Differences between medical technology and medical devices

Medical technology and medical devices are often used synonymously, as they have several things in common, overlap in parts and are central components in the healthcare system:

• Medical intended purpose: Both are intended for use in humans to diagnose or treat disease.
• Regulatory requirements: Both medical devices and medical technology appliances are subject to strict legal requirements to ensure safety and effectiveness for patients and users.
• Driven by innovation: Both divisions are strongly innovation-driven and invest significantly in research and development to provide new and improved healthcare solutions.
• Diverse users: They cover a wide range of applications, from simple aids such as spectacles and wheelchairs to complex appliances such as pacemakers and computer or magnetic resonance imaging
• Mode of action: The main effect of both is not pharmacological (like medication) or by influencing the metabolism or immune defence, but physical or a mixture of physical and chemical elements.

Colloquially, medical technology and medical devices are often used interchangeably, as they have several things in common, including intended purpose, strict regulatory requirements, innovation orientation, diverse users and a primarily physical mode of action.

Terminology around medical technology and medical devices

Medical technology is an interdisciplinary engineering specialisation that develops and manufactures principles and technologies for the development and manufacture of products, appliances and procedures for the prevention, diagnosis, treatment and monitoring of diseases.

Medical devices are to be distinguished from medical technology as a subgroup of medical devices.

Medical devices are products with an intended medical purpose that are intended by the manufacturer of these products for the treatment or examination of humans.

Assistive products are objects or technical products that are necessary to ensure the success of medical treatment, to prevent an impending disability or to compensate for a disability. They must not be general articles of daily use and must fulfil legally defined quality requirements.

Legal (regulatory) framework:

• EU Medical Device Regulation (MDR) 2017/745: This regulation sets out strict requirements for the safety, performance and clinical evaluation of medical devices in the European Union.
• In Vitro Diagnostic Medical Devices Regulation (IVDR): This Regulation (EU) 2017/746 regulates the safety and performance requirements for in vitro diagnostic medical devices (IVD) in the European Union and sets similar requirements to the MDR.
• Medical Devices Implementation Act (MPDG): This national law supplements the MDR and regulates its implementation in Germany.
• Medical Device Operator Ordinance (MPBetreibV): This regulates the operation and use of medical devices in health institutions, including requirements for inventories, testing and maintenance of appliances and reporting obligations.
• ISO 13485:2016 specifies requirements for a quality management system for the manufacturer and design of medical devices and is closely related to DIN EN ISO 9001, but focusses more on the safety of medical devices.
• EN ISO 14971 deals with the risk management of medical devices and is crucial for identifying and managing risks throughout a product's life cycle.
• ISO 27001 is relevant for the development of medical devices and medical technology as it sets requirements for an information security management system (ISMS) to ensure the confidentiality, integrity and availability of data.
• IEC 60601-1 specifies the general requirements for the safety and essential performance of medical electrical appliances.
• IEC 82304-1 relates to healthcare software that is hardware-independent and describes comprehensive requirements for design, development, validation, installation, maintenance and disposal.
• IEC 62366 specifies requirements for the usability of medical software to ensure that it can be used safely and effectively.
• ISO 14155 regulates the requirements for the planning, conduct, documentation and reporting of clinical investigations involving medical devices to ensure the safety and well-being of the subjects and the integrity of the data.
• Research and development: Additional regulations may apply depending on the specific research area, e.g. guidelines for clinical studies or ethics committees.

Medical technology is subject to the same regulatory requirements as medical devices, but with a broader focus on research, development and manufacturing processes.

Liability risks

There are considerable liability risks for both medical devices and medical technology. Hospital managers, for example, are responsible for the proper maintenance of medical devices.

To summarise, the term medical devices refers to the specific appliances and instruments used in medical practice, while medical technology encompasses the scientific and technical aspects that contribute to the development, manufacture and improvement of these products. Both areas are subject to strict regulatory requirements designed to ensure the safety and effectiveness of the products as well as the quality of the manufacturing processes, but they have different focuses and requirements.

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