Medicines (Database of Medical Devices) Regulations 2003

Schedule 2
Medical devices risk classification rules

rr 3, 12, 13

1 Interpretation

  • For the purposes of this schedule,—

    • (a) a medical device is intended for transient use if the manufacturer intends the device to be used continuously for less than 60 minutes:

    • (b) a medical device is intended for short-term use if the manufacturer intends the device to be used continuously for at least 60 minutes but not more than 30 days:

    • (c) a medical device is intended for long-term use if the manufacturer intends the device to be used continuously for more than 30 days.

Rules for classifying non-invasive medical devices

2 Medical devices in general

  • A non-invasive medical device is classified as Class I, unless the device is classified at a higher level under another clause of this schedule.

3 Non-invasive medical devices intended to channel or store blood, etc

  • (1) This clause applies to—

    • (a) a non-invasive medical device that is intended by the manufacturer to be used to channel or store blood or body liquids that are to be infused, administered, or introduced into a person; and

    • (b) a non-invasive medical device that is intended by the manufacturer to be used to store an organ, part of an organ, or body tissue, that is to be later introduced into a person; and

    • (c) a non-invasive medical device that—

      • (i) is intended by the manufacturer to be used to channel or store a liquid or gas that is to be infused, administered, or introduced into a patient; and

      • (ii) may be connected to an active medical device classified as Class IIa or higher.

    (2) A medical device to which this clause applies is classified as Class IIa.

4 Non-invasive medical devices intended to modify the biological or chemical composition of blood, etc

  • (1) A non-invasive medical device that is intended by the manufacturer to be used to modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, is classified as Class IIb.

    (2) Despite subclause (1), if the treatment for which the medical device to which this clause applies is designed consists of filtration, centrifugation, or exchanges of gas or heat, the device is classified as Class IIa.

5 Non-invasive medical devices intended to have contact with injured skin

  • (1) This clause applies to a non-invasive medical device that is intended by the manufacturer to be used in contact with injured skin (including a device the principal intention of which is to manage the micro-environment of a wound).

    (2) A medical device to which this clause applies is classified as Class IIa.

    (3) Despite subclause (2), a medical device to which this clause applies is classified as Class I if it is intended to be used—

    • (a) as a mechanical barrier; or

    • (b) for compression; or

    • (c) for the absorption of exudates.

    (4) Despite subclause (2), if a device to which this clause applies is intended to be used principally for wounds that have breached the dermis and the wounds can only heal by secondary intent, the device is classified as Class IIb.

Rules for classifying invasive medical devices and implantable medical devices

6 Invasive medical devices intended to be used by penetration of body orifices

  • (1) This clause applies to an invasive medical device (other than a surgically invasive medical device) that is intended by the manufacturer to be used to penetrate a body orifice of a patient.

    (2) If a medical device to which this clause applies is not intended to be connected to an active medical device, the following rules apply:

    • (a) if the device is intended for transient use, the device is classified as Class I:

    • (b) if the device is intended for short-term use, the device is classified as Class IIa unless the device is intended to be used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum, or in a nasal cavity, in which case the device is classified as Class I:

    • (c) if the device is intended for long-term use, the device is classified as Class IIb unless the device is intended to be used in the oral cavity as far as the pharynx, or in an ear canal up to the ear drum, or the device is intended to be used in a nasal cavity and the device is not liable to be absorbed by the mucous membrane, in which case the device is classified as Class IIa.

    (3) Despite subclause (2), if a medical device to which this clause applies is intended to be connected to an active medical device that is classified as Class IIa or higher, the device is classified as Class IIa.

7 Surgically invasive medical devices intended for transient use

  • (1) This clause applies to a surgically invasive medical device that is intended for transient use.

    (2) A medical device to which this clause applies is classified as Class IIa.

    (3) Despite subclause (2), if a medical device to which this clause applies is intended by the manufacturer specifically to be used to diagnose, monitor, control, or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body, the device is classified as Class III.

