Authorisation studies

A pivotal study in the context of the Medical Device Regulation (MDR) for Europe and the Medical Device Law Implementation Act (MPDG) for the implementation and supplementation of the MDR in Germany is

a clinical investigation conducted to assess the safety and performance of a medical device before it can be placed on the market.

These studies are crucial in order to fulfil regulatory requirements and obtain approval for a product on the European market.

Regulation through MDR and MPDG

• MDR: The European Medical Device Regulation (MDR) sets out strict requirements for clinical investigations to ensure the safety and effectiveness of medical devices. It requires a comprehensive evaluation through clinical studies before a product is authorised.
• MPDG: The Medical Devices Implementation Act (MPDG) supplements the MDR in Germany and regulates specific national requirements, such as the notification and authorisation of clinical investigations by the competent higher federal authorities, e.g. the Federal Institute for Drugs and Medical Devices (BfArM).

German) Social Code Book V (SGB V)

The German) Social Code Book V (SGB V) regulates statutory health insurance in Germany and has an indirect impact on the approval of medical devices by influencing reimbursement and the inclusion of medical devices in the health insurance companies' catalogue of benefits.

Overall, pivotal studies are a critical part of the process of bringing new medical devices to market, as they form the basis for evaluating the safety and effectiveness of the devices and ensuring that they comply with legal requirements.

Can we support you too? You are welcome to arrange a first non-binding appointment here.