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Clinical evidence guidelines: Medical devices
Appendix 2: Glossary and abbreviations
- Adverse event
- 25 any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
- NOTE 1: This includes events related to the investigational device or the comparator.
- NOTE 2: This includes events related to the procedures involved.
- NOTE 3: For users or other persons this is restricted to events related to the investigational medical device.
- Application audit
- The Act enables the Regulations to prescribe certain kinds of applications that are to be selected for audit. These kinds of applications must be selected for audit by the Secretary. However, the Secretary may also select for auditing any other application under section 41FH of the Act. The TGA has established two levels of application audit, Level 1 and Level 2:
- Level 1: Targeted for completion within 30 days - The TGA will consider:
- the original or correctly notarised copy of the manufacturer's Australian Declaration of Conformity
- Copy of the latest and current conformity assessment evidence for the medical device
- Information about the device, including copies of the label, instructions for use and advertising material such as brochures, web pages and advertisements
- Level 2: Targeted for completion within 60 days - The TGA will consider all of the documentation considered in a Level 1 audit. In addition, the TGA will consider:
- the risk management report
- the clinical evaluation report
- efficacy and performance data for medical devices that disinfect including those that sterilise other medical devices.
- Level 1: Targeted for completion within 30 days - The TGA will consider:
- a medically qualified person who reviews the clinical evaluation report and supporting documents provided to the TGA with applications for inclusion, review of conformity assessment procedures and post market reviews of medical devices.
- Australian Register of Therapeutic Goods (ARTG)
- The ARTG is the register of information about therapeutic goods for human use that may be imported, supplied in or exported from Australia. All medical devices, including Class I, must be included in the ARTG before supply in Australia. There are limited exceptions to this requirement specified in the legislation.
- Biological characteristics
- relates to use of the materials or substances in contact with the same human tissues or body fluids. Evaluators should consider biological safety (e.g. in compliance to ISO 10993) as well as other aspects necessary for a comprehensive demonstration of equivalence. A justification explaining the situation should be provided for any difference.
- Clinical data
- 28 the safety and/or performance information that is generated from the clinical use of a device. Clinical data are sourced from:
- clinical investigation(s) of the device concerned; or
- clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which substantial equivalence to the device in question can be demonstrated; or
- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which substantial equivalence to the device in question can be demonstrated. (with addition of 'substantial').
- Clinical evaluation
- 28 a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer's Instructions for Use.
Note: In exceptional cases where an instruction for use is not required, the collection, analysis and assessment are conducted taking into account generally recognised modalities of use.
- Clinical evidence
- 34 The clinical data and the clinical evaluation report pertaining to a medical device.
- Competent clinical expert
- Someone with relevant medical qualifications and direct clinical experience in the use of the device or device type in a clinical setting.
For some lower class devices which are not typically used by medical practitioners, another health practitioner who uses the device or similar devices in a clinical setting may be deemed, on a case by case basis, as an appropriate clinical expert who is qualified to critically evaluate and endorse the CER.
- Clinical Evaluation Report (CER)
- 64 A report by an expert in the relevant field outlining the scope and context of the evaluation; the inputs (clinical data); appraisal and analysis stages; and conclusions about the safety and performance of the device. The clinical evaluation report should be signed and dated by the clinical expert.
- Clinical investigation
- 25 systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device.
Note: 'clinical trial' or ' clinical study' are synonymous with ' clinical investigation'.
- Clinical investigation data
- 34 Safety and/or performance information that are generated from the use of a medical device (based on definition above this information is generated in or on one or more human subjects).
- Clinical performance
- 25 behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to the appropriate subject(s).
- Clinical Safety
- 28 freedom from unacceptable clinical risks, when using the device according to the manufacturer's Instructions for Use.
- Clinical use
- 28 use of a medical device in or on living human subjects. NOTE: Includes use of a medical device that does not have direct patient contact.
- Conformity Assessment
- 257 The systematic examination of evidence generated and procedures undertaken by the manufacturer, under requirements established by the Regulatory Authority, to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Principles.
Conformity assessment is the name given to the processes that are used to demonstrate that a device and manufacturing process meet specified requirements. In Australia this means that the manufacturer must be able to demonstrate that both the medical device and the manufacturing processes used to make the device conform to the requirements of the therapeutic goods legislation.
Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with the Essential Principles. It provides objective evidence of the safety, performance, benefits and risks for a specified medical device and also enables regulatory bodies to ensure that products available in Australia conform to the applicable regulatory requirements.
