IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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EDITOR'S PAGE Don't Fear New EU IVD Regulation The proposed European medical device and IVD regu- lations, which were published by the European Commission on September 26, 2012, were at the center of many conversa- tions at MedTech Forum 2012, which was held in Brussels in mid-October. During a break in meetings, I was able to spend a few minutes with Jürgen Schulze, president of the European Diagnostic Manufacturers Association (EDMA), and ask how the new regulations might affect the IVD industry. "I'm not a regulatory expert," cautioned Schulze, before noting his satisfaction that the regulation embraces harmoniza- tion by following the risk-based classifi cation set forth by the Global Harmonization Task Force. "Th at gives me hope," he noted, although he wonders if the needs of small to medium- size enterprises (SMEs) have been adequately taken into consideration. (In addition to leading the association, Schulze is president, EMEA, of diagnostics company Sysmex.) Large companies have been working toward this goal and will fi nd it relatively easy to adapt, he said. SMEs may fi nd compliance more challenging, he added, especially as concerns Notifi ed Bodies (NBs), "which many of the smaller companies have not had to deal with." Th e position of NBs vis-à-vis manufacturers has been sig- nifi cantly strengthened in both regulations. In particular, they will be empowered to carry out unannounced factory inspec- WWW.IVDTECHNOLOGY.COM tions and to conduct physical or laboratory tests on devices. Th e proposal also requires rotation of NB personnel involved in the assessment of IVDs "to ensure continuous objectivity and neutrality." Th e full document can be downloaded at http:// ec.europa.eu/health/medical-devices/fi les/revision_docs/pro- posal_2012_542_en.pdf. Schulze referred me to EDMA regulatory aff airs director Jesús Rueda Rodriguez for insights on a new scrutiny procedure that has been written into both regulations. While the medi- cal device industry is largely opposed because it may lengthen approval times, its impact on the IVD community is negligible, says Rodriguez. "Th is scrutiny procedure has been designed for high-risk novel devices," says Rodriguez. "Since all high-risk IVDs are already covered by common technical specifi cations (CTS), the scrutiny procedure becomes trivial." Th e proposals are now with the European Parliament. At the meeting, European Commissioner for Health John Dalli solemnly predicted that the regulations would become law before the parliamentary elections in June 2014. Of course, Dalli has since resigned for alleged knowledge of infl uence peddling, so it's debatable how much weight his pronounce- ment now carries. IVDTECHNOLOGY EDITORIAL ADVISORY BOARD Richard M. Bauer, PhD Staff Scientist Attila T. Lorincz, PhD Siemens Medical Solutions Diagnostics Steven R. Binder Director, Technology Development Bio-Rad Laboratories Avis T. Danishefsky, PhD Scientifi c Reviewer Offi ce of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA Glen Paul Freiberg, RAC President RCQ Consulting Mary Lou Gantzer, PhD Professor of Molecular Epidemiology Wolfson Institute, University of London Leif E. Olsen Director of Regulatory Sciences Hogan & Hartson David T. Pearman Sales Manager Response Biomedical Corp. Donald M. Powers, PhD President and Principal Consultant Powers Consulting Services Vice President of Clinical Studies Siemens Healthcare Diagnostics Jeffrey N. Gibbs, JD Director Hyman, Phelps & McNamara Craig M. Jackson, PhD President and Principal Scientist HemoSaga Diagnostics Corp. Daniel P. Kolk, PhD Director Product Development Gen-Probe Inc. Richard T. Root (retired) Formerly Roche Diagnostics Patricia B. Shrader, JD Becton, Dickinson and Co Katie M. Smith, PhD Principal Katie Smith Consulting Vana L. Smith, PhD 8 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 Norbert Sparrow norbert.sparrow@ubm.com Joanne M. Stephenson Head of Strategic Marketing Innovative Biosensors Inc. Susan L. Taylor Marketing Manager, Systems LipoScience Inc. Thomas M. Tsakeris President Partner Rational Systems LLC Doris-Ann Williams Vice President, Regulatory, Public Policy, and Communications Devices and Diagnostics Consulting Group Mark S. Vreeke, PhD Director-General British In Vitro Diagnostics Association Emily S. Winn-Deen, PhD Vice President, Strategic Planning and Business Development Cepheid Jack J. Zakowski, PhD Beckman Coulter Inc. Quality Assurance Manager, Global Customer Communication Systems Abbott Laboratories ivdtechnology.com Director, Scientifi c Aff airs and Professional Relations

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