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Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

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Attachment H: Glossary and acronyms

Glossary

Term Description
Adverse Event An incident in which harm resulted to a person receiving health care. Such an incident may or may not lead to revision procedures.
AusPAR

An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application.

Before a prescription medicine can be made available in Australia, the company legally responsible for supplying the product must lodge a submission with the TGA. The TGA then evaluates the safety, quality and effectiveness of the product to determine if the benefits to people taking the medicine outweigh the risks.

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.
Application audit assessments

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
    • 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 3: Targeted for completion within 90 days

This RIS proposed introduction of a Level 3 audit, which would consider most of the documentation considered in a Level 1 and Level 2 audits. In addition the TGA would consider:

  • raw clinical data underpinning the conformity assessment report (in addition to the expert clinical report as occurs for the Level 2 audit)
  • the Design Examination report
  • a desk audit of the manufacturer's quality management system.
CE Mark

The CE marking is a mandatory conformity marking for products sold in the European Economic Area. CE marking indicates a product's compliance with EU legislation and enables the free movement of products within the European market.

For medical devices, subject to the type of the device, this requires conformity assessment by a notified body. The notified body will need to assure itself that relevant regulatory requirements have been met before issuing relevant certification. Manufacturers can then place the CE marking on their products to demonstrate compliance with the requirements.

Conformity assessment

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 placed on the market 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 Body

Conformity assessment body means an organisation that conducts conformity assessment activities and includes test facilities and certification bodies. This may include:

  • First-party conformity assessment is where assessment and/or testing are undertaken by the responsible party (e.g. the manufacturer, supplier, or importer);
  • Second-party conformity assessment is assessment and/or testing are undertaken by a person or organization that has a user interest in an object (e.g. the procurer, purchaser or user);
  • Third party conformity assessment is where assessment and/or testing are undertaken by an independent organisation. Third parties such as testing laboratories are qualified as independent in that they do not possess an interest in the person or organisation that provides the medical device being assessed and do not have any user interests in that object.
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 the Regulations. For a medical device to be supplied in Australia, it must be demonstrated that the relevant Essential Principles have been met. The Essential Principles are:

General principles that apply to all devices

  1. Medical devices not to compromise health and safety
  2. Design and construction of medical devices to conform to safety principles
  3. Medical devices to be suitable for intended purpose
  4. Long term safety
  5. Medical devices not to be adversely affected by transport or storage
  6. Benefits of medical devices to outweigh any side effects

Principles about design and construction that apply depending on the kind of device

  1. Chemical, physical and biological properties
  2. Infection and microbial contamination
  3. Construction and environmental properties
  4. Medical devices with a measuring function
  5. Protection against radiation
  6. Medical devices connected to or equipped with an energy source
  7. Information to be provided with medical devices
  8. Clinical evidence

Additional essential principle for IVDs only

  1. Principles applying to IVD medical devices only (this includes 7 principles relating specifically to the safety and performance of IVD medical devices).
European Declaration of Conformity

A certificate of compliance for conformity assessment issued by a European Notified Body. With this Declaration of Conformity, the manufacturer can label the product with the CE Mark, which is required for distribution and sale in the EU.

The EU Declaration of Conformity can also be used to support an application for inclusion of a medical device in the ARTG.

European Competent Authority A competent authority designates notified bodies to conduct conformity assessment procedures specified in the various directives - in the European Union these are the regulators in the Member States, such as the Medicines & Healthcare products Regulatory Agency (MHRA) on the UK.
European Notified Body A notified body, in the European Union, is an organisation that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture. For medical devices, a Notified Body may designate that a medical device conforms to the EU Medical Devices Directive, which defines the standards for medical devices.
Health technology assessment (HTA)

HTA is a range of processes and mechanisms that use scientific evidence to assess the quality, safety, efficacy, effectiveness and cost effectiveness of health services. HTA is commonly applied to pharmaceuticals (including vaccines), diagnostic tests, medical devices, surgically implanted prostheses, medical procedures and public health interventions. The key questions that HTA typically aims to answer for each new health technology, in comparison to alternative interventions, relate to safety, health outcomes, and cost effectiveness.

Effective assessment of health technologies include evaluating the comparative harms and benefits, using clinical evidence of patient safety, efficacy and clinical effectiveness, and understanding the cause, origin and prevalence of disease and knowledge of best practice treatment pathways.

A key HTA process for medical devices is the Prostheses List, which sets the reimbursements private health insurers are required to pay for a range of prostheses that are provided as part of an episode of hospital treatment (or hospital substitute treatment) where a Medicare benefit is payable for the associated professional service (surgery).

