Medical Devices

Medical devices are materials, objects or software that are used for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases, but whose main intended effect is not achieved by pharmacological, immunological or metabolic means.

Medical devices include, for example, wound plasters, hearing aids, contact lenses, scalpels, dialysis catheters, pacemakers, stents, prostheses, artificial joints, wheelchairs, hospital beds or medical technology (e.g. CT devices). 

In-vitro diagnostics are a special group of medical devices that are used to examine sample material (e.g. blood, urine or saliva) outside the human body (i.e. “in-vitro”).

Substance-based medical devices consist of substances or combinations of substances and are often similar to medicinal products in terms of presentation and dosage form; however, they develop their main intended effect via physicochemical and/or physical modes of action (whereas medicinal products have pharmacological, immunological or metabolic effects). Substance-based medical devices can include, for example, saline nasal drops or sprays, antibacterial mouth rinses or products for heartburn.

Before medical devices can be placed on the market in the EU, they must undergo a conformity assessment procedure and submit a declaration of conformity for the product (which confirms that the product meets the legal requirements, particularly with regard to safety and technical or clinical performance) in order to receive a CE mark.

Throughout the life of the medical device, data on its quality, performance and safety must be collected and analysed and the necessary preventive or corrective measures must be taken as part of vigilance.