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Regulation impact statement: Changes to premarket assessment requirements for medical devices
A paper, Changes to premarket assessment requirements for medical devices2, was released by the TGA on 14 January 2013, with consultation closing on 15 March 2013. The proposals outlined in that paper built on previous consultation dating back to 2008, and outlined three proposed regulatory reforms for premarket assessment of higher risk medical devices:
- Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion, through:
- Targeting of mandatory audits for a wider range of high risk medical devices (but not in vitro diagnostic devices (IVDs))
- Increased assessment of additional evidence of conformity (but not IVDs)
- Proposal B: Publication of medical device regulatory decisions (including IVDs)
- Proposal C: Abolition of the requirement for TGA conformity assessment for Australian manufacturers of lower Class medical devices (including IVDs).
Submissions to the January to March 2013 consultation were considered and the proposals revised. A further paper, Regulation Impact Statement (RIS) exposure draft: Changes to premarket assessment requirements for medical devices3, was released by the TGA on 10 May 2013, with consultation closing on 3 June 2013.
The RIS exposure draft outlined three options for regulatory reform of premarket assessment requirements for medical devices:
- Option 1: No immediate action.
- Option 2: Changes to premarket assessment of medical devices through
- increased scrutiny of conformity assessment for higher risk medical devices as part of mandatory application audits prior to ARTG inclusion
This proposal was modified based on submissions to the January to March 2013 consultation, with the extension of mandatory audit arrangements narrowed to those devices of most concern. It had previously been proposed to audit all Class IIb implantable and long term surgically invasive devices
- publication of information about TGA regulatory decisions (including IVDs)
This proposal was modified based on submissions to the January to March 2013 consultation, to provide for a summary of the assessment of a medical device and the considerations that led the TGA to approve or not approve a medical device application for conformity assessment or inclusion in the ARTG, while it had previously been proposed to publish only the decision
- abolition of requirement for TGA conformity assessment for Australian manufacturers (excluding manufacturers of Class 4 IVDs)4
This proposal was modified based on submissions to the January to March 2013 consultation by broadening it to include all Australian manufacturers of all medical devices except Class 4 IVDs. It had previously been proposed to apply only to lower class devices.
- increased scrutiny of conformity assessment for higher risk medical devices as part of mandatory application audits prior to ARTG inclusion
- Option 3: Expand TGA mandatory conformity assessment for AIMD and Class III implantable medical devices and allow third party conformity assessment for all medical devices except Class 4 IVDs.
Submissions to the May to June 2013 consultation on the RIS exposure draft have now also been considered in finalising this RIS. This document has been revised to clearly articulate the issue and case for increasing premarket assessment of devices, as feedback received on the exposure draft indicated some confusion about the key drivers for reform. A further revision has also been made to Option 2B in this document. It is now proposed that decisions published under Option 2B would continue to include all positive decisions but limit publication of negative decisions to only those where the rejection relates to issues involving the medical device’s safety and / or efficacy, to ensure transparency is increased around negative decisions which have implications for public health.
A summary of how the proposals have evolved through consultations since 2010 is included at Attachment A: Previous and current reform proposals.
As outlined above, this RIS is based on feedback received as part of the entirety of consultations on this topic. This document aims to ensure public health and safety is protected through a balanced, targeted approach based on risk whilst minimising duplication of effort and cost, and taking into account the broader environment.
Under the Therapeutic Goods Act 1989 medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) prior to supply in Australia (unless exempt from that requirement). An outline of the current regulatory arrangements for medical devices is included at Attachment B: Regulation of medical devices in Australia. The TGA's current regulatory framework is based on the model recommended by the Global Harmonisation Task Force (GHTF)5 and became fully operational in Australia in October 2007. The intent of the GHTF was to achieve international alignment of regulatory requirements for medical devices to ensure, amongst other things, that devices available to the public are of acceptable quality, safety, and perform as intended.
Conformity assessment is the key mechanism for assuring that a medical device is safe and performs as intended through meeting the Essential Principles. The requirements for conformity assessment become more stringent as the risks associated with the medical device increases.
