its primary mission is to assess risks and protect patients through effective market surveillance and regulatory oversight.

1. Regulatory Framework

The regulation of medical devices in Germany is governed by:

• EU Medical Device Regulation (MDR) 2017/745: The overarching European framework.
• EU In Vitro Diagnostic Regulation (IVDR) 2017/746: For diagnostic devices.
• MPDG (Medizinprodukterecht-Durchführungsgesetz): The German Medical Device Law Implementation Act.

2. Key Roles and Tasks

The BfArM performs several critical functions to ensure device safety:

Risk Assessment and Vigilance

BfArM collects and evaluates reports of incidents and recalls. If a device poses a risk, the institute can issue recommendations or monitor Field Corrective Actions (FCAs) taken by manufacturers.

Classification and Differentiation

BfArM decides on the regulatory status of a product (e.g., whether it is a medical device or a medicinal product) and determines its risk class.

Clinical Investigations

The institute is responsible for the authorization and monitoring of clinical investigations and performance studies for medical devices and IVDs.

Digital Health Applications (DiGA)

Unique to Germany, BfArM assesses Digital Health Applications (DiGA) for their positive healthcare effect. Approved apps are listed in the DiGA directory and can be prescribed by doctors for reimbursement.

Information System (DMIDS)

BfArM operates the German Medical Devices Information and Database System (DMIDS), which is used for the electronic notification and registration of medical devices and clinical investigations.