Less Than 90 Days Until the RoHS2 Directive Impacts Your Medical Devices

Northwire – NWI Lab360 highlights 10 critical requirements to ensure CE-mark compliance

OSCEOLA, WI. – May 1, 2014 – Cable engineering company, Northwire, Inc. ,  (NWI) capitalizes on 42+

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 13485:2003 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. 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.

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.

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.

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

Mercury

Cadmium (.01 percent)

Hexavalent Chromium

Polybrominated biphenyls

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

July 22, 2015 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 RESPONSIBILITY

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 our consumer testing capabilities at

800.468.1516,cableinfo@northwire.com or through Live Chat.

About Northwire       

Cable manufacturer, Northwire, Inc., celebrating over 42 years of innovation, is a registered woman-owned

small business with corporate headquarters and manufacturing in Osceola, Wisconsin and engineering 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, retractile

cords, cable 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.