A conformity assessment certificate is issued by a conformity assessment body (where the medical device is safe, performs as intended and is of acceptable quality). Once a conformity assessment certificate is issued, an application to include the medical device in the ARTG may be made. The TGA is currently the only conformity assessment body for the purposes of administering the medical device regulatory framework in Australia.
The degree of rigour of the assessment conducted by the TGA at the point of application for ARTG inclusion depends on the risk classification of the device and the source of the conformity assessment certification (see Attachment B: Regulation of medical devices in Australia for details). The TGA may approve the inclusion of a device in the ARTG based solely on the application received, or may audit the application through a desk top review of information such as the labelling, instructions for use and the clinical evidence for the device. The scope of the audit will depend largely on the issues identified by the TGA as requiring further scrutiny. In most cases, high risk devices (Class III) are subject to mandatory application audits where the conformity assessment body is a European notified body.
The TGA issues conformity assessment certification under the Australian regulatory framework. European notified bodies also issue conformity assessment certification under the European regulatory framework6. As medical devices are assessed based on Essential Principles relating to safety and performance (rather than a prescriptive framework), and given the similarities between the Australian and European regulatory frameworks (both being based on the GHTF model), conformity assessment certificates issued by European notified bodies are generally accepted as evidence of conformity assessment sufficient for inclusion in the ARTG.
The above practice recognises that conformity assessment is an intensive and potentially expensive process and that unnecessary duplication of this work would increase the costs of many medical devices for consumers and create disincentives to supply products in Australia’s small medical devices market (around 2 per cent of the global market). This compares to the USA, which is the world’s largest medical device market with around 40 per cent7 of the estimated $300 billion in global medical device revenue8.
In practice, certification issued by European notified bodies is used for more than 97 per cent of applications for inclusion of medical devices (excluding IVDs9) in the ARTG requiring independent conformity assessment certification. Unless the application for inclusion in the ARTG is audited, European conformity assessment certification is generally accepted, relying on the accreditation of the notified bodies by European authorities.
Where an application audit is undertaken, the TGA may analyse in detail the conformity assessment procedure undertaken by the European notified body. However, the TGA may only charge a fee to undertake mandatory audits. The TGA is unable to charge a fee for audits undertaken at its discretion.
There are some significant international developments that will impact on Australia's regulatory framework and therefore need to be considered in the context of the reforms proposals outlined in this RIS. These are discussed below.
Performance of notified bodies and proposed European reforms
There is significant and increasing international concern over the performance of some European notified bodies and the level of evidence reviewed prior to issuing the certification which enables the device to be approved for marketing in the European Union (EU). These issues are highlighted in a series of articles published in the British Medical Journal about medical device regulation.10
Some of the key issues highlighted in the articles are summarised below:
- Patient health and safety should underpin the basis for any marketing approval granted, not financial or trade facilitation considerations. Given notified bodies are private commercial entities that are paid by their clients to issue conformity assessment certificates, there is a widespread perception that this conflict of interest means the European regulatory system for medical devices is flawed and not focussed on patient health and safety.
- There is little transparency about the basis of marketing approval issued by European notified bodies.
- The level of evidence to support the marketing approval of many higher risk devices is insufficient to allow safe widespread use.
A report produced by the United States Food and Drug Administration (FDA) in May 201211 supports the above articles. In particular, the report states:
US law requires sufficient valid scientific evidence in humans that high-risk devices are both safe and effective - that is, that they provide real benefit to patients in actual use, and that their risks are well defined. In contrast, EU approval is conducted by private companies and based on more limited evidence, often without significant studies in humans, that high risk devices are safe and that they are mechanically fit to perform the job they are labelled to do. There is no actual requirement in the EU that a high-risk device provide an actual treatment benefit to patients.12
The report also states that:
Because of the EU's lower approval standard and degree of oversight, high-risk devices are more often approved first in the EU than in the US. The lack of valid evidence of effectiveness has several negative effects on patients, however. As shown in this report, the EU’s reliance on limited testing, generally without significant testing in humans, can fail to predict dangerous risks and ineffective treatment in actual use. As a result, approval of devices without a valid demonstration of effectiveness has permitted the marketing of products in the EU that turned out to cause severe harm to patients, either because the testing was inadequate to reveal the device’s risk or because use of an ineffective device denied patients access to effective treatments for serious diseases. In addition, the lack of valid data on effectiveness has caused some of the biggest EU countries to delay reimbursement for some approved high-risk devices until a second, sometimes lengthy, cost-effectiveness review is completed. In those cases, EU approval of a device does not necessarily mean that it is available to patients there.
