Scope under the Medical Device Regulation

Scope under the Medical Device Regulation

Devices falling under the Medical Device Regulation (MDR) are 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, but which may be  assisted in its function by such means.

The following products shall also be considered as medical devices:

  • devices for the control or support of conception;
  • products specifically intended for the cleaning, disinfection or sterilization of devices

Some aesthetic devices are now falling under the scope of the Medical Device Regulation (MDR).

Accessories of medical devices shall be considered as medical devices.

Devices with both a medical and a non-medical intended purpose shall fulfill cumulatively the requirements.

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