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Clinical evidence guidelines: Medical devices

24 February 2017

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Appendix 2: Glossary and abbreviations

Glossary

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.
Assessor
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.
Hazard
28 potential source of harm.
Incident
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).
Manufacturer
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
  1. 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)
  2. 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)
  3. 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.
Predicate
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.
Risk
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
  1. led to death
  2. led to serious deterioration in the health of the subject, that either resulted in
    1. a life-threatening illness or injury, or
    2. a permanent impairment of a body structure or a body function, or
    3. in-patient or prolonged hospitalization, or
    4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function
  3. 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.
Sponsor
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.

Abbreviations

Abbreviation Meaning
AAA Abdominal aortic aneurysm
AE Adverse event
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]
DES Drug-eluting stent
DVT Deep vein thrombosis
EU European Union
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
MA Meta-analysis
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]
MI Myocardial infarction
MLHF Minnesota Living with Heart Failure Questionnaire
MPMDB Marketed Pharmaceutical and Medical Devices Bureau [Canada]
MR Magnetic Resonance
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]
NR Not Reported
NYHA New York Heart Association Classification
OPC Objective Performance Criteria
PAL Pharmaceutical Affairs Law [Japan]
PCT Pacing Capture Threshold
PDA Patent Ductus Arteriosus
PE Pulmonary Embolus
PMA/PMAS Pre-Market Approval or Pre-Market Approval Supplement [USA]
PMCF Post-Market Clinical Follow-up
PMDA Pharmaceuticals and Medical Devices Agency [Japan]
PPM Permanent Pacemaker
PRISMA Preferred Reporting Items for Systematic reviews and Meta-Analyses
PMS Post-market Surveillance
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
RF Radiofrequency
RIND Reversible Ischemic Neurological Deficit
RSA Radiostereometric analysis
SAR Specific Absorption Rate
SD Standard Deviation
SIGN Scottish Intercollegiate Guidelines Network
SSO Surgical Site Occurrence
SR Systematic Review
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
UK United Kingdom
USA United States of America
VARC Valve Academic Research Consortium
VHWG Ventral Hernia Working Group
VTE Venous Thromboembolism
WHO World Health Organisation

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