On July 1, 2011 the RoHS II Directive 2011/65/EU was published in the Official Journal of the European Union. All amendments made in this edition mirrored those in the preceding draft publication.
The recast edition of the RoHS Directive contains all the updates that were proposed within the final draft document issued on November 24, 2010. This means that, as expected, any RoHS Directive items previously in question have now been clarified and as a result, RoHS II is now a CE Mark Directive. No new restricted substances have been introduced and the exemption of Medical Devices in the previous directive 2002/95/EC is being phased out over a transition period. As the directive continues to evolve, manufacturers, importers and distributors of medical devices all need to be aware of the implications the changing RoHS II will have on products over the coming years.
Phase out plan for Medical Devices exemptions
In the new RoHS directive product exemptions from categories eight and nine are being gradually phased out. This includes medical devices (three years after RoHS II publication, category eight), in-vitro diagnostics (five years after RoHS II publication, category eight), control and monitoring devices (three years after RoHS II publication, category nine), industrial control and monitoring instruments (six years after RoHS II publication, category nine).
Out of the grey for Electrical and Electronic Equipment
At the same time the new directive covers all but a very few instances of Electrical and Electronic Equipment (EEE). Annex I of the directive introduces a new, eleventh product category – Other EEE not covered by any of the categories above (categories 1–10). Further to this, EEE needing electric currents or electromagnetic fields to fulfill at least one intended function are expected to be included in the future. Thus, electrical and electronic equipment types that were not covered before are covered by RoHS II, including formerly grey zone items such as electric toys.
Timescales for adoption of the new directive
Formal adoption of RoHS II by the European Council occurred in early July 2011 with the directive becoming mandatory legislation 20 days after it was published in the Official Journal of the European Union. At that point, member states were given eighteen months to enforce the directive into law. Until this happens, the current RoHS directive 2002/95/EC remains in force. It needs to be considered though that some EU member states may have national laws in place automatically enforcing amendments of directive 2002/95/EC.
Following timelines of RoHS II this means that regular medical devices are in scope by mid 2014 and in-vitro diagnostic medical devices are in scope by mid 2016 at the latest.
Limited exemptions remain in RoHS II
The RoHS II directive exempts ten general types of electrical and electronic equipment. Active implantable medical devices are among of them.
In addition to these exempt general types of EEE, there are still some specific exemptions of restricted substances in specific applications. Annex III and Annex IV define where otherwise restricted substances may be applied. Annex III lists general exemptions applicable to all EEE and Annex IV lists some additional exemptions only applicable to categories eight and nine EEE. However, all on-going exemptions now have expiration dates.
In order to enforce coherence with REACH legislation, a process for the exemption of substances has been introduced. This allows exemptions to be granted for periods of five to seven years, depending on product category. Interested parties have to make sure to re-apply for pro-longing exemptions in sufficient time.
RoHS II defines Homogeneous Material
RoHS II introduces a definition of homogeneous material as being:
“One material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be mechanically disjointed into different materials, meaning that the materials cannot be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes.”
This overcomes the issue that the previous definition was adapted from that of the Technical Advisory Committee.
No new restricted substances under RoHS II
RoHS II introduces no new restricted substances. What it does, however, is to introduce a simplified mechanism for the review and amendment of the restricted substances list in the future. Substances highlighted for future review include: hexabromocyclododecane (HBCDD), phthalates (DEHP, BBP, DBP) and nanomaterials.
RoHS II is now a CE Mark Directive
RoHS II is now a CE Mark directive, which means that CE marking will be affixed to all finished products, as per Module A of Annex II of 768/2008/CE. With CE marking the responsibility is shared between manufacturers, importers and distributors; CE declaration remains the manufacturer’s obligation, while importers and distributors must control the release of compliant products onto the EU market. As the RoHS II is included, the CE mark not only means that an electrical or electronic product complies with all applicable regulations - for example, the low voltage directive or the electromagnetic compatibility requirement – it also indicates compliance with the RoHS. Thus, product compliance and conformity assessment now includes the obligation to comply with RoHS. If RoHS compliance is not assured, the application of the CE mark violates EU law.
SGS can help ensure compliance with RoHS II. Its global restricted substances service enables full support of products with REACH, SHVC and other relevant international, national and regional regulations and legislation. SGS can also provide compliance assessment, which is essential for the preparation of the CE declaration of conformity.
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Medical Device Team
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