13 Jan 2012
The RoHS recast – Why medical OEMs need to get on their marks now
Peter Winnington-Ingram, Senior Site Director at Plexus, looks at how medical OEMs will be affected by the RoHS recast
While the medical electronics industry boasts it is a dynamic market, responding to the evolving needs of patients and medical practitioners, it is also strictly controlled by both European and national regulations.
The most recent change to legislation was the RoHS recast, or RoHS 2.0, which was adopted by the European Union on June 8th 2011. The original RoHS was introduced by the European Union in 2003 to regulate the large amounts of toxic electronic waste and set out criteria and targets for the collection, recycling and recovery of electrical goods. The recast – 2011/65/EU as it’s otherwise known – aims to address some of the flaws of the initial guidelines and has significant impact for medical OEMs.
Restriction of substances
RoHS 2.0 specifically addresses and restricts the use of six substances in electrical and electronic products released in the European Union: Lead (Pb), Hexavalent Chromium (Cr6+), Mercury (Hg), Polybrominated, Biphenyls (PBB), Cadmium (Cd) and Polybrominated Diphenyl Ethers (PBDE). Whereas in the past this was not an issue for medical OEMs, it is now something they must keep in mind from initial design to manufacture.
Introduction of new RoHS categories
At a first glance, the RoHS recast is visibly more comprehensive. One of the key aspects of the directive is that categories 8 and 9 are now covered by the legislation, which includes medical devices as well as monitoring and control instruments.
The implication for OEMs in this space is clear: they are no longer exempt from RoHS regulation and products in these categories must be compliant with RoHS 2.0 guidelines before the deadline of July 22nd 2014. In addition, RoHS 2.0 also introduced an additional category for “other electrical and electronic equipment” as a catch-all for other devices which do not fit succinctly within other defined categories.
Achieving CE compliance
As a result of this new legislation, medical OEMs must comply with a number of new requirements, the first being CE marking whereas in the past the RoHS directive did not require any specific labelling in order to demonstrate compliance.
Many manufacturers devised their own marks to indicate compliance along with a declaration of conformity. The WEEE directive’s waste bin logo with an “X” through it was also used to indicate that the product is RoHS compliant, since the WEEE directive is closely linked to the RoHS directive.
Now, RoHS 2.0 has changed the marking requirements and in order to show RoHS conformity, CE marking is required. CE markings and obligations will be immediately required for products covered in the scope of the RoHS recast – including new categories 8 and 9 governing test and medical devices.
Documentation is critical to show CE marking has been achieved in line with RoHS 2.0 guidelines. Medical OEMs will need to include evidence, typically individual Certificates of Conformity for each (BOM) component of their product and the (non-BOM) material used to assemble/manufacture the product. Documents in the technical file often include component data, formal descriptions of process controls, product evaluations, risk assessment and test results pertaining to the product. This technical file must be available to proper authorities, upon request and must be kept on record for 10 years from the date of placing the product on the EU market – more admin than was previously expected in the past.
Future requirements for compliance with RoHS 2.0
Moreover, the CE marking is not the only alteration OEMs have to factor in when planning and designing devices. Within the next three and a half years, all medical devices that fall under that category have to obtain compliance, affecting first and foremost medical OEMs given the duration of typical medical design and regulatory approval cycles.
So what can be done now, to make the transition as frictionless as possible?
Easing the pain for Medical OEMs
The transition to a RoHS 2.0 compliant product can impact the overall performance of the product, as extensive reliability, verification and validation efforts are necessary. Moreover, it will be a challenge for medical OEMS to find custom electronic and mechanical component suppliers who can provide RoHS complaint processes or materials.
Looking ahead, ensuring compliance for all devices with the new directive in time can seem to like an overwhelming task for many medical OEMs, but they do not need to pursue RoHS 2.0 compliance alone. Working with a product realization partner who has completed projects with non-exempt OEMs and their supply chains can ensure medical OEMs get the support they need through the transition period.
Leveraging the support of a Product Realization partner
Rather than dealing with the challenge single-handedly, medical OEMs strongly benefit from the support of an experienced design and manufacturing partner, working with established RoHS compliant supply chains to obtain an effective unit cost solution.
This will not only minimise risk of revenue losses, but OEMs can also make secure business decisions, as their partner can assist by developing new RoHS 2.0 compliant prototypes as well as conducting extensive verification and accelerated life testing. Furthermore, teamed with a product realization provider, a medical OEM can carry out on-going audits within the supply chain to ensure continued RoHS compliance.
Future proof your medical devices for 22nd July 2014
While RoHS 2.0 will not come into effect until 2014, the impact it will have on the medical electronic and electrical device industry should not be underestimated. Medical OEMs should not be disheartened by the vast scope of the new directive. To avoid issues head on, medical OEMs are well advised to make arrangements now with a reliable EMS partner on their side to comply with the RoHS recast comfortably and in time to ensure they maintain market share in the dynamic Med Tech space.
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About the author
Peter Winnington-Ingram holds a MA in Engineering from Cambridge University and has broad international project management and technology experience from senior research and development positions across engineering, security and telecommunications industries. He joined Plexus in August 2004, advancing to the position of Design Centre Manager in February 2006. He was named Senior Site Director at Plexus’ Livingston Design Centre in June 2009 and is responsible for the strategic direction of the Design Centre and ensuring it meets its long-term goals and objectives. Winnington-Ingram oversees all functions at the facility including project management, concept design, product development and commercialisation. Through his leadership, Plexus continues to advance its engineering capabilities to deliver optimised product realization solutions to its customers as a single, integrated accountable partner.
Plexus is unique within the Electronic Manufacturing Services industry with more than 25 years’ experience in turning customer's concepts into world-class products through our unique set of value-added product realization solutions. These solutions include mechanical, electronic and software design, printed circuit board development, prototyping services, new product introduction, material procurement and supply chain management, printed circuit board and higher level assembly, test development, in-circuit and functional testing, final system box build, fulfillment, service, and repair.
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