Medical devices

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These range from external equipment for measurement to implants. The borderline areas and rather complicated subclassification regimes differ with jurisdictions. The approval process and likely use permissions also vary by jurisdiction. Generally it is less rigorous and the approved product can be used by a wider range of health care practitioners than for medicinal products. For example many FDA approved cardiovascular devices have little or no evidence from randomised clinical trials [1] a situation likely to pertain in other jurisdictions where the same devices are used !. Also something like an injection of normal saline, if it is classified as a medical device, does not need to be prescribed by someone with prescribing rights.

The range of medical devices includes:

  • Alcohol wipes, bandages, dental materials (but for example in EU antiseptic wipes become borderline with medicinal products)
  • Tongue depressors, spectacles
  • Breast implants, hip prostheses, heart valves, stents
  • ECGs, pressure monitoring equipment, X-ray equipment
  • Standalone software used for medical diagnostic and therapeutic purposes
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Defined by 93/42/EEC

...means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings 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,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;...

During 2010 the essential requirements which medical devices must satisfy in order to be lawfully placed on the market will have to comply with 2007/47/EC

This directive is expected to be replaced in early 2017 and indeed the replacement was approved in June 2016 and is now going through the process of finalisation. See EU Revisions of Medical Device Directives

Stand alone software specific guidance is at http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf

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See FDA Defined as

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 it's 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...
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See:

It is expected that new Medical Device Regulations will become law in May 2017. Over a three year time frame from then there will be changes. For example each medical device is likely to have a unique European identifier and at the moment medical devices developed in house for an NHS organisation and never marketed are exempt from the regulation but this may change in certain details.

References

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