The Conformity Assessment Procedures allow risk based premarket assessment for devices. All manufacturers of all medical devices are required to meet manufacturing standards and all manufacturers, except those manufacturing the lowest risk devices, are audited and are required to have their systems certified. The level of assessment is commensurate with the level and nature of the risks posed by the device to the patient, ranging from manufacturer self-assessment for low risk devices through to full TGA assessment with respect to high-risk devices.
- Conformity assessment certificate
- A certificate to demonstrate that the conformity assessment procedure has been assessed.
- Essential Principles
- The Essential Principles provide the measures for safety and performance and are set out in Schedule 1 of the MD Regulations. For a medical device to be supplied in Australia, it must be demonstrated that the relevant Essential Principles have been met.
- 28 potential source of harm.
- 28 any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.
- Indications for use
- 258 The disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.
- Intended purpose
- Of a kind of medical device, means the purpose which the manufacturer of the device intends to be used, as stated in:
- the information provided with the device; or
- the instructions for use of the device; or
- any advertising material applying to the device
- In-Vitro Diagnostic (IVD)
- A medical device is an IVD if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use. It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures. The definition of an IVD does not encompass products that are intended for general laboratory use that are not manufactured, sold or presented for use specifically as an IVD.
- Kind of medical device
- A single entry in the ARTG may cover a range of products that are of the same kind rather than individual devices. At present, medical devices (with the exception of Class III and Active Implantable Devices (AIMDs) and Class 4 IVDs and Class 4 in-house IVDs) are included as a group in the ARTG under a single entry if they: have the same sponsor; have the same manufacturer; have the same medical device classification; have the same nomenclature system code (GMDN code).
- Refer to section 41BG of the Act.
- Medical device
- A medical device is:
- any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
- diagnosis, prevention, monitoring, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
- investigation, replacement or modification of the anatomy or of a physiological process
- control of conception
- and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means
- any instrument, apparatus, appliance, material or other article specified under subsection (2A)
- any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B)
- an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).
Refer to section 41BD of the Act for remainder of definition.
- Medical device classifications
- Medical devices are classified by the manufacturer according to the intended purpose of the medical device and the degree of risk involved for the patient and user. The device classifications are determined using a set of rules contained in the Regulations that take into account the degree of invasiveness in the human body, the duration and location of use and whether the device relies on a source of energy other than the body or gravity. There are two sets of classification rules; one based on the above and the other based on IVDs as medical devices.
- A previous iteration of the device, within the same lineage of devices, with the same intended purpose and from the same manufacturer, in relation to which a manufacturer is seeking to demonstrate substantial equivalence with that device.
- Post market surveillance:
- Once a device has been included in the ARTG, the sponsor has ongoing responsibilities. These include monitoring and reporting to the TGA adverse events, vigilance reports, complaints, performance issues and regulatory actions in other jurisdictions. Please refer to Sections 22 and 23 of the ARGMD.
- 28 combination of the probability of occurrence of harm and the severity of that harm
- Risk management
- 28 systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk.
- Serious adverse event
- 28 adverse event that
- led to death
- led to serious deterioration in the health of the subject, that either resulted in
- a life-threatening illness or injury, or
- a permanent impairment of a body structure or a body function, or
- in-patient or prolonged hospitalization, or
- medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function
- led to foetal distress, foetal death or a congenital abnormality or birth defect.
Note:Planned hospitalization for a pre-existing condition, or a procedure required by the CIP [Clinical Investigation Plan], without serious deterioration in health, is not considered a serious adverse event.
- Similar marketed device
- An existing marketed device with a similar structure and design and the same intended purpose as the device but not a predicate of the device in relation to which a manufacturer is seeking to demonstrate substantial equivalence. Such a device may not be manufactured by the manufacturer.
- Refer to Section 3 of the Act.
- Substantial equivalence
- Substantial equivalence confirms that the new device is as safe as and performs as well as the predicate or similar marketed device. This determination is based on a review of the new device's intended purpose and technical and biological characteristics.
