German laws and regulations

German laws and regulations impose specific requirements that go beyond those of the EU regulations. The requirements affect manufacturers, operators, and users of medical devices.

1. Interaction with EU regulation

a) Past: Implementation of EU directives

In the past, German laws and regulations were tasked with transposing EU medical device directives into national law. Specifically, these were:

• Medical Device Directive (MDD)
• In Vitro Diagnostics Directive (IVDD) (German)
• Active Implantable Medical Devices Directive (AIMDD)

The Medical Device Regulation (MDR) adopted the general requirements specified in the directives by direct reference and supplemented the requirements with national particular requirements such as the medical device consultant.

The national medical device law also determines the level of penalties (fines and imprisonment) for non-compliance.

National ordinances supplemented these laws.

b) Present: Supplementing the EU regulations

The EU regulations (MDR and IVDR) are already binding laws that are valid without first being transposed into national laws and regulations. However, the EU regulations give national states the option of using national laws to specify and (within a narrow framework) supplement the requirements of the regulations.

For example, national laws determine the respective responsible authorities. For example, the Medical Devices Implementation Act (MPDG) in Germany determines the BfArM as this authority.

In addition, the MPDG supplements the MDR requirements (e.g., the requirement for a medical device consultant) and continues to determine the penalties for violations.

2. Overview of German laws and regulations

a) With direct reference to medical devices

The German law is the aforementioned Medical Devices Implementation Act (MPDG), which was passed by parliament. It is supplemented by the national ordinances published by the Federal Ministry of Health, e.g.:

• Medical Device Operator Ordinance (MPBetreibV)
• Medical Device User Notification and Information Ordinance (MPAMIV), which has replaced the Medical Device Safety Plan Ordinance (MPSV)
• Ordinances on fees

b) With indirect reference to medical devices

Other German laws and regulations affect medical devices, at least indirectly:

• Digital Care Act (DVG)
• Law on Digital Modernisation of Healthcare and Nursing Care (DVPMG)
• Digital Health Applications Ordinance (DiGAV)

These laws amend existing laws, such as the 5th Social Security Code.