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Medical devices: a definition


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Medical devices: a definition

Medical devices their definition, uses and features

In the French Public Health Code (articles L 5211-1 and R 5211-1) a medical device is defined as "being any instrument, apparatus, piece of equipment, material, product, except for products of human origin, or any article used alone or in combination, including the accessories and software required to make it function normally, designed by the manufacturer to be used for people for medical purposes and whose main desired effect cannot be secured by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means.

Medical devices are designed to be used for the following purposes:

1/ diagnosis, prevention, controlling, treatment or alleviation of an illness;
2/ diagnosis, controlling, treatment, alleviating or compensating for injuries or handicaps;
3/ studying, replacing or modifying body parts or physiological processes;
4/ controlling conception."

This definition applies to thousands of products (over 70,000) which are of extremely varied nature on account of their weight, size and production cost, but which all meet the same objectives: to prevent, diagnose, control and alleviate injuries, diseases and handicaps.

The medical technologies industry brings together a heterogeneous set of products covering an infinitely vast and widespread therapeutic and operational field: from syringes to MRI, from implantable cardiac defibrillators to wheelchairs, and so forth.

The medical devices sector, which is an indisputable element in structuring our healthcare system, is the second biggest supplier of healthcare goods and products.

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