a well-reasoned and documented risk analysis evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 2 Protection against risks associated with heat A medical device must be designed and produced in a way that ensures that, during normal use, any accessible part of the device (other than any part intended by the manufacturer to supply heat or reach a given temperature), and any area surrounding an accessible part of the device, does not reach a potentially dangerous temperature. 12.11 Protection against risks associated with heat The work undertaken by the manufacturer could involve, but is not restricted to: a well-reasoned and documented risk analysis evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis From the Therapeutic (Medical Devices) Regulations 2002—Schedule 1, Part 2 Protection against risks associated with administration of energy or substances This clause applies in relation to a medical device that is intended by the manufacturer to be used to administer energy or a substance to a patient. The device must be designed and produced in a way that ensures that: the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented. The device must be fitted with a of indicating or, if appropriate, preventing inadequacies in the rate and amount of energy, or of the substance, administered that might cause danger to the patient, the user or any other person. The functions of each control and indicator on the device must be clearly specified on the device. If the instructions for the operation of the device, or the operating or adjustment parameters for the device, are displayed by means of a visual system incorporated into the device, the instructions or parameters must be able to be understood by the user and, if appropriate, the patient. 12.12 Protection against associated with administration of energy or substances The work undertaken by the manufacturer could involve, but is not restricted to: a well-reasoned and documented risk analysis ensuring that operational information displayed by the device is clearly understandable evidence of appropriate testing to confirm the design and production decisions resulting from the risk analysis
Rule 4.3 Description 4.3(2)(a) A device to supply energy that will be absorbed by a patient’s body (except a device that illuminates the patient’s body in the visible spectrum)—Class IIa. Examples: magnetic resonance equipment, pulp testers, evoked response stimulators, diagnostic ultrasound. 4.3(2)(b) A device to be used to image in vivo distribution of radiopharmaceuticals in patients—Class IIa. Examples: gamma cameras, positron emission tomography, single photon emission computer tomography. 4.3(2)(c) A device used for direct diagnosis or monitoring of vital physiological processes of a patient, excluding devices mentioned in the previous entry—Class IIa. Examples: electrocardiographs, electroencephalographs, cardioscopes with or without pacing pulse indicators, electronic thermometers. 4.3(3)(a) A device to monitor vital physiological parameters of a patient, and the nature of variations monitored could result in immediate danger to the patient—Class IIb. Please note: For this clause ‘variations monitored’, is taken to mean that the result of monitoring could lead to immediate danger to the patient. This is typically, but not always, accompanied by an alarm. Examples: intensive care monitoring systems, biological sensors, blood gas analysers used in surgery, cardioscopes and apnea monitors including those in home care. 4.3(3)(b) A device to emit ionising radiation and to be used for diagnostic or therapeutic interventional IIb. Examples: diagnostic x-ray sources, linear accelerators. 4.3(3)(c) A device to control, monitor or directly influence the performance of a device in the previous entry—Class IIb. Examples: auto exposure control systems, radiotherapy after controls systems. Rule 4.4 Active medical devices intended to administer or remove medicines, etc from a patient’s body This rule covers drug delivery systems and anaesthesia equipment. Rule 4.4 Description 4.4(1) An active device to administer or remove medicine, body liquids or other substances—Class IIa. Examples: suction equipment, feeding pumps, jet injectors for vaccination.
A device that is a mammary implant is classified as Class III. Classification examples The following examples are provided to demonstrate the importance of considering all the Classification Rules for a device to ensure that the device is appropriately classified. The examples will not include all the possible devices that may be on the market—they are intended to demonstrate how different variables affect the classification of a device. There may be several Classification Rules that apply to a device—if this happens the higher classification applies, with the exception of medical devices for export only (Rule 5.8), which are classified as Class I. Warming blanket Intended purpose: To re-warm patients who are cold (hypothermic or recovering post-surgery). These patients may be unconscious. Description Variable/comments Classification Rule Classification A large piece of fabric material blanket specially designed to keep a person warm and/or to prevent the further loss of body heat, often in an emergency situation Not powered Rule 2.1 I Blanket used to blow warm air onto patient in hypothermia, (person unable to regulate own body temperature) Electrically powered Potentially hazardous as patient may get burned or overheated; may have peripheral neuropathy (so not able to feel the intensity of the heat), may not be able to indicate if the blanket is too hot (e.g., neonates, unconscious patients). If a patient’s blood pressure is critically low when the therapy is first applied, the applied heat may be detrimental to maintaining adequate blood pressure, as resulting vasodilation reduces blood pressure Rule 4.2(2) Class IIb Nebuliser Intended purpose: To deliver particles of medication/moisture (typically bronchodilators such as salbutamol) to the airways and lungs. Description Variable/comments Classification Rule Classification A compressor that pumps compressed air through the fluid to be nebulised, thus forming droplets/vapour and Electrically powered Rule 4.4(1) Class IIa
Periodic surveillance audits will be performed by the TGA or EU Notified Body Part 5, Product quality management system A system encompassing the inspection and testing of a medical device Manufacturer must implement a quality management system (that is, ISO excluding clauses 7.3 and 7.5.2) and arrange for the quality management system to be audited by the TGA or a EU Notified Body. The TGA or EU Notified Body also reviews a sample of the manufacturer’s technical documentation for the devices. Class I (measuring), IIa, Class IIb Please note: can not be used for sterile devices Assessment can cover a wide range of devices—not limited to a specific device. For Class I (measuring) and Class IIa devices this only covers production—the design of each device still requires Part 6 conformity assessment. For Class IIb devices this only covers production—the design of each device still requires conformity assessment under Part 2. May be resource intensive to initially establish appropriate procedures. The quality management system must be maintained Periodic surveillance audits will be performed by the TGA or EU Notified Body Part 6, Declaration of Conformity (not requiring assessment by Secretary) Preparing technical documentation for a medical device and establish a post-market monitoring system Manufacturer ensures that the device(s) comply with the Essential Principles and prepares documentation that demonstrates conformity. Class I, Class I (measuring and/or sterile), Class IIa For Class I non-measuring and non-sterile devices the evidence (Declaration of Conformity) is not required to be submitted to the TGA but MUST be available upon request. For Class I (measuring and sterile) and Class IIa devices, conformity assessment under Part 3, Part 4 (sterile devices) or Part 5 is also required. Part 7, Conformity Assessment Procedures for devices used for a Special Purpose Applies to custom-made medical devices, systems and procedure packs All Please note: sterile systems and procedure also require Part 4 certification For custom-made medical devices, see Section 18. Custom-made medical devices. For systems and procedure packs, see Section 16. Systems and procedures packs.