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Regulations for Medical Devices

Regulations for Medical Devices
Regulations for Medical Devices

Medical devices can be anything from highly refined computerized medical equipment down to a wooden tongue depressor. There are multiple international classification components to categorize medical devices. The World Health Organization, or WHO, with partners, are working toward accomplishing global harmonization in medical device terminology in hopes of bringing a global standardization.


The Global Harmonization Task Force proposes the following definition for medical devices: A medical device is any instrument, implement, apparatus, machine, implant, appliance, in vitro reagent or calibrator, software, or related article, as intended by the manufacturer to get used in combination or alone on humans for the specific purpose of:


  • diagnosing, preventing, monitoring, alleviation or treatment of disease
  • diagnosing, monitoring, treating, alleviation or monetary compensation
  • investigating, replacing, modifying, or supporting the anatomy or physiological process
  • supporting and sustaining life
  • preventing conception
  • disinfecting medical devices

Accessory Classification

You should note that if an accessory is used by its maker to go with a specific medical device, it is subject to all of the same procedures that apply to the device itself. The definition, when it comes to in vitro examinations, includes reagents, sample collection devices, calibrators, control materials, and remaining instruments. The information that is provided by an in vitro diagnostic device could be used for diagnostic purposes, compatibility purposes, or for monitoring. Some jurisdictions have separate regulations for reagents and such.

Different Strokes for Different Folks

Some products are called medical devices in some places, but have not ended up with a uniform decision surrounding them in all places. These items include aids for those that are disabled or handicapped. Devices that can treat and diagnose the injuries and diseases of animals are another area that the FDA can regulate to help serve a purpose in the world. There are also devices used that incorporate animal tissue along with human tissue.


Make sure that you understand that the terms and regulations are legally binding and can have restricted meanings. Manufacturers, distributors, vendors, and retailers all have very precise definitions in regulations. The definitions can differ when it comes to regulations of alternative countries. A regulation commonly has a list of definitions of terms used. The shared definition of many important terms such as performance, effectiveness, incidents, and vigilance are all under development. Some common definitions are set aside, such as adverse event, which is a problem that results in injury, permanent impairment, or even death to the user or patient.


The effectiveness has to do with if a device is clinically effective and produces the intended effect of the manufacturer relative to the conditions. If a devise is needed for the relief of pain, one would expect it to actually relieve pain and would expect the manufacturer to possess objective evidence that proves that it does relieve pain. Effectiveness is often thought of as efficacy in clinical environments of the real world. Efficacy simply means effectiveness in a perfectly controlled setting.

Investigation Issues

Incidents considered an unusual or unexpected even that is associated with using medical devices must be reported. The incident may or may not lead to any problems. All incidents, however, are investigated for possible issues.

General Terms

A manufacturer is who produces medical devices. The performance means effectiveness, in addition to technical performance. Person includes any establishment. A problem is a very broad term that tries to cover any possible faults of the medical device. The item being difficult to use or getting an undesirable outcome when used is associated with the devices performance. Corrective or preventative actions may be required. A vendor is anyone who sells the medical device. This could be the manufacturer, importer, distributor, wholesaler, or retailer.

The World Health Organization has worked hard to try and make common lingo between all of the parties that work together in the world. They have a good start of harmonized definitions that will help start communication with those that do not even speak the same language.

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