Digitalisation in the medical technology sector is progressing steadily. This is accompanied by the connection of medical devices of all kinds with a wide variety of non-medical devices. Typical examples of this are patient monitoring or the digital operating theatre.
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MD Comp
The challenge
Medical devices fulfil a medical purpose and are subject to strict regulations, such as the European Medical Device Regulation (MDR) and the applicable standards, while non-medical devices are subject to different and often much less stringent requirements. The major challenge for manufacturers and operators is now to integrate medical devices with non-medical devices in systems with a medical purpose, while demonstrably guaranteeing safety and performance. This is difficult if the necessary information is not available or not available in a suitable form for the non-medical devices to be integrated, which is regularly the case.
The solution: MD Comp
With "MD Comp", the VDE has developed a new concept that addresses this problem. MD Comp offers a structured approach to qualifying the technical properties of non-medical devices so that they can be integrated into medical systems in a compliant manner. The goal of efficient integration is achieved by applying relevant requirements for medical devices to non-medical devices in order to qualify them as compliant with medical devices.
Compliance-by-design
A central component of MD Comp is the "compliance-by-design" approach. This means that selected regulatory requirements are already taken into account in the early development phases of a product. For example, by identifying the relevant requirements from the medical technology sector and incorporating them into the design. This ensures that non-medical devices fulfil specific requirements for medical devices, enabling seamless integration and safe operation as part of medical technology systems.
Advantages of MD Comp
In addition to compliance and safety in system integration, the MD Comp approach also offers improved market acceptance for these products. Due to compliance with selected safety requirements, MD Comp products will be favoured for medical applications. Another advantage is that MD Comp products are explicitly not to be understood as accessory in the sense of the MDR, as their purpose is not medical-specific. This avoids potential inconsistencies in the demarcation.
Application and future prospects
Manufacturers and operators should consider the MD Comp approach as early as possible in the development process. To explain the implementation, the authors have applied the MD Comp approach to selected chapters of the medical device safety standard IEC 60601-1. It is recommended to apply the approach to other medical technology safety standards and also to integrate it into standardisation work at national and international level. It is also proposed to link MD Comp to the European legal framework, for example by developing a corresponding MDCG guideline. In addition, the definition of accessories should be clarified so that a differentiation from MD Comp products that do not fall under the framework of European medical device regulation is possible.
Conclusion
MD Comp is an innovative and practical solution for the safe and compliant integration of medical devices and non-medical devices. By incorporating regulatory requirements at an early stage and adopting a structured approach, efficient and secure networking in the healthcare sector can be achieved.
The VDE DGBMT recommendation "MD Comp - A practical framework to integrate non-medical devices and medical devices in a compliant way" was developed as part of the "Connected Health" initiative of the 6G Platform Germany and the BMBF-funded 6G Health research project under the coordination of the VDE DGBMT Regulatory Affairs Technical Committee.
