Medical technology – medical equipment – active medical devices

Medical technology is a subset of medical devices, also known as medical equipment. At the same time, medical technology forms an organizational unit in hospitals.

1. Overview of medical technology / medical equipment

a) Terms and taxonomy

The term medical device is the umbrella term for many product categories. For example, a distinction is made between:

• Active and non-active medical devices: Active medical devices have a power supply, usually in the form of a mains connection or a battery or rechargeable battery.

• Sterile and non-sterile medical devices: The Medical Device Regulation (MDR) places particular requirements on devices that must be sterile. For example, a conformity assessment is not permitted without the involvement of a notified body.

• Medical devices with and without a measuring function: Manufacturers must also involve a notified body in the conformity assessment of devices with a measuring function.

Medical equipment is usually considered “physical” Programmable Electrical Medical Systems (PEMS), i.e., active medical devices. Standalone software is not classified as medical equipment.

Fig. 1: In the taxonomy of medical devices, medical equipment corresponds to physical active medical devices, particularly Programmable Electrical Medical Systems (PEMS).

The term medical technology is sometimes used synonymously with the term medical equipment. Occasionally, it refers to the department in the hospital that is responsible for these medical devices.

There are often problems with the classification of clinical information systems. These are often medical devices but do not count as classic medical technology.

b) Importance of medical technology

Medical technology is an essential economic factor. BVMed, for example, provides the latest figures.

An article highlights the trends in medical technology. These include the development and use of autonomous systems and closed-loop systems.

2. Regulatory requirements for medical equipment

a) Requirements for manufacturers

As medical equipment is a subset of medical devices, all regulatory requirements for medical devices also apply to medical equipment.

In addition to the General Safety and Performance Requirements (GSPR), manufacturers should fulfill the requirements for medical electrical equipment and the IEC 60601 family. In addition to the requirements for electrical safety, these also include requirements for interoperability, essential performance, and functional safety.

b) Requirements for operators

Operators of medical devices and medical technology are also subject to legal requirements.

The keyword article on hospitals, laboratories, and other operators contains an overview. It refers to the requirements for installing, maintaining, and decommissioning medical devices. It also addresses specific product types, e.g., combinations of medical devices, devices combined by multiple socket-outlets, and medical device PCs.