CE2012 Medical Device Regulatory Revision Austin Court, Birmingham 20th September 2012 Sponsored by

THE REGULATION OF MEDICAL DEVICES - GLOBAL TRENDS Alan Kent CE2012 - 20th September 2012

THEMES Why regulate? The Global Harmonization Task Force (GHTF). The International Medical Device Regulators Forum (IMDRF). Developing regulations. EU, USA, Japan, Canada update. Challenges for industry.

WHY REGULATE? To safeguard public health. As an indicator of improved prosperity. Prevent ‘dumping’ of non-conforming devices. Reduce the uncontrolled importation of products of dubious benefit or provenance. Encourage the development of a local medical devices industry. In the EU …… to enable the single market.

MATURE REGULATIONS EU / EFTA USA Japan Canada Australia GHTF FOUNDING MEMBERS

EMERGING REGULATIONS Hong Kong Saudi Arabia Singapore Brazil South Africa Etc. MEMBERS OF AHWP

GHTF FORCE STRUCTURE Conceived in September 1992. Purpose: to encourage convergence of existing medical device regulations, and publish regulatory guidance documents for use by ‘new-entrants’. A self-funding organisation with equal participation from regulators and industry of the Founding Member jurisdictions (eventually included AHWP). Five Study Groups to undertake the work under the direction of a Steering Committee. SGs meet face-to-face about 3 times per annum.

GHTF OBJECTIVES Improve public health, globally. Remove unnecessary regulatory differences and duplicative controls to simplify trade and reduce regulatory costs. Encourage the introduction of beneficial new technology. Encourage RAs to exchange information on adverse events / incidents. continued …..

GHTF OBJECTIVES Share the experience of GHTF Founding Members with other countries introducing or modifying regulations. Secure the universal recognition of regulatory decisions, certificates and inspections. Rotating Secretariat with an informative website @ www.ghtf.org.

OVERARCHING DOCUMENTS GHTF Medical Device Regulatory Model. Definition and Glossary of Terms Used in GHTF Documents. Unique Device Identification (UDI) System for Medical Devices. GHTF Retrospective Assessment - Key Findings and Recommendations (January 2008).

STUDY GROUP THEMES SG5: clinical safety and performance. SG1: premarket procedures. SG2: reporting adverse incidents and post-market surveillance. SG3: quality systems for manufacturers and inspectors of medical devices. SG4: quality system auditing practices. SG5: clinical safety and performance.

SO WHY CHANGE? Major items of work are ‘completed’. Remaining issues are ‘difficult to harmonize’ e.g. combination products / devices incorporating viable animal or human tissues / nanomaterials. Pressure on RA budgets. Why should a government devote resource to global rather than national priorities? continued …..

REASONS FOR CHANGE Public / media / political criticisms of the effectiveness of Founding Member’s regulations (e.g. breast implants / orthopaedic implants etc.). RAs seen as being too close to the regulated industry. While the ‘legal manufacturer’ is located in Founding Member jurisdictions, most medical devices are made in China, Mexico, Brazil and the developing World. This affects the regulatory task.

THE GHTF IS DEAD ……. LONG LIVE THE IMDRF International Medical Device Regulators Forum first met in May 2011 (Australia Chair). The forum is for RAs - Industry is not a member. Industry invited to participate in some Working Groups but otherwise are limited to providing comments on draft documents. China, Brazil, India, Russia have been invited to join (AHWP?). GHTF documents will be maintained – HOW?.

FIRST 5 IMDRF WORK ITEMS Improvement of GHTF National Competent Authority Reporting (NCAR) system and exchange of PMS information. RA only WG - I. Demade (EU Commission) to lead. Roadmap for implementation of UDI system. Joint WG - L. Selles (EU Commission) to lead. Report by Dec. 2012. Single QMS audit programme accreditation requirements. Closed WG - K. Trautmann (US FDA) to lead. Initial focus on guidance on qualifications/certification/accreditation of auditors for regulatory purposes. Report 12-18 months continued …..

FIRST 5 WORK ITEMS List of standards recognised by IMDRF regulators as basis for demonstrating conformity. RA only WG - M. Neumann (Germany BfArM). Report end-2013. Regulated Product Submission (RPS) in electronic format standard. Part open / part closed WG - M. Ward (Health Canada). Pre- and post-marketing submissions; assess fitness for purpose for medical devices; start with ‘table of contents’ based on GHTF STED.

The subject of this Conference. EU UPDATE The subject of this Conference. continued …..

USA UPDATE Proposed User Fee 5-year Renewal request is with US Congress. Ten potential bills impacting FDA/Medical Devices under discussion by US Congress. FDA continues to address the pre-amendments, Class III devices 515(i) calls for information that include two classification involving metal-on-metal total hip replacements (cemented and un-cemented versions). continued …..

USA UPDATE FDA continues to assess the safety and effectiveness of urogynaecologic surgical mesh devices, through review and analysis of published literature, adverse event reports, and post-approval surveillance studies. FDA is considering the recommendation that urogynaecologic surgical mesh used for trans-vaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

CANADA UPDATE A document on what information should appear in a QMS audit report has been published (based on SG4 guidance). Will now accept premarket submissions in the STED format for medical devices other than IVDS. Working on guidance for reprocessing of single-use devices, and on refurbishing. About to publish a notice on the transition to the revised version of IEC 601 standard (i.e. Edition 3), and its collateral standards.

JAPAN UPDATE Proposed revision of Pharmaceutical Affairs Law to take account of the unique characteristics of medical devices was published in January 2012. Due to on-going reform to social security system etc., submission of legislation related to the revision of Pharmaceutical Affairs Law is likely to be deferred to the next session of the National Diet of Japan in the latter part of this year.

CHALLENGES FOR INDUSTRY Keep abreast of changes to national medical device regulations – and a host of others. Influencing the IMDRF – especially SMEs. Promote the benefits of medical devices to MEPs, MPs, the public, and the media - thereby increasing confidence and trust in the industry. Persuading senior management to support its regulatory and QMS departments and maintain a robust and continually improving QMS. continued …..

CHALLENGES FOR INDUSTRY Building bridges to RAs in target markets – all with the active participation of senior management. Strengthen product liability defence strategies since many countries are becoming more litigious. Adopt a life-cycle management approach to the design and support of devices, including a strategy for addressing disposal and environmental issues. Regulations are placing an increasing emphasis on post- marketing activities/controls.

THANK YOU

CE2012 Medical Device Regulatory Revision Austin Court, Birmingham 20th September 2012 Sponsored by