The EU system for approving devices has now also come under criticism from the European medical community because of the number of devices that have turned out to be dangerous or ineffective. The medical community has also expressed dissatisfaction with the inconsistent review standards of the private bodies that approve devices in the EU and the secrecy of the approval process there.13
On 26 September 2012, the EU announced a package of reforms14 to provide for more stringent regulation of medical devices with the EU to ensure a high level of protection of human health and safety.
The EU intends to reform the operation of notified bodies to ensure the legal requirements concerning the premarket evaluation of medical devices are applied and implemented effectively in all member states, particularly that notified bodies follow the same high standards and criteria when they undertake conformity assessments. This is because of reported variations in the quality and depth of conformity assessment performed by notified bodies which could lead to variations in the level of protection of patient and user safety. The specific EU reform proposals include:
- Stronger supervision of European notified bodies by national authorities in addition to joint assessments to be carried out by other EU member states and the European Commission
- Rotation of notified body personnel involved in the assessment of medical devices
- Tightening and streamlining conformity assessment procedures
- Establishing a new expert committee to review individual conformity assessments
- Increasing the powers of notified bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections
- Publication by manufacturers of a safety and performance summary with supporting clinical data
- Stricter requirements for clinical evidence to support assessments of medical devices.
Given the reliance by Australia on conformity assessment certification issued by European notified bodies, the identified issues with European notified bodies and the proposed European reforms, these developments are of significant interest. However, it will take a number of years before the details and full scope of EU reform proposals will be confirmed as these will be the subject of on-going negotiation , and it may be 2020 before the proposed reforms take effect in Europe.
A summary of the EU issues and proposed changes is included at Attachment C: Proposed changes to European Union Medical Devices Directive.
International Medical Device Regulators' Forum (IMDRF) activities and European reforms
Australia has made a commitment to support international efforts to harmonise international regulatory requirements for medical devices both through participation in the GHTF and adoption of the GHTF recommendations in setting up its current regulatory framework. Australia is continuing this commitment as a member of the IMDRF16. There are a large number of projects underway that should assist in achieving a consistent regulatory approach across jurisdictions and increase confidence in assessments conducted by conformity assessment bodies. These projects are also likely to result in further refinements to the medical devices regulatory framework in the future and may reduce costs to industry over the longer term through international consistency of approach among regulators.
Mutual Recognition Agreement (MRA) with the EU and confidence building
Australia has an MRA with the EU for conformity assessment processes which allows the TGA to issue conformity assessment certificates under European legislation, and European notified bodies to issue conformity assessment certificates under Australian legislation.
Changes to the provisions of the MRA came into force on 1 January 201317 and specify that MRA certificates will no longer be accepted for Active Implantable Medical Devices (AIMD) and Class III medical devices. MRA certificates could be accepted again after confidence building has occurred to ensure that appropriate assessment of medical devices has been conducted by conformity assessment bodies (either TGA or the European notified body).
Confidence building is a process for both EU and Australian regulators to gain assurance on the technical competence of each other's conformity assessment bodies (CABs) to certify products for compliance with the regulatory requirements of the other jurisdiction, largely eliminating the need for duplicative testing or re-certification when the goods are traded. Discussions under the MRA have commenced with a view to progressing these activities over 2013 and 2014. However, at the time of writing, no formal agreement has been reached with the EU on what will comprise confidence building and how it will occur.
Australian New Zealand Therapeutic Products Agency (ANZTPA)
In June 2011 the Australian and New Zealand Governments announced their agreement to proceed with the establishment of a joint scheme for regulation of therapeutic products, including medical devices. The new joint agency, ANZTPA,18 is expected to be operational by 2016.
