12 Dec 2011

The new directive - RoHS 2 – no longer excludes medical devices.  After July 22 2014, all medical devices meeting the definition of electrical and electronic equipment (EEE), will be restricted at a homogenous level from using lead, mercury, cadmium, hexavalent chromium, and two polybrominated flame retardants.  There is a transition period for in-vitro diagnostics equipment (July 22, 2016) and exclusion for active implanted medical devices. 

But what does this really mean? This means that medical device manufacturers have just over two years to assess their current products, re-design, re-qualify, and re-submit for various legislative mandates (e.g. FDA, Health Canada).  If a medical device manufacturer has not started this process, they are at an incredible risk of being barred from selling their product(s) into the European Union after their date of compliance.  The Consumer Electronics Association published a report   that identified one of the leading causes of financial loss arose from the failure of having products redesigned, compliant, and available for sale in time.

Are you interested in learning more about the RoHS2 Directive? If so, you can find more information here.

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