The continually changing European Union regulations governing medical devices were the focus of two days of workshops offered by leading industry experts at the inaugural Medical Device & Technology Test Expo held in Cologne, Germany, this week.
Dr Rosy Eloy, Medical Director for Europe of BIOMATECH – NAMSA, focused on the changes to the new 2007/47 Medical Device Directive in her workshop.
As of March 2010, medical device manufacturers are required to beef up the evaluations of the safety and performance of their products. Dr Eloy underscored the new provision that manufacturers produce clinical data on the safety and performance of all medical devices, regardless of the classification of the device. Also new is the requirement that manufacturers back up their data with an analysis of the related risks and benefits.
Looking ahead, two workshops focused on how manufacturers of electronic medical devices can comply with changes to the regulations due to come into force from June 2012 in Europe and in Canada, and from June 2013 in the United States.
A team from Underwriters Laboratories (UL) led an interactive workshop on how manufacturers can get their products certified according to the 3rd edition of the IEC 60601-1, the internationally harmonized standard for the safety of electrical medical devices.
Dr Terenzio Facchinetti, UL’s Business Development Manager for Life & Health Sciences, said manufacturers could avoid the frustrations and cost of redesign of products if they consider the regulatory and certification requirements at the early stage of product development.
In a separate workshop, two experts from DEKRA Certification B.V. (formerly KEMA Quality), gave a practical demonstration on how manufacturers must incorporate risk analysis—a new provision in the law—into the safety testing of their products.
The workshops were a key feature of the Medical Device & Technology Test Expo 2011, the world’s first-ever business to business trade fair to focus exclusively on testing at each stage of product development. The three-day Medical Device & Technology Test Expo, held at Koelnmesse, closes today.
Check the Medical Device & Techology Test Expo website for pdf versions of the workshop and forum presentations: www.medicaldevicetestexpo.com. They will be made available by the end of February 2011.
A Medical Device Master File is a submission to U.S. FDA that may be used in support of premarket submissions to provide confidential detailed information about establishments, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more medical devices. Registrar Corp's team of medical device regulatory experts provides guidance as to required elements, formats, and particularities of Medical Device Master File submissions. For assistance submitting a Medical Device Master File, simply click the Medical Device Master File Certificate shown on the left.
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