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Hitec Medical MDR training - Product classification under MDR （Part1）

Source: Published:2023-12-22 Hist:

Based on the intended use of the product, it is divided into four risk levels: I, IIa, IIb, III (Class I can be subdivided into Is, Im, Ir, according to actual conditions; these three categories also require third-party certification before obtaining a CE certificate. IPO.)

The terms based on classification rules are adjusted from 18rules in the MDD period to 22rules

Classify products based on risk; when a medical device is subject to multiple rules, the highest level classification rule is used.

Temporary use	Refers to expected normal continuous use not exceeding 60 minutes
Short-term use	Refers to expected normal use between 60 minutes and 30 days.
Long-term use	Refers to expected normal continuous use for more than 30 days.
Body orifice	Any natural opening in the body, as well as the outer surface of the eyeball, or any permanent artificial opening, such as a stoma.
Surgical Invasive Instruments	Invasive devices that penetrate the body from the surface, including through mucous membranes of body orifices during surgery
Reusable surgical instruments	Refers to a device intended for surgical use by cutting, drilling, sawing, scraping, chipping, clamping, shrinking, shearing or similar means, which is not connected to any active medical device and can be reused after appropriate processing.
Active therapeutic equipment	Any active device, whether used alone or in combination with other devices, to support, alter, replace or restore biological function or structure for the purpose of treating or alleviating disease, injury or disability.
Active devices for diagnosis and testing	Refers to any active device, whether used alone or in combination with other devices, used to detect, diagnose, detect, or treat a physiological disorder, health condition, disease, or congenital malformation.
Central circulatory system	Refers to: pulmonary artery, ascending aorta, arch aorta, descending aorta with arterial bifurcation, coronary artery, common carotid artery, external carotid artery, internal carotid artery, cerebral artery, brachiocephalic trunk, cardiac vein, pulmonary vein, superior vena cava , inferior vena cava.
Central nervous system	refers to the brain, meninges and spinal cord

Rules 1 to 4. All non-invasive devices belong to Class I unless they:

For storage of blood or other body fluids (other than blood bags) Class IIa;

Use Class IIa in connection with active devices of Class IIa or higher;

Change in composition of body fluids category IIa/IIb, wound dressing category IIa/IIb.

Rule 5. Medical devices that invade the human body

Temporary application (dental compression materials, examination gloves) Class I;

Short-term use (catheters, contact lenses) Class IIa;

Long-term use (urethral stents) Class IIb.

Rules 6~8, surgical trauma instruments

Reusable surgical instruments (forceps, axes) Class I;

Temporary or short-term use (suture needles, surgical gloves) Class IIa;

Long-term use (pseudoarthrosis, lens) Class IIb;

Devices in contact with the central circulatory system or central nervous system Class III.

Rule 9. Devices that give or exchange energy Class IIa (muscle stimulators, electric drills, skin phototherapy machines, hearing aids)

Working in a potentially hazardous manner (high-frequency electrosurgery, ultrasonic lithotripter, infant incubator) Class IIb;

Emission of ionizing radiation for therapeutic purposes (cyclotron, linear accelerator) Class IIb;

All devices used to control, detect or directly affect the performance of active implantable devices (implantable defibrillators, implantable loop recorders) Class III.