Product standards and certifications

Products bearing the Medical Device CE marking must meet all the essential and applicable requirements laid down in Annex I of EU Regulation 2017/745 (former Directive 93/42/EEC) on medical devices. The Directive defines a “medical device” as any instrument, apparatus, implant, software, substance or other product, used alone or in combination, including accessories like software intended by the manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for the correct functioning of the device itself, intended by the manufacturer to be used on humans for:

• diagnosis, prevention, control, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation or compensation of an injury or disability;
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
• control of conception which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

MDs are divided into four classes, according to the characteristics and the degree of risks associated with them, as laid down in Annex IX of Directive 93/42. The classes, starting from the lowest risk class, are divided into:

• Class I MD – low-risk devices. Devices that fall into this class do not require the intervention of a notified body (apart from sterile devices and/or devices with a measuring function), and must be registered with the competent local authorities.
• Class IIa and llb MD – medium-risk devices for which the intervention of a notified body is required.
• Class III MD – high-risk devices for which the intervention of a Notified Body is required.