- Technical characteristics
- 64 these relate to the design, specifications, physicochemical properties including energy intensity, deployment methods, critical performance requirements, principles of operation and conditions of use.
|AAA||Abdominal aortic aneurysm|
|AICD||Active implantable cardiac device|
|AIMD||Active implantable medical device|
|AMSTAR||Assessing the Methodological Quality of Systematic Reviews|
|ARGMD||Australian Regulatory Guidelines for Medical Devices|
|ARTG||Australian Register of Therapeutic Goods|
|ASERNIP-S||Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (Royal Australasian College of Surgeons)|
|AOANJRR||Australian Orthopaedic Association National Joint Replacement Registry|
|BMS||Bare metal stent|
|BSIR||British Society of Interventional Radiology|
|CE||Conformité Européenne (European Conformity)|
|CEBM||Centre for Evidence-Based Medicine|
|CDMSNet||Canadian Medical Devices Sentinel Network|
|CDRH||Center for Devices and Radiological Health [USA]|
|CER||Clinical Evaluation Report|
|CNS||Central Nervous System|
|CONSORT||Consolidated Standards of Reporting Trials|
|CPR||Cumulative Percent Revision|
|CRT||Cardiac Resynchronisation Therapy|
|CSR||Clinical Study Report|
|CTA||Computed tomography angiography|
|D&B||Downs & Black [quality assessment tool]|
|DVT||Deep vein thrombosis|
|EUDAMED||European Databank on Medical Devices|
|FDA||Food and Drug Administration [USA]|
|GCP||Good Clinical Practice|
|GHTF||Global Harmonization Task Force|
|GMDN||Global Medical Device Nomenclature [System]|
|HBD||Harmonisation By Doing|
|HDE||Humanitarian device exemption|
|ICMJE||International Committee of Medical Journal Editors|
|ICD||Implantable Cardioverter Defibrillator|
|ICU||Intensive Care Unit|
|IDE||Investigational Device Exemption|
|IDEAL||Innovation, Development, Exploration, Assessment, Long-term study [Collaboration]|
|IFU||Instructions For Use|
|ILR||Implantable Loop Recorder|
|IMDRF||International Medical Device Regulators Forum|
|IRIS||Medical device Incident Reporting and Investigation Scheme (TGA)|
|ISO||International Standards Organization|
|IVD||In vitro diagnostic|
|KAT||Knee Arthroplasty Trial|
|LOHS||Length of hospital stay|
|MACE||Major adverse cardiac events|
|MAUDE||Manufacturer and User Facility Device Experience database|
|MCID||Minimum clinically important difference|
|MDR||Medical Device Reporting (Program) [USA]|
|MedSun||Medical Device Surveillance Network [USA]|
|MHLW||Ministry of Health, Labour & Welfare [Japan]|
|MHRA||Medicines and Healthcare Products Regulatory Authority [UK]|
|MLHF||Minnesota Living with Heart Failure Questionnaire|
|MPMDB||Marketed Pharmaceutical and Medical Devices Bureau [Canada]|
|MRI||Magnetic Resonance Imaging|
|NB||Notified Body [EU]|
|NCAR||National Competent Authority Report|
|NHMRC||National Health and Medical Research Council|
|NHS||National Health Service [UK]|
|NICE||National Institute for Heath and Care Excellence|
|NOS||Newcastle-Ottawa scale [quality assessment tool]|
|NYHA||New York Heart Association Classification|
|OPC||Objective Performance Criteria|
|PAL||Pharmaceutical Affairs Law [Japan]|
|PCT||Pacing Capture Threshold|
|PDA||Patent Ductus Arteriosus|
|PMA/PMAS||Pre-Market Approval or Pre-Market Approval Supplement [USA]|
|PMCF||Post-Market Clinical Follow-up|
|PMDA||Pharmaceuticals and Medical Devices Agency [Japan]|
|PRISMA||Preferred Reporting Items for Systematic reviews and Meta-Analyses|
|POP-Q||Pelvic Organ Prolapse Quantification System|
|QMS||Quality Management System|
|QOL||Quality Of Life|
|QUADAS||Quality Appraisal of Diagnostic Accuracy Studies|
|RANZCR||Royal Australian and New Zealand College of Radiologists|
|RCT||Randomized controlled trial|
|RIND||Reversible Ischemic Neurological Deficit|
|SAR||Specific Absorption Rate|
|SIGN||Scottish Intercollegiate Guidelines Network|
|SSO||Surgical Site Occurrence|
|STARD||Standards for Reporting of Diagnostic Accuracy|
|STED||Summary Technical Document|
|STROBE||Strengthening the Reporting of Observational Studies in Epidemiology|
|TIA||Transient Ischemic Attack|
|TGA||Therapeutic Goods Administration|
|TLR||Target Lesion Revascularisation|
|TVR||Total Vessel Revascularisation|
|USA||United States of America|
|VARC||Valve Academic Research Consortium|
|VHWG||Ventral Hernia Working Group|
|WHO||World Health Organisation|