Medical Devices

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As a leading International Medical and Technology recruitment consultancy Remtec is pleased to provide information on the Medical Device industry

The global medical device industry is estimated to be valued in excess of $250 billion, employing many hundreds of thousands of people (over 400 000 people in Europe alone), and growing at between 5 and 6% per annum. It is a highly dynamic environment in which to work, with high investment in R&D, and where products tend to have an average product lifecycle of only 18 months before an improved product becomes available. Management structures tend to be typically quite flat in order that the organisations can be responsive to rapid changes in the market. Those employed in this industry are, as a consequence, highly trained and innovative.

When a medical device is applied to the body the effect is physical, in contrast to pharmaceutical drugs, which exert a biochemical effect. Below are the European Union and Food & Drug Administration (FDA), definitions of what a medical device is:

European Union definition

Directive 2007/47/ec of the European Parliament and of the council of 5 September, 2007, which amended the Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices, defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings.

Devices are to be used for the purpose of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.
  • Investigation, replacement or modification of the anatomy or of a physiological process.
  • Control of conception

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Definition in USA by the Food and Drug Administration

A medical device, according to the U.S. Food and Drug Administration (FDA), is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

As defined by the Federal Food, Drug, and Cosmetic Act, 21 United States Code [321] (h). Medical devices are regulated by the FDA Center for Devices and Radiological Health (CDRH).

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Medical Device Classifications

Medical devices in the European Union are divided into four classes, ranging from low risk to high risk.

  • Class I - Low Risk
    • Devices in this category include tongue depressors, bedpans, elastic bandages, most hand-held dental instruments, examination gloves, and hand-held surgical instruments and other similar types of common equipment.
  • Class II - Medium Risk
    • Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user.
  • Examples of Class IIa devices:
    • Hearing aids
    • Electrocardiography
    • Ultrasonic diagnostic equipment
    • Examples of Class IIb devices:
    • Surgical lasers
    • Ventilators
    • Intensive care monitoring equipment
  • Class III - High Risk
    • Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants.

Examples of some of the leading medical device companies are:

Examples of medical device associations are: