NORTHBROOK, Ill., April 30, 2013 – UL (Underwriters Laboratories), a world leader in advancing safety, announced today the launch of a new program supporting medical devices and laboratory equipment manufacturers in their RoHS II Directive (2011/65/EU) compliance efforts.
Many manufacturers of medical and laboratory equipment previously excluded from the Scope of the original RoHS Directive are now finding that their devices are within Scope of the recast RoHS II Directive. Manufactures placing these devices in Europe must be in compliance with the new Directive by July 22, 2014. Due diligence on the part of these manufacturers is required to ensure that their Declaration of Conformity and Technical File meets the applicable requirements. UL offers these manufacturers support in their due diligence efforts, including a gap analysis of their process, compilation of documents supporting the technical file, analytical testing and more.
"In order to legally market devices in the EU, medical device and laboratory equipment manufacturers must comply with many regulations, including the new RoHS II Directive," said Anil Patel, vice president and general manager of UL health sciences. "This program gives manufacturers needed support in helping to ensure that their products are in full compliance with not only safety, but environmental regulations as well – an area which is receiving increasing focus world-wide."
Under the RoHS II Directive, end-product manufacturers will work with their suppliers to manage compliance and compile technical documentation as evidence of compliance. Because the approach required by the legislation is of a general nature, integrating RoHS assessment services with other regulatory assessments can help manufacturers streamline, and thereby improve, business processes.
"We view the RoHS II Directive as a positive move in protecting our environment, and right in line with our mission at UL to support the production and use of products which are physically and environmentally safe," said Mark Leimbeck, Program Manager for UL’s Health Sciences Industry. "This initiative provides us an opportunity to actively engage the industry, support streamlined efforts to ensure regulatory compliance, and provide a safer and cleaner environment for our children and ourselves."
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