MDR and MPBetreibV

The Medical Device Regulation (MDR) and the German Medical Devices Operator Ordinance (MPBetreibV) provide essential regulatory foundations for medical devices. While the MDR defines the European framework for safety, performance and regulatory compliance throughout the entire lifecycle, the MPBetreibV governs the safe operation and use of medical devices in Germany.

MDR (Medical Device Regulation)

The European MDR (Medical Device Regulation) plays a central role in operators' obligations, as it defines the overarching legal framework for the safety, performance and regulatory compliance of medical devices throughout their entire lifecycle.

The Medical Device Regulation (MDR) has provided the regulatory framework for medical devices within the European Union since 2021. The regulation aims to improve patient safety and ensure consistent market surveillance across Europe. The MDR places extensive requirements on manufacturers regarding risk management, clinical evaluation, technical documentation, traceability (UDI), post-market surveillance and vigilance. Compliance with harmonised standards such as ISO 13485, ISO 14971 or IEC 60601 helps demonstrate conformity with the MDR's general safety and performance requirements.

The Role of the MDR for Operators

• Ensuring patient safety: The MDR establishes the fundamental requirements for protecting patients and users from risks. For operators, this means that they may only use products that meet these stringent European requirements.
• Part of the regulatory framework: Alongside national legislation such as the MPBetreibV, the MDR is the key European regulation with which operators, including hospitals and clinics, must ensure and demonstrate compliance.
• Focus on the entire lifecycle: The MDR requires devices to be monitored even after they have been placed on the market (post-market surveillance). Operators play an important role by carrying out regular testing and maintenance to help preserve the device's performance characteristics in everyday clinical use.
• Risk management: The regulation emphasises the importance of continuous risk management. Operators support this by identifying and preventing potential hazards at an early stage through testing in accordance with applicable standards, such as IEC 62353.
• Relationship to the MPBetreibV: While the MDR establishes the general European requirements for medical devices, the MPBetreibV specifies the actions operators in Germany must take, such as carrying out safety inspections (STK) and metrological inspections (MTK), to ensure compliance during ongoing operation.

German Medical Devices Operator Ordinance (MPBetreibV)

The German Medical Devices Operator Ordinance (MPBetreibV) governs the safe operation and use of medical devices in Germany. It is primarily aimed at operators of hospitals, medical practices and care facilities.

Among other things, the ordinance requires:

• proper commissioning of medical devices,
• training users in the operation of the devices,
• regular safety inspections (STK),
• metrological inspections (MTK), where required,
• servicing and maintenance in accordance with the manufacturer's instructions,
• documentation of all tests and maintenance activities, and
• reporting of serious incidents.