Information about the Information that is supplied with the Essential Principle all information must be provided in English device, including copies device or used to promote the use of the 13, Schedule 1 of the labelling and Instructions for Use are not necessarily required of the: device in . Regulations for every model or variant, unless there are significant label Section 12. differences in content. The copies provided must be Information about a representative Instructions for Use medical device include a document that lists the addresses where the device is advertising material advertised on the Internet. such as brochures, web pages, advertisements Risk Management Report The Essential Principles require a Essential Principles, The Risk Management Report required by the current accepted manufacturer to conduct a risk analysis Schedule 1 of the version of ISO14971 is acceptable. to evaluate the known and foreseeable Regulations risks of using a device and ensuring that Section 3. The any undesirable side-effects are Essential Principles minimised and acceptable, when weighed against the benefits of the intended performance of the device Clinical evaluation A report that contains a comprehensive Essential Principle Evidence to support the clinical competence of the author must be report analysis of the clinical data relating to 14, Schedule 1 of the provided, such as a short curriculum vitae the device. The report should be Regulations objective and be prepared by an expert Part 8, Schedule 3 of in the field relevant to the intended use the Regulations of the device. Section 3. The Essential Principles Efficacy and Data that provides evidence that the Essential Principles, TGO 54 Therapeutic Trial Order No. 54—Standard for Disinfectants performance data for devices meet relevant efficacy and Schedule 1 of the and Sterilants is a standard that may be used to demonstrate medical devices intended performance requirements Regulations compliance with the relevant Essential Principles but it is not a by the manufacturer to mandatory standard Section 3. The be used for disinfecting Essential Principles including sterilisation of another medical device (for example, instrument
Information about the device, including copies of the: label Instructions for Use advertising material such as brochures, web pages, advertisements Information that is supplied with the device or used to promote the use of the device in . Essential Principle 13, Schedule 1 of the Regulations Section 12. Information about a medical device all information must be provided in English labelling and Instructions for Use are not necessarily required for every model or variant, unless there are significant differences in content. The copies provided must be representative include a document that lists the addresses where the device is advertised on the Internet. Risk Management Report The Essential Principles require a manufacturer to conduct a risk analysis to evaluate the known and foreseeable risks of using a device and ensuring that any undesirable side-effects are minimised and acceptable, when weighed against the benefits of the intended performance of the device Essential Principles, Schedule 1 of the Regulations Section 3. The Essential Principles The Risk Management Report required by the current accepted version of ISO14971 is acceptable. Clinical evaluation report A report that contains a comprehensive analysis of the clinical data relating to the device. The report should be objective and be prepared by an expert in the field relevant to the intended use of the device. Essential Principle 14, Schedule 1 of the Regulations Part 8, Schedule 3 of the Regulations Section 3. The Essential Principles Evidence to support the clinical competence of the author must be provided, such as a short curriculum vitae Efficacy and performance data for medical devices intended by the manufacturer to be used for disinfecting including sterilisation of another medical device (for example, instrument Data that provides evidence that the devices meet relevant efficacy and performance requirements Essential Principles, Schedule 1 of the Regulations Section 3. The Essential Principles TGO 54 Therapeutic Order No. 54—Standard for Disinfectants and Sterilants is a standard that may be used to demonstrate compliance with the relevant Essential Principles but it is not a mandatory standard Trial
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