Only 6 Months Until the RoHS2 Directive Impacts Your Medical Devices
Northwire – NWI Lab360 highlights 10 critical requirements to ensure CE-mark compliance
OSCEOLA, WI. – Northwire, Inc. (NWI) capitalizes on 41+ years of collaboration with the medical device industry and leverages over 1,200 tenured years of life science market expertise to navigate the complexities of international and domestic, regulatory, agency and environmental compliance. Fortified with cutting-edge testing capabilities, NWI's rigorous quality management system supports your ability to achieve RoHS2 compliance cost-effectively with maximum efficiency. ISO 13854:2003 Certified, Northwire is an innovative solutions provider in the design and manufacture of custom technical wire and cable, retractile cords, cable assemblies, connectors, harnesses and contract manufacturing.Â
"Northwire is committed to ensuring the success of our valuable customers, which is why we invested in the latest consumer testing technology to validate compliance to RoHS2, REACH and other requirements. Partnering efforts with NWI, customers can achieve time and cost reductions associated with outside lab testing or non-compliant events," emphasizes Mark Perrott, Executive Vice President responsible for quality, legal and human resources.Â
Perrott explains, "Our field-proven x-ray fluorescence material analyzer detects restricted substances instantly and provides both an electronic and hard copy record. Northwire's in-house, non-destructive test capability is the same technology utilized by regulatory agencies."
Originally published in July 2011 in the Official Journal by the European Commission, the Recast RoHS Directive requires every manufacturer of electrical and electronic equipment, including medical devices, to meet specific conformity. NWI breaks down the complexities of 10 critical RoHS2 Directive requirements to ensure your CE-mark compliant in time for the pending deadline:
No. 10. TIME IS OF THE ESSENCE
While the legal enforcement dates for commercial medical device compliance is July 22, 2014, importers requests for product compliance will typically start 6 months before the legal deadline. To ensure that all inventories are compliant, you must have adopted the directive by June 2013 – Less than one month away.
No. 9. CE 'MARKS THE SPOT'
To ensure CE-mark compliance, you must adjust your target to meet compliance with the RoHS2 Directive, because you cannot CE-mark products without it. Here's why: the Recast RoHS Directive IS a CE-marking directive which means your medical device and equipment CANNOT CE-mark the way you used to with the Medical Device, EMC and Low Voltage Directive.Â
No. 8. IT'S THE LAW
For those wondering, does this apply to me? Let's be crystal clear – every European Union country was required to adopt the RoHS2 Directive into National Law by January 2, 2013. This date obligates countries to enforce 'market surveillance' of your products. Additionally, requirements to assess all EEE manufacturers to demonstrate compliance with RoHS2 are legally enforceable. Some of the responses to non-compliant products by the 'surveillance authority' include physical and laboratory checks on samples, documentation checks, handling complaints, ruling on penalties, withdrawing, prohibiting or restricting your products from the EU.
No. 7. BURDEN OF PROOF
RoHS2 validation and verification is your responsibility and is required on various forms of technical documentation not limited to the Declaration of Conformity.Â
No. 6. SUBSTANCE ABUSERS BEWARE
The RoHS2 Directive outlines the six hazardous and restricted substances 'with maximum concentration values tolerated by weight to homogeneous materials' all of which 0.1 percent unless otherwise indicated:
• Lead
• Hexavalent Chromium Â
• Mercury
• Polybrominated biphenyls
• Cadmium (.01 percent)
• Polybrominated diphenyl ethers
No. 5. NOT OVER YET
Prior to the recast, there were eight product categories. If you are in these categories and have not implemented the January 2, 2013 RoHS2 Directives, you must do it now:
• Household appliances – large and small
• Equipment – IT, communications, lighting and consumer
• Electrical and electronic tools
• Toys, leisure and sports equipment
• Automatic dispensers
No. 4. MORE TO COME
Mark your calendars because the formerly excluded categories, are now included effective:
• July 22, 2014 Medical devices (less 6 months to ensure compliant inventory)
• July 22, 2014 Monitoring and control instruments
• July 22, 2016 In-vitro diagnostic medical devices
• July 22, 2017 Industrial monitoring and control instruments
• July 22, 2019 All other electrical and electronic equipment not covered
• 2020 Active implantable medical devices reviewed for inclusion
No. 3. LOOK WHO'S TAKING RESPONSIBLE
According to the RoHS2 Directive, 'Economic Operators' are the responsible party to ensure CE-mark compliance:
• Manufacturer
• Authorized Representative
• Importer
• Distributer
No. 2.  YOUR NEW FAVORITE 10-LETTER WORD: C-O-M-P-L-I-A-N-C-E
While RoHS2 Directive Articles 7 through 10 outline the specific responsibility of each party in the supply chain, rely on Northwire cable engineering company subject matter experts to navigate consumer product testing, technical documentation, internal production control procedures and the quality management system to assist you in an expedient and cost-effective program to ensure CE-mark compliance. In the event your material does not meet the RoHS2 Directive, rely on NWI's recommendations to alternative strategic suppliers that have already been validated. Northwire's comprehensive database of validated materials will help you quickly respond to requests of the 'surveillance authority', while it may take other, less-sophisticated suppliers months to produce the required documentation which could prohibit your CE-mark.
No. 1. GET AHEAD OF THE COMPETITION
NWI's comprehensive consumer product testing capabilities and rigorous quality management systems validate RoHS2 specifications ensuring your CE-mark compliance. With a faster, less expensive go-to-market strategy, you have a decisive advantage over your competitor.
Northwire's latest investment in robust testing capabilities represents a small token of our four-decade commitment to reciprocating our customers' loyalty and achieving the highest level of customer satisfaction. The cable manufacturer, NWI, leverages professional certifications in Six Sigma, Lean, Project Management and the American Society for Quality to ensure the highest quality wire and cable products with the fastest lead times. Certified to Quality Management Systems ISO 13485:2003, ISO 9001:2008 and AS9100C:2009, as well as CSA qualified to ISO 17025, Northwire is renowned for providing personalized service excellence with quotes in 24 hours or less, no minimum order quantity, same day custom products, free cable and wire samples and rapid cable prototyping.
Find out more about Northwire solutions and customized programs at 800-468-1516, cableinfo@northwire.com or through Live Chat.
About Northwire
Cable manufacturer, Northwire, Inc., celebrating over 41 years of innovation, is a registered woman-owned small business with corporate headquarters and manufacturing in Osceola, Wisconsin, a professional sales & design engineering center in Carson City, Nevada and manufacturing in Santa Teresa, New Mexico. The cable engineering company is the premier partner for the design, manufacture and contract services of custom technical products including wire and cable, retractiles, assemblies, connectors, harnesses, injection molding, over-molding and contract engineering and OEM (Original Equipment Manufacturer) for diverse applications in life sciences, energy, mil spec, industrial, machine vision, architectural lighting, underwater, and more.  Northwire is a member of NDIA (National Defense Industrial Association), NCMA (National Contract Management Association), RIA (Robotics Industries Association), AIA (Automated Imaging Association), Fieldbus Foundation, ODVA (Open DeviceNet Vendors Associations) and WAI (Wire Association International), among others.
For more information, visit www.northwire.com.
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