Definition of a medical device within the meaning of Regulation (EU) 2017/745 of 5 April 2017 (Medical Device Regulation - MDR)

“‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, 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 change in anatomy or of a physiological or pathological process or condition 
• providing information by means of an 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 sterilization of ‘medical devices’”  
   

Head of MP Studies

Process Manager