What was the German Medical Devices Act?

The German Medical Devices Act, or Medizinproduktegesetz (MPG), formed a central part of Germany's medical-device framework for many years. It addressed matters including placing devices on the market, clinical investigations and supervision. Today, the term is particularly relevant when interpreting older documentation and transitional situations.

The MPG should not be treated as the sole applicable basis for a current project. European regulations and Germany's Medical Device Law Implementation Act (MPDG) have largely replaced it. The rules for a particular product depend on its type and any applicable transitional status.

Which rules apply today?

Medical devices are principally governed by Regulation (EU) 2017/745, the Medical Device Regulation (MDR). In-vitro diagnostic devices have a separate framework, Regulation (EU) 2017/746 (IVDR). The MPDG supplements these European rules in Germany, including responsibilities and procedures.

The BfArM overview of legislation helps identify the relevant instruments. Certain legacy products have transitional arrangements with specific conditions. A product's age or an existing certificate alone does not establish continued eligibility for marketing.

How do medical devices reach the market?

Devices generally undergo conformity assessment and bear CE marking when the requirements are met. This differs from a medicine's marketing authorization. Depending on risk class and product characteristics, a Notified Body must participate; the same assessment route does not apply to every device.

Classification particularly depends on intended purpose and the applicable classification rules. Clinical evaluation, technical documentation and post-market surveillance have related requirements. CE marking is not a general quality endorsement issued by an authority.

What does this mean for pharmaceutical and device marketing?

Claims must fit the actual intended purpose and available evidence. An older MPG certificate should not be presented as evidence of current MDR status without checking. CE marking also does not justify broad claims of superior performance or efficacy.

Software, diagnostics and medicine-device combinations benefit from early regulatory classification. Website copy, packaging and sales materials can contribute to the stated intended purpose. Editorial and regulatory teams therefore need a consistent understanding of the product's current status.

Conclusion: Interpret the historical term accurately

The MPG remains relevant to legal and product history. Current decisions need to consider the MDR or IVDR, the MPDG and any applicable transitional provisions together. Naming the correct framework avoids misleading statements about product status and market access.