Hitec Medical MDR training - Product classification under MDR （Part 2）

Source:    Published:2023-12-29     Hist:

Rule 10. Diagnostic and testing equipment

Equipment used for lighting (examination lamps, surgical microscopes) Class I；

For imaging of radiopharmaceuticals in the body (gamma camera) or for direct diagnosis or detection of important physiological processes (electrocardiogram, brain motor, electronic blood pressure measuring instrument) Class IIa；

Used for monitoring physiological functions in hazardous situations (blood gas analyzers during surgery) or emitting ionizing radiation and used for diagnosis or treatment (X-ray diagnostic machines,) Class IIb.

Rule 11. Software used to provide decision-making information for diagnostic or therapeutic purposes Class IIa

Rule 12. Active devices that control the entry and exit of drugs or other substances into the human body Class IIa (aspirators, supply pumps)

Such as work in a potentially dangerous way (narcotics, ventilators, dialysis machines) Class IIb

Rule 13. All other active medical devices belong to Class I

Such as: observation lamp, dental chair, electric wheelchair, electric bed

Special Rules

Rule 14. Devices containing auxiliary medicines and human blood extracts as components Class III

Such as: antibiotic bone cement, antibiotic-containing root canal treatment materials, catheters coated with anticoagulants

Rule 15, family planning equipment

All devices used for contraception or to prevent the transmission of sexually transmitted diseases (contraceptives) Class IIb;

Implantable or long-term invasive devices (tubal ligation devices) Class III

Rule 16. Cleaned or sterilized instruments

All equipment used exclusively for disinfection or disinfection is classified as Class IIa;

All equipment designed specifically for the disinfection, cleaning, and rinsing of hydrated contact lenses are classified as Class IIb.

Rule 17. Equipment for recording X-ray diagnostic images Class IIa

Rule 18, equipment manufactured from tissues, cells or derivatives of human or animal origin, Class III

Such as animal-derived biological heart valves, xenograft dressings, collagen dermal fillers

Rule 19. All devices incorporating or containing nanomaterials

with potential for high or moderate internal exposure (degradable bone-filling nanomaterials) Class III;

Exhibiting low internal exposure potential (nano-coated bone fixation screws) Class IIb;

Exhibits negligible potential for internal exposure (dental filling materials, non-degradable nanopolymers) Class IIa

Rule 20. Invasive devices intended to administer drugs by inhalation

All invasive devices concerning orifices of the body (inhalants for nicotine replacement therapy) Class IIa;

Unless the mode of action has a significant effect on the effectiveness and safety of the medicinal product administered and those intended for the treatment of life-threatening conditions Class II b

Rule 21. Devices consisting of substances introduced through an orifice of the body or applied to the skin

If they, or their metabolites, are absorbed in the stomach or lower gastrointestinal tract or body system, the purpose has been achieved (sodium alginate, xyloglucan) Class III;

Applied to the skin, nasal cavity, and oral cavity above the pharynx and to achieve their intended purpose in these cavities (nasal and throat sprays,) Class IIa;

In all other cases (oral activated coal, hydrated eye drops) Class IIb

Rule 22. Active treatment equipment with integrated diagnostic capabilities

Active therapeutic devices (automatic closed-loop insulin delivery systems, automated external defibrillators) with integrated or combined diagnostic functions that are the main factor in patient treatment with the device (automated external defibrillators) Class III