Medizinproduktgesetz

The Medizinproduktgesetz, often abbreviated as MPG, was a German federal law that regulated the placing on the market, commissioning, and use of medical devices. It was enacted in 1995 and served as the national implementation of European Union directives concerning medical devices. The primary aim of the MPG was to ensure the safety and performance of medical devices available to patients and healthcare professionals. It covered a broad spectrum of products, from simple bandages and syringes to complex imaging equipment and implantable devices.

The law established a framework for conformity assessment procedures, which medical device manufacturers had to follow to demonstrate that their products met essential requirements for safety and performance before they could be placed on the market. This typically involved a risk-based approach, with higher risk devices undergoing more rigorous assessment. The MPG also laid down obligations for manufacturers, importers, distributors, and users of medical devices, including requirements for labeling, instructions for use, and post-market surveillance.

In 2021, the Medizinproduktgesetz was repealed and replaced by the Medizinproduktegesetz (MPG) which implemented the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Medical Device Regulation (IVDR). This transition aimed to further harmonize regulations across the EU and enhance the safety and traceability of medical devices. While the original MPG is no longer in effect, its historical significance lies in establishing a comprehensive legal basis for medical device regulation in Germany during a crucial period of European integration in this field.