Medical RoHS: Get Your Database Ready

Medical device manufacturers will have to manage a huge dataset to comply with incoming RoHS regulations, as well as other rules and standards relative to their industry.

Manufacturers of these products will have to meet RoHS requirements over the next few years, following the EU’s 2011 decision to expand the standard. The substance restrictions under RoHS apply to certain types of medical devices from July 22, 2014; and to other types from July 2016. There are also deadlines in the next few years for monitoring and control equipment, and other currently exempted products.

Writing a blog for TTI Inc, Mike Kirschner says companies shouldn’t try to create a custom solution in-house, because a wide variety of tools are already available. Manufacturers will have to find out if upstream suppliers may have specified restricted substances, and they must get their suppliers to demonstrate compliance – either through validated control over material selection, or through test results over time, or both.

Last year, Varian Medical Systems, a $2.6 billion manufacturer of medical devices and software, said it was reducing its time to implement engineering changes from 18 to five days with two sustainability products from SAP. The manufacturer said the SAP Environment, Health, and Safety Management and SAP Product Life Cycle Management applications were helping it comply with RoHS and REACH.

And this year Underwriters Laboratories launched a due diligence service to support medical devices and laboratory equipment manufacturers’ compliance with RoHS.

Takeaway: Medical device manufacturers should get ready to comply with the EU RoHS regulations, set to apply to many such companies in July.

Tamar Wilner is Senior Editor at Environmental Leader PRO.

Picture credit: SAP, PLM software