Underwriters Laboratories (UL) announced a new program that supports medical device and laboratory equipment manufacturers in their RoHS II Directive (2011/65/EU) compliance efforts.

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. Manufacturers 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.

In announcing its program, UL said it offers manufacturers support in their due diligence efforts, including gap analyses of their processes, compilation of documents supporting the technical files, and analytical testing.

“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 worldwide,” says Anil Patel, vice president and general manager of UL health sciences.

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 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 that are physically and environmentally safe,” said Mark Leimbeck, program manager for UL’s Health Sciences Industry.