Differences between Australian Essential Principles and EU Essential Requirements.
Information & Training. | Medical DevicesThe Australian Essential Principles are specified in Schedule 1 of the Regulations. The analogous requirements in the EU are referred to as the Essential Requirements and are specified in Annex I of the MDD. The following table compares the Australian Essential Principles with the EU Essential Requirements.
Despite the differences, and with the exception of some medical device manufacturers who require a TGA Conformity Assessment Certificate, CE Certificates can be submitted in support of an application to include medical devices in the ARTG.
|EP 1 (and EP 2a)Australian EP 1 addresses the need to consider technical knowledge, experience, education or training of users. Australian EP 2a requires identification of hazards and risks arising from the use and foreseeable misuse of the device. The manufacturer must minimise any risks associated with the use of the device
|ER 1Directive 2007/47/EC introduces more explicit requirements to ER 1, which are similar to EP 1 and EP 2a.That is, reduce risk of use error due to ergonomic features of the device and consider the technical knowledge, experience, education and training of intended users while designing the device.
|EP 7.1 (a)EP 7.1(a) requires that “particular attention must be given to the chemical and physical properties of the materials used in the device”. Moreover, ISO 10993-1: Biological evaluation of medical devices – Part 1 Evaluation and testing, which is included in the Medical Device Standards Order (Standards for Biological Safety Of Medical Devices) 2008 refers to the consideration of physical characteristics and properties in the selection of materials. The requirement of biophysical or modelling research is not explicitly covered in the Australian EPs.
|ER 7.1Directive 2007/47/EC clarifies requirements in ER 7.1:‘particular attention must be paid to: where, appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.’
|EP 7.4—Verification of incorporated substance.
|ER 7.4Please see Section 14. Medical devices incorporating a medicine for more details.
|EP 7.5—Minimisation of risks associated with leaching substances and EP 7.6—Minimisation of risks associated with ingress or egress of substances.
|ER 7.1, 7.5 and 7.6Risks associated with leaching, egress or ingress of material or substances are addressed by the combination of the EU MDD ERs 7.1, 7.5 and 7.6.
|EP 7.5 and 7.6Controls for substances that are carcinogenic, mutagenic or toxic to reproduction are addressed in Australia by the general risk management requirements of EP 2. Users must be informed of any residual risks remaining after design-based risk removal or risk reduction is employed.
|ER 7.5 (substances that are carcinogenic, mutagenic, or toxic to reproduction)Directive 2007/47/EC added the additional requirement to ER 7.5:‘special attention shall be given to substances that are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex 1 to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations, packaging and labelling of dangerous substances.’
|EP 7.5 and 7.6There are no specific labelling requirements for medical devices containing phthalates in Australia. However, the general requirements of EP 2 apply (see above).
|ER 7.5. (phthalates)Directive 2007/47/EC also added: ‘If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates.If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.’
|EP 8.2—Control of animal, microbial, or recombinant tissues, cells, and other substances.
|ER 8.2Please see Section 15. Medical devices containing materials of animal, microbial or recombinant origin for more details.
|EP 10—Medical devices with a measuring function. The Australian EP 10.1(3) requires that measurements must be expressed in Australian legal units of measurement; or; if the device measures a physical quantity that is not prescribed under the National Measurement Act 1960, the units used are to be approved by the TGA.
|ER 10.3In the EU, ER 10.3 states that the measurements must be expressed in legal units conforming to the provisions of the Council Directive 80/181/EEC.
|EP 12.1The software development lifecycle is not explicitly addressed in the Australian EPs. EP 12.1 addresses other requirements for medical devices incorporating electronic programmable systems. See Section 13. Active medical devices for more details on medical device software requirements.
|ER 12.1(a)Directive 2007/47/EC introduced additional requirements to ER 12.1(a):‘for devices which incorporate software, or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’
|EP 13.1—Information to be provided with medical devices—general. The Australian EP 13.1(3) requires that the information must be provided in English and may also be provided in any other language. The Australian EP 13.1(5) requires that any number, letter, symbol, or letter or number in a symbol, used in the information to be legible and at least 1 millimetre high.
|ER 13Article 4 (4) of the MDD allows individual Member States to require the information made available to the user and the patient in accordance with ER 13, to be in a national language. In the EU the equivalent dimensional requirements are addressed in the standard EN1041—Information supplied by the manufacturer of medical devices.
|EP 13.3—Information to be provided with medical devices—particular requirements. Australian EP 13.3, items 12 and 13 require that the label displays either a date up to which the device can be safely used (if applicable) or the date of manufacture of the device.
|ER 13.3In the EU, a use by date by which the device should be used (where appropriate) is required (ER 13.3 (e)).Active devices in the EU require the year of manufacture if the device does not have a use by date (ER 13.3 (i)).
|EP 13.4—Instructions for use must include: Item 18 For a device that is intended by the manufacturer to be installed with, or connected to, another medical device or other equipment so that the device can operate as required for its intended purpose—sufficient information about the device to enable the user to identify the appropriate other medical device or equipment that will ensure a safe combination
|ER 9.1The EU has an equivalent requirement under ER 9.1: any restrictions on use, in relation to other devices or equipment, must be indicated on the label or in the instructions for use.
|EP 13.4—Instructions for use must include: Item 25 Information about any medicine (including any stable derivative of human blood or blood plasma) that is incorporated, or is intended to be incorporated, into the device as an integral part of the device
|ER 13.3EU ER 13.3 (n) requires that devices incorporating human blood derivative must indicate this on the label. Including this information in separate instructions for use is insufficient in the EU.
|EP 14Australian EP 14 requires that every medical device have clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the Essential Principles
|ER 6(a)Directive 2007/47/EC added ER 6(a):‘demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.’ Previously this requirement was addressed in ER 14. Now ER 14 is removed.
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