Only 6 Months Until the RoHS2 Directive Impacts Your Medical Devices

Online, June 21, 2013 (Newswire.com) - 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.

"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. "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."

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.

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.

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.

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
• 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.

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.

Find out more about Northwire at 800.468.1516, [email protected], or through Live Chat.