What are medical devices?

In addition to ventilators or defibrillators, which are traditionally thought of as medical devices, medical devices also include several devices found at home, for example blood pressure monitor, sticking plasters, glasses, hearing aid or condoms. Medical devices also include, for example, eye drops intended for moistening the eyes or cold gel used for muscle pain. Pregnancy and laboratory tests are so-called in vitro diagnostic (IVD) medical devices.

Hygiene products (e.g. sanitary napkins), well-being meters (e.g. heart rate monitors), personal protective equipment (e.g. respirators) or hand disinfectants are not medical devices.

The manufacturer of the product is responsible for whether the device is classified as a medical device. It is therefore important to note that no product group alone defines a product as a medical device, but the intended purpose and the mechanism of action defined by the manufacturer are key factors when assessing whether the product is a medical device or some other product, for example a medicine or a cosmetic product.