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.
- The Regulation: MDR 2017/745
- Technical File
- Notified Bodies
- Authorized Representatives
- Custom Made Devices
- Clinical Evaluation & Clinical Investigation
- Systems & Procedure Packs
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