Updated on November 16, 2020
Medical Devices are devices that are used for various medical purposes, which include diagnosis, treatment and prevention of disease. These are regulated and approved for use by several bodies across the globe including the Food and Drug Administration (FDA) of the United States and the International Standards Organization (ISO). Medical Devices marketed in the European Union have to comply with the European Union Medical Device Regulation (EU MDR). The regulatory requirements for the devices vary according to their inherent risk, with stricter regulations for the devices posing a higher risk to the patient.
According to Article 51 of the EU MDR, medical devices are classified into four groups, class I, IIa, IIb and III. The classification is based on four factors, the duration of contact of the device, the degree of invasiveness, the anatomy affected, and whether the device is active or otherwise.
Class I medical devices pose the least risk to the patient.
Many of the class I devices are non-invasive, that is, they do not touch the patient, or touch only the intact skin, or act as a protective cover for wounds on the skin or mucous membranes. These devices include the following:
- Devices that do not touch the patient, like syringes or infusion sets, which are connected through a needle to the patient. These are channels to administer medications by gravity. Urine collection bags and ostomy pouches are also included in this group
- Devices that touch only intact skin like the stethoscope, frames for spectacles with corrective glasses, and electrodes for ECG or EEG machines
- Dressings for wounds such as absorbent pads, cotton wool, adhesive bandages and gauze dressings, whose sole purpose is to protect, compress the wound and/or absorb secretions from the wound
Some invasive devices are classified as class I devices
Invasive devices, which are introduced into the body through a natural or a surgical opening or placed on the eyeball, and intended to be used for less than an hour at a stretch are classified as class I devices. These should not be attached to an active device of a higher class. They include the following.
- Devices passed through the mouth which include:
- Devices used in dentistry like handheld mirrors, dental impression materials, impression trays, materials for manufacturing dentures
- Tubes used for pumping the stomach
- Devices passed through the anus like
- Enema devices
- Devices passed through the urethra like:
- Urinary catheters for transient use
- Prostatic balloon dilation catheters
Select invasive devices for short-term use, that is, those intended to be used continuously for between 60 minutes and 30 days in the mouth as far as the throat, in the ear canal or in the nasal cavity, for example, dressings for nasal bleeds, are also classified as class I devices.
Some reusable surgical equipment (Ir), sterile devices (Is) and measuring (Im) devices are classified as class I devices.
Reusable surgical instruments (Ir) like scalpels and scalpel handles, retractor forceps and sternum retractors are included under class I devices. These, along with the sterile (Is) and measuring (Im) devices, have to be certified through a notified body, who has to confirm the establishment, securing and maintenance of sterile conditions of sterile devices, the measuring function of the measuring devices, and aspects relating to the reuse in case of the reusable surgical instruments. This is in contrast to the other class I devices, which can be certified without the involvement of the notified body.
Some active devices are classified under class I medical devices.
Some active devices, which pose the least risk to the patient, are categorized as class I medical devices. Active devices depend on a source of energy or gravity for their operation. Active devices that do not fall in other groups can be classified as class I devices. These may include:
- Light sources used during diagnosis such as surgical microscopes or dental curing lights
- Devices that apply pressure such as Plaster of Paris and cervical collars
- Devices that provide external support such as hospital beds, stretchers and wheelchairs.
Software is often classified as class I with exceptions.
Software is classified as class I except if it intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, or monitor physiological parameters, or if such decisions could result in serious consequences, and even death.
This article is for informational purposes only and not intended to replace the relationship between the doctor and the patient. It should not be used for self-treatment by patients or by doctors to treat patients. Consult your doctor before using any of the above information.
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