Medical devices (MD)
Posts by ; their categories, their uses, their different classifications.
What is a medical device ?
We hear by medical device “any instrument, apparatus, equipment, matter, product, with the exception of products of human origin, or other item used alone or in combination, including the accessories and software necessary for its proper functioning, intended by the manufacturer for medical use in humans and whose major desired action is not obtained by pharmacological means. Software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes is also a medical device”.
Source : Publication of the French health code (article L.5211-1)
The definition of a medical device is common to all member states of the European Union (Article 1 of the Medical Device Directive). The medical devices market is very large and the sector very innovative. The industrial fabric is multiple and diversified, made up of both large multinationals and small and medium-sized companies.
Dressings, corrective lenses, condoms, thermometers, pacemaker, medical scanner : the term “medical device” (MD) brings together a very large number of products of various nature and destination. According to estimates by the World Health Organization (WHO), today we count approximately 10 000 categories of medical devices, either between 90 000 and 1,5 millions of different products whose safety and performance are guaranteed by European legislation.
The different classes of medical devices
Medical devices are classified according to the level of risk associated with their use (duration of use, exposed body part, inside or outside the body) and the potential public health risks associated with their use (class I to III).
I
Lowest risk class :
Compresses, glasses, the crutches,
etc.
II a
Moderate/measured potential risk :
Contact lenses, ultrasonic devices, dental crowns, etc.
II b
Potential high/significant risk :
Condoms, lens disinfection products, etc.
III
Highest risk class :
Breast implants, hip prostheses, stents, etc.