    (4) Despite subclause (2), if a medical device to which this clause applies is a reusable surgical instrument, the device is classified as Class I.

    (5) Despite subclause (2), a medical device to which this clause applies is classified as Class IIb if—

    • (a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or

    • (b) the device is intended by the manufacturer to have a biological effect; or

    • (c) the device is intended by the manufacturer to be wholly, or mostly, absorbed by the patient's body; or

    • (d) the device is intended by the manufacturer to be used to administer medicine to a patient by means of a delivery system, and the administration is potentially hazardous to the patient having regard to the characteristics of the device.

8 Surgically invasive medical devices intended for short-term use

  • (1) This clause applies to a surgically invasive medical device that is intended for short-term use.

    (2) A medical device to which this clause applies is classified as Class IIa.

    (3) Despite subclause (2), a medical device to which this clause applies is classified as Class IIb if—

    • (a) the device is intended by the manufacturer to be used to supply energy in the form of ionising radiation; or

    • (b) the device is intended by the manufacturer to undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth; which is classified as Class IIa); or

    • (c) the device is intended by the manufacturer to administer medicine.

    (4) Despite subclause (2), a medical device to which this clause applies is classified as Class III if the device is intended by the manufacturer—

    • (a) specifically to be used to diagnose, monitor, control, or correct a defect of the heart, or the central circulatory system, of a patient through direct contact with these parts of the body; or

    • (b) specifically to be used in direct contact with the central nervous system of a patient; or

    • (c) to have a biological effect; or

    • (d) to be wholly, or mostly, absorbed by a person's body.

    (5) For the purposes of this clause and clause 9, a medical device that is intended by the manufacturer to be placed in the teeth—

    • (a) includes a medical device that is intended by the manufacturer to penetrate a tooth; but

    • (b) does not include a medical device that is intended by the manufacturer to penetrate a tooth and enter the gum or bone beyond the tooth.

9 Surgically invasive medical devices intended for long-term use and implantable medical devices

  • (1) This clause applies to—

    • (a) a surgically invasive medical device that is intended for long-term use; and

    • (b) an implantable medical device.

    (2) A medical device to which this clause applies is classified as Class IIb.

    (3) Despite subclause (2), if a medical device to which this clause applies is intended by the manufacturer to be placed in the teeth, the device is classified as Class IIa.

    (4) Despite subclause (2), a medical device to which this clause applies is classified as Class III if the device is intended by the manufacturer—

    • (a) to be used in direct contact with the heart, the central circulatory system, or the central nervous system of a patient; or

    • (b) to have a biological effect; or

    • (c) to be wholly, or mostly, absorbed by a person's body; or

    • (d) to undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth; which is classified as Class IIa); or

    • (e) to be used to administer medicine.

Special rules for classifying active medical devices

10 Active medical devices in general

  • An active medical device is classified as Class I, unless the device is classified at a higher level under another clause in this schedule.

11 Active medical devices for therapy

  • (1) An active medical device for therapy that is intended by the manufacturer to be used to administer energy to a patient, or exchange energy to or from a patient, is classified as Class IIa.

    (2) Despite subclause (1), if a device referred to in subclause (1) is of a kind such that the administration or exchange of energy occurs in a potentially hazardous way, having regard to the nature, density and site of application of the energy, the device is classified as Class IIb.

    (3) Despite subclause (1), an active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active medical device for therapy of the kind referred to in subclause (2) is classified as Class IIb.

12 Active medical devices for diagnosis

  • (1) This clause applies to an active medical device for diagnosis.

    (2) A medical device to which this clause applies is classified as Class IIa if—

    • (a) the device is intended by the manufacturer to be used to supply energy that will be absorbed by a patient's body (other than a device that is intended only to illuminate the patient's body in the visible spectrum; which is classified as Class I); or

    • (b) the device is intended by the manufacturer to be used to image in vivo distribution of radiopharmaceuticals in a patient; or

    • (c) the device is intended by the manufacturer to be used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than a device of a kind mentioned in subclause (3)(a)).

