What is a medical device and what are the different classes of Medical Devices?

A medical device can be defined as any device that is used by human beings to diagnose and cure a disease or illness in the human body. Also, a medical device can be termed as anything that is created or adopted by a human for a medical purpose only. According to EU MDR, ‘medical device’means any instrument, apparatus, appliance, software, implant, reagent, material, or any other article intended by the manufacturer to be used, alone or in combination, by human beings for one or more of the following medical purposes –

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  • Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury, or disability.
  • Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state.
  • Providing information by means of an in-vitro examination of specimens derived from the human body, including organ, blood, or tissue donation, and which does not achieve its principal intended actions by a pharmacological, immunological, or metabolic means in or on the human body, but which may be assisted in its function by such means.

 

The following product shall also be deemed to be medical devices –

  • Devices for the control or support of conception.
  • Products specifically intended for cleaning, disinfection, or sterilization of products as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Some examples of medical devices are – Bandages, thermometers, wheelchairs, pacemakers, sutures, facemasks, surgical instruments, Blood pressure monitoring machines, syringes, CT Scanners, ECG Machines, and many more.

  • Classification of Medical Device

Classification of the Medical Device CE Marking device is used to determine the level of harm they can pose to the end-user, namely the patient. Also, the classification of the medical device is important because it will help the manufacturer determine what must be done before selling the product and it will help the manufacturer to get an estimate of the overall cost and time required to bring a medical device into the market.

Based on risk management, medical devices are classified into five different classes as per EU MDR –

  1. Class I (Basic): Those medical devices which are low risk and are non-sterile and with no measuring function.

Examples – Earbuds, hospital beds, bedpans, plasters, manual wheelchairs, corrective glasses, and frames.

  1. Class I (Special function):Those medical devices which are of low to medium risk and are sterile and with measuring function.

Class I can be further subdivided into -

    Examples – personal protection Kit, sterile urine bags

  • Class Im –Those medical devices have a measuring body function.

     Examples – Thermometers, weighing scales, stethoscopes.

  • Class Ir – Those medical devices that are processed or reused.

           Examples – Endoscopes, surgical instruments.

  1. Class IIa:Those medical devices which are of medium risk and are used by patients for 60 minutes to 30 days.

Examples - Catheters, Orthodontic wires, Hearing aids, surgical clamps.

  1. Class IIb:Those medical devices which are of medium to high risk and are used by the patients for longer than 30 days.

Examples – Non-absorbable sutures, Surgical lasers, Intraocular lenses, incubators for babies.

  1. Class III:Those medical devices which are of the highest risk and permanent monitoring is essential during the lifetime of these devices.

Examples -Prosthetic heart valves, Pacemakers Cardiovascular sutures, spinal needles.

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