Can a network isolator be a medical device?

What is a medical device

A medical device is an object or substance which is used for therapeutic or diagnostic purposes for humans, whereby the main intended effect, unlike that of medicinal products, is not primarily pharmacological, metabolic or immunological, but usually physical or physicochemical.

The network isolator as a medical device

In medical technology, network isolators can be used as accessories or components of a medical-electrical device or system. However, a single network isolator is not a medical device within the meaning of the Medical Device Directive 93/42/EEC as it does not fulfil any therapeutic or diagnostic purpose. However, the Medical Devices Act allows the operator of an active medical device to manufacture a medical-electrical system himself in accordance with § 12 MPG, the so-called in-house production. This means that a network insulator in combination with a medical electrical device becomes a medical-electrical system and is therefore subject to the Medical Device Directive 93/42/EEC. In this case, the "own manufacturer" must check whether all medical devices are operated and used in the area of intended use.









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