    (3) A medical device to which this clause applies is classified as Class IIb if—

    • (a) the device is intended by the manufacturer specifically to be used to monitor vital physiological parameters of a patient, and the nature of the variations monitored is of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system); or

    • (b) the device is intended by the manufacturer to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology; or

    • (c) the device is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of a device of the kind mentioned in paragraph (b).

13 Active medical devices intended to administer or remove medicines, etc, from patient's body

  • (1) An active medical device that is intended by the manufacturer to be used to administer medicine, body liquids, or other substances to a patient, or to remove medicine, body liquids, or other substances from a patient, is classified as Class IIa.

    (2) However, if a device referred to in subclause (1) is of a kind such that the administration or removal of the medicine, body liquids, or other substances is potentially hazardous to the patient, having regard to the nature of the substances involved, the part of the patient's body concerned, and the characteristics of the device, the device is classified as Class IIb.

Special rules for classifying particular kinds of medical devices

14 Medical devices incorporating a medicine

  • (1) This clause applies to a medical device of any kind that incorporates, or is intended to incorporate, as an integral part, a substance that,—

    • (a) if used separately, would be a medicine; and

    • (b) is liable to act on a patient's body with action ancillary to that of the device.

    (2) A medical device to which this clause applies is classified as Class III.

    (3) For the purposes of this clause, any stable derivative of human blood or human plasma is to be treated as a medicine.

15 Medical devices intended for contraception or prevention of sexually transmitted diseases

  • (1) A medical device that is intended by the manufacturer to be used for contraception, or the prevention of sexually transmitted diseases, is classified as Class IIb.

    (2) Despite subclause (1), if a medical device referred to in that subclause is an implantable medical device or an invasive medical device that is intended for long-term use, the device is classified as Class III.

16 Medical devices intended for disinfecting, cleaning, etc

  • (1) A medical device that is intended by the manufacturer specifically to be used for disinfecting, cleaning, rinsing, or hydrating contact lenses is classified as Class IIb.

    (2) A medical device that is intended by the manufacturer specifically to be used for disinfecting another medical device is classified as Class IIb.

    (3) This clause does not apply to a medical device that is intended by the manufacturer to be used only to clean another medical device (other than contact lenses) by means of physical action; which is classified as Class I.

17 Non-active medical devices intended to record x-ray diagnostic images

  • A non-active medical device that is intended by the manufacturer to be used to record x-ray diagnostic images is classified as Class IIa.

18 Medical devices containing non-viable animal tissues, cells, or other substances, or microbial or recombinant tissues, cells, or other substances

  • (1) This clause applies to a medical device if the device contains—

    • (a) tissues, cells, or substances of animal origin that have been rendered non-viable, or tissues, cells, or substances of microbial or recombinant origin; or

    • (b) a combination of tissues, cells, or substances of the kind described in paragraph (a).

    (2) A medical device to which this clause applies is classified as Class III, unless—

    • (a) the device contains only tissues, cells, or substances of animal origin that have been rendered non-viable; and

    • (b) the device is intended by the manufacturer to come into contact with intact skin only.

    (3) A medical device to which subclause (2)(a) or (b) applies is classified as Class I.

19 Medical devices that are blood bags

  • A medical device that is a blood bag is classified as Class IIb.

20 Active implantable medical devices

  • (1) An active implantable medical device is classified as Class AIMD.

    (2) An implantable accessory to an active implantable medical device is classified as Class III.

    (3) An active medical device that is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of an active implantable medical device is classified as Class III.

21 Medical devices intended for export only

  • A medical device that is intended by the manufacturer to be for export only is classified as Class I.

22 Medical devices that are mammary implants

  • A medical device that is a mammary implant is classified as Class III.

Diane Morcom,
Clerk of the Executive Council.