New Zealand's current medical device regulation is focused primarily on postmarket surveillance. As a result, it is likely that Australian premarket regulatory requirements will be the basis for new ANZTPA arrangements. Feedback on the reforms proposed in this RIS has been sought from the New Zealand medical device industry, and submissions were received in both March and June 2013 from the Medical Technology Association of New Zealand (MTANZ). Feedback indicates concern that the post market focus of current New Zealand arrangements may make further increases in premarket scrutiny, including transitional arrangements, more difficult for New Zealand sponsors and manufacturers.
Previous reviews and inquiries
In February 2010 the Australian Government accepted most of the recommendations from the Review of Health Technology Assessment in Australia (December 2009) (known as the HTA Review)19.
The HTA review noted that there was concern from some stakeholders and/or evidence that the premarket assessment process was not rigorous enough in some instances in relation to evidence of safety and performance of medical devices. Orthopaedic joint implants were identified by stakeholders as examples of devices where safety and performance were not adequately evaluated prior to inclusion in the ARTG, resulting in risks to consumers and cost to taxpayers. This was based on long term performance data that indicated that some orthopaedic implants were associated with a higher failure rate than others. It was argued that this risk could be addressed, to some extent, by improved premarket evaluation.
Additionally, the HTA review identified that the requirement for Australian manufacturers to exclusively use the TGA to obtain conformity assessment certification was problematic.
The HTA review therefore recommended that the TGA respond to issues identified in consultations in 2008-09 regarding third party conformity assessment and increase the rigour of regulatory assessment of higher risk medical devices. These elements of the HTA recommendations were accepted by Government, and further consultation undertaken in late 2010.
In 2011, there was a Senate Inquiry into the regulation of medical devices following the failure of the ASR hip implants. One of the recommendations from that Inquiry was that the HTA review recommendation relating to increased premarket assessment of higher risk medical devices be fully implemented. The Government also agreed to this recommendation.
As part of this Inquiry, the Government also agreed that the TGA consult with stakeholders on the recommendation to increase the level of evaluation for higher risk medical devices and on the proposal to allow Australian manufacturers to obtain conformity assessment certification from organisations other than the TGA.
Based on all the above, TGA is proposing to refine its risk-based approach to ensure that, where there is a high level of risk to a patient associated with the use of a device, additional scrutiny is applied prior to approving that device for marketing in Australia rather than relying on postmarket mechanisms alone.
A summary of the recommendations from previous report and consultations is included at Attachment D: Previous reports and consultations.
- Class 4 IVDs are not included at this stage due to the lower level of regulatory oversight of these devices in Europe, and the broad public health implications if these devices fail - outlined further below in the discussion of Option 2 - Changes to premarket assessment of medical devices.
- Under the Mutual Recognition Agreement (MRA) between Australia and the European Union some European notified bodies are authorised in specified circumstances to issue conformity assessment certificates under the Australian regulatory framework, and such MRA conformity assessment certificates are treated in the same manner as TGA conformity assessment certificates.
- Espicom Business Intelligence, The Medical Device Market: USA, 2013
- Unlike Australia, Europe does not yet have the same regulatory requirements for IVDs to align with the GHTF model. However, it is proposing to implement the GHTF model as part of its recently announced reform program.
- For example: Deborah Cohen, Out of Joint, 21 May 2011, BMJ 2011;342:d2905; Deborah Cohen, EU approval system leaves door open for dangerous Devices, 24 October 2012, BMJ 2012;345:e7173; Philipp Storz-Pfennig et al, Trials are needed before new devices are used in routine practice in Europe, 11 May 2013, BMJ 2013;346:f1646
- Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US, May 2012, document produced by the FDA and available online at: <http://www.elsevierbi.com/~/media/Supporting%20Documents/The%20Gray%20Sheet/38/20/FDA_EU_Devices_Report.pdf>
- Ibid, p 3.
- Ibid, p 5-6.
- The proposals have been submitted to the European Parliament and the Council of the European Union. In order to become binding Union law, the Parliament and Council need to adopt the texts by ordinary legislative procedure.