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HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS

Your regular update for technical and industry information

TÜV SÜD at Medica  

TÜV SÜD’s experts on medical devices in many countries will attend Medica in Düsseldorf from 14 to 17 November 2016. TÜV SÜD’s stand at the exhibition (Hall 10, Stand C12) will focus on the new Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Replacing the laws previously in place, these new regulations will impose stricter requirements for medical device manufacturers in many respects. At the TÜV SÜD stand, medical device manufacturers will also be able to find out more about efficient ways to unlock global markets for their products.

Although the new medical device regulations have not yet been finally passed, some new terms are already clear. Manufacturers will be shouldering greater responsibility, and requirements for documentation and assessment will be stricter. The new laws will also include changes in product classification. TÜV SÜD’s experts will provide information on forthcoming new requirements to enable medical device manufacturers to best prepare themselves for the introduction of the regulations.

International Expertise  

At the trade show, TÜV SÜD’s experts will provide the latest information on changes in approval procedures as well as information and experience from global projects. The experts at the company’s Medical and Health Services (MHS) unit of the Product Service division are represented at over 30 locations around the world, and thus have in-depth familiarity with current requirements on the various target markets. Manufacturers can benefit from the expertise of these medical device specialists as well as from TÜV SÜD’s extensive range of international accreditations, which simplifies access procedures for many international target markets. For manufacturers seeking the most efficient way to launch their products on multiple markets such as Australia, Brazil, Japan, Canada and the USA, interesting topics may include audits under the Medical Device Single Audit Program (MDSAP).

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) - PILOT PROJECT IN ITS FINAL PHASE

The Medical Device Single Audit Program (MDSAP) is a project set up by the International Medical Device Regulators Forum (IMDRF). MDSAP allows for a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory jurisdictions. A medical device manufacturer can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. Although the pilot phase is scheduled to finish at the end of 2016, the programme is likely to continue beyond this point. TÜV SÜD was one of the first audit organisations to gain authorisation to conduct MDSAP audits, and has done so since 2014. During that time, the company has amassed a wealth of experience to benefit its customers.

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