Medical Device

A medical device, as widely understood, is a product or instrument used for health purposes. To sit within that category, the product or instrument must meet specific criteria. Products that meet the criteria below are classified as medical devices.

A medical device carries a defined set of characteristics. The list is as follows:

• Use against disease
• Use in disease prevention
• Use in diagnosis of disease
• Use in treatment of disease
• Reduction of disease effects
• Monitoring of disease progression
• Use in injuries
• Diagnosis of injury
• Treatment of injury
• Relief of pain from wounds
• Monitoring of injury progression
• Support for the injured person's daily activities
• Meeting the human anatomical needs
• Investigation of the functioning of human anatomical features
• Devices that can replace anatomical structures
• Devices that improve anatomical structures
• Devices that support anatomical structures
• Maintaining the continuity of physiological functions
• Investigation of human physiological functions
• Replacement of physiological functions
• Improvement of physiological functions
• Support of physiological functions
• Providing life support
• Monitoring of pregnancy
• Disinfection of medical devices
• Examination of parts taken from the human body
• Medical devices may include:
• Instruments
• Applications
• Substances implanted in the body
• Machines
• Software
• Materials
• Adjusting devices
• Apparatus
• Culture-medium reagents
• Related writings
• Products with pharmacological, immunological, or metabolic effects are not classified as medical devices. However, such products may be used as auxiliaries alongside medical devices.

Active medical devices

Medical devices that require electrical energy or another energy source to operate are called active medical devices. (Devices that operate through the human body itself or through gravity alone do not fall under this definition.)

Implantable medical devices

An implantable medical device:

• A device that is placed, partially or fully, through the body's natural openings or through surgery, and is expected to remain in the body for at least 30 days
• A device placed on the surface of epithelial tissue or on the eye surface, and expected to remain at the site of placement for 30 days or more

For a medical device to be classified as implantable, it must be placed in the body through surgical or medical procedures and removed through equivalent procedures.

Active implantable medical devices

An implantable medical device:

A medical device that operates on electrical energy and is placed, partially or fully, through the body's natural openings or through surgery, and is expected to remain at the site of placement after the medical procedure.

Sterile medical devices

A sterile medical device is one that has been cleared of live bacteria, microorganisms, and their spores. The requirements that sterile medical devices must meet are generally defined in national and regional standards and regulations.

Important

Organisations often issue advisory notices after delivering medical devices. These advisory notices provide additional information about the medical devices produced. Advisory notices must cover:

• The use of the medical device
• The improvement of the medical device
• The disposal of used medical devices
• The recycling of the medical device.
• National and regional regulations generally require firms to use advisory notices.

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