1. The European Medical Device Regulation (EU) 2017/745 (MDR)


The definitions provided below by the relevant legislation give a description of the types of technologies in question.

The European Medical Device Regulation (EU) 2017/745 (MDR) 

The MDR governs the design, clinical investigations, production, distribution and commercialisation of Medical Devices in Europe. It brings a range of strengthened requirements that collectively raise the bar for Medical Devices placed on the EU market and aims thereby to increase the safety for the patient.

Article 2 (1) of the MDR [2] defines a ‘Medical Device as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.
  • Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.
  • Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and 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.
  • The following products shall also be deemed to be Medical Devices:
    • Devices for the control or support of conception.
    • Products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

The Regulation also applies to the groups of products without an intended medical purpose that are listed in Annex XVI (e.g., Contact lenses, equipment intended to be used to reduce, remove or destroy adipose tissue, etc.).