RoHS was introduced by the European Union in 2003 with the intention to regulate the large amounts of toxic electronic waste; setting targets for collection, recycling and recovery of electrical goods. However, there were several flaws in the initial guidelines and after a lot of discussion, the European Parliament RoHS recast, or RoHS 2.0 was adopted by the European Union on June 8th 2011.
So what does the bureaucratic heavyweight number 2011/65/EU mean for manufacturers of medical systems?
RoHS 2.0 specifically addresses and restricts the use of six substances: Lead (Pb), Hexavalent Chromium (Cr6+), Mercury (Hg), Polybrominated, Biphenyls (PBB),
Cadmium (Cd) and Polybrominated Diphenyl Ethers (PBDE)
At a first glance, the RoHS recast is visibly more comprehensive and increasingly autonomous. One key aspect of the directive is that it now includes categories 8 and 9, which covers medical devices as well as monitoring and control instruments. This has important implications for OEMs in this space, as they were previously exempt from RoHS regulation.
Now, these products need to be compliant by July 22nd 2014. In addition, RoHS 2.0 also added the eleventh category for “other electrical and electronic equipment”. This catch-all category was designed to cover any devices that weren’t covered in other categories.
New requirements for CE compliance
As a result of these changes, medical OEMs must comply with a number of new requirements, the first being CE compliance. Previously, the RoHS directive did not require any specific labelling in order to prove compliance.
Many manufacturers adopted their own marks to indicate compliance along with a declaration of conformity. In addition, because the WEEE directive is closely linked with RoHS, the waste bin logo with an “X” through it was also used as an indicator that the product is RoHS compliant.
RoHS 2.0 also changes the marking requirements. In order to show RoHS conformity, the CE marking is required. CE markings and obligations will be immediately required for products covered in the scope of the RoHS recast.
Now that RoHS 2.0 compliance requires the CE marking, documentation is critical. 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.
Easing the pain for medical OEMs
The transition to a RoHS 2.0 compliant product can impact the overall performance of the product, requiring extensive reliability, verification and validation efforts. Moreover, custom electronic and mechanical component suppliers will be a large challenge for medical OEMs, as they may not 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. EMS companies have been working with non-exempt OEMs and their supply chains for years and are ideally positioned to support medical OEMs though this transition.
Rather than dealing with the challenge single-handedly, medical OEMs strongly benefit from the support of an experienced EMS partner, working with established RoHS compliant supply chains to obtain an effective unit cost solution.
Not only does this option minimise risk in revenue losses, but OEMs can also make secure business decisions, as their EMS partner can assist by developing new RoHS 2.0 compliant prototypes as well as conducting extensive verification and accelerated life testing. Furthermore, teamed with an EMS provider, medical OEMs can conduct on-going audits within the supply chain to confirm continued RoHS compliance.
Despite the fact that the recast is not in place for another 3 years, it should not be underestimated. Medical OEMs must not be disheartened by the vast scope of the new directive, instead they are well advised to make arrangements now with a reliable partner on their side to comply with the RoHS recast comfortably and in time to ensure they maintain market share in the dynamic medical technology space.