In-Vitro Diagnostic device (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 A manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations. Refer to section 41BG of the Act for remainder of definition.
Manufacturer's evidence This is the conformity assessment evidence that demonstrates that a manufacturer has appropriate manufacturing processes to make the devices. Once the manufacturer’s evidence is accepted by the TGA the sponsor can make an application to include their device in the ARTG. Acceptable manufacturer's evidence for most medical devices includes equivalent conformity assessment certification issued under the provisions of the European Medical Devices Directives, commonly referred to as CE certificates.
Medical device

A medical device is:

(a) 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

(aa) any instrument, apparatus, appliance, material or other article specified under subsection (2A)

(ab) 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)

(b) 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 whether an IVD medical device.

Medical devices (other than IVD medical devices):
Class Risk Examples
Class 1 Low risk Surgical retractors, tongue depressors

Class I - supplied sterile

Class I - incorporating a measuring function

Low-medium risk Sterile bandages, drainage bags
Class IIa Hypodermic needles, suction unit
Class IIb Medium-high risk Lung ventilator, hip, knee and shoulder joint implants
Class III High risk Heart valves
AIMD (Active Implantable Medical Devices) Implantable defibrillator
IVD medical devices:
Class Risk Examples
Class 1 IVD No public health risk or low personal risk

Enzyme immunoassay analyser.

Ready to use microbiological culture media.

Class 2 IVD Low public health risk or moderate personal risk

Pregnancy self-testing kit.

Liver function tests.

Class 3 IVD Moderate public health risk or high personal risk

Test to detect the presence or exposure to a sexually transmitted agent such as C. trachomatis or N. gonorrhoea.

System for self-monitoring of blood glucose.

Class 4 IVD High public health risk

Assay intended for the clinical diagnosis of infection by HIV 1 & 2.

Assay intended for screening blood donations for Hepatitis C virus.

National Joint Replacement Registry (NJRR)

The NJRR is managed by the Australian Orthopaedic Association (AOA)68. Its purpose is to define, improve and maintain the quality of care of individuals receiving joint replacement surgery. The NJRR collects data following each surgical procedure that enables outcomes to be determined on the basis of patient characteristics, prosthesis type and features, method of prosthesis fixation and surgical technique used. The principal measure of outcome is revision surgery and provides an unambiguous measure of the need for further intervention. This information is then used to inform health care professionals, governments, and consumers.

68 From the National Joint Replacement Registry website on 6 February 2012 at <http://www.dmac.adelaide.edu.au/aoanjrr/about.jsp?...

Quality Management System (QMS) The International Standards Organisation (ISO) describes a quality management system as a set of interrelated or interacting processes and interfaces, whose purpose is to achieve defined objectives, within the constraints of established policy. The system is to direct and control a group of people and facilities, with an arrangement of responsibilities, authorities and relationships. Such controls and arrangements are necessary to ensure that outputs of the system have a set of predetermined inherent and distinguishing features that fulfil a need or expectation that is stated generally, implied or obligatory.
Revision procedures The need to undergo further corrective surgery.
Sponsor

Under Section 7 of the Act a Sponsor, in relation to therapeutic goods, means:

  1. a person who exports, or arranges the exportation of, the goods from Australia; or
  2. a person who imports, or arranges the importation of, the goods into Australia; or
  3. a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere); but does not include a person who:
  4. exports, imports or manufactures the goods; or
  5. arranges the exportation, importation or manufacture of the goods; on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

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Acronyms

Acronym Meaning
AIMD Active Implantable Medical Devices
AOA Australian Orthopaedic Association
ARTG Australian Register of Therapeutic Goods
ASR A series of DePuy hip replacement products
CAB Conformity Assessment Body
CHF Consumers’ Health Forum of Australia
CRIS Cost Recovery Impact Statement
DoFD Department of Finance and Deregulation
DoHA Department of Health and Ageing
eBS eBusiness Services
EC European Commission
EU European Union
GHTF Global Harmonization Task Force
GMDN Global Medical Device Nomenclature
HTA Review Review of Health Technology Assessment in Australia
IMDRF International Medical Device Regulators Forum
ISO International Standards Organisation
IVD In-Vitro Diagnostic device
MTAA Medical Technology Association of Australia
NJRR National Joint Replacement Registry
OBPR Office of Best Practice Regulation (Department of Finance and Deregulation)
PIP Poly Implant Prothèse (French breast implant manufacturer)
QMS Quality Management System
RIS Regulation Impact Statement
TGA Therapeutic Goods Administration

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