Clinical investigations - legal requirements for authorisation

A clinical investigation in the context of the Medical Device Regulation (EU 2017/745, MDR) for Europe and the national law, for Germany the Medical Device Law Implementation Act (MPDG) for the implementation and supplementation of the MDR  is

a clinical investigation conducted to evaluate the safety and performance of a medical device before it is placed on the market.

These clinical investigations (clinical trials for medical devices) are crucial in order to fulfil regulatory requirements and obtain approval for a medical device on the European market.

Regulation through MDR and - in Germany - the MPDG

• MDR: The MDR sets out strict requirements for clinical investigations inEurope to ensure the safety and effectiveness of medical devices. It requires a comprehensive evaluation through clinical investiations before a product is authorised.
• MPDG: The Medical Devices Law 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 German 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, clinical investigations 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.

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