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June 2011 is expected to bring with it a much-anticipated event – the publication of RoHS II in the Official Journal of the European Union.

Any RoHS directive items previously in question are now being clarified in the revised edition and as a result, RoHS II is on the way to becoming a CE Mark Directive. No new restricted substances have been introduced and the exemption of Medical Devices in the current directive 2002/95/EC is being phased out. As it evolves, manufacturers, importers and distributers 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 8 and 9 are being gradually phased out. This includes medical devices (three years after RoHS II publication, category 8), in-vitro diagnostics (five years after RoHS II publication, category 8), control and monitoring devices (three years after RoHS II publication, category 9), industrial control and monitoring instruments (six years after RoHS II publication, category 9).

Out of the grey for Electrical and Electronic Equipment

At the same time the new directive is expected to cover 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).’ Also EEE needing electric currents or electromagnetic fields to fulfil at least one intended function will be included in the future. Thus electrical and electronic equipment types that were not covered before will be 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 is expected early in June 2011 with the directive becoming mandatory legislation 20 days after publication in the Official Journal of the European Union. At that point, member states have eighteen months to enforce the directive into law. Until that 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 which will automatically enforce 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 In its current draft form, RoHS II 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 8 and 9 EEE. However, all on-going exemptions will 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 of homogeneous materials was an adaption made by 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 will be a CE Mark Directive RoHS II is set to become 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 now to be shared between manufacturers and importers and distributors; CE declaration remains the manufacturer’s obligation, while the release of compliant products onto the EU market must be controlled by importers and distributors. Once the RoHS II is included, the CE mark will not only mean that an electrical or electronic product complies with all applicable regulations - for example, the low voltage directive or the electromagnetic compatibility requirement – it will also mean compliance with RoHS. Thus product compliance and conformity assessment will now include the obligation to comply with RoHS. If RoHS compliance is not assured, the application of the CE mark will violate 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.

If you need further information, our experts would be glad to hear from you. Contact:

Dr. Udo Krischke
Global Technical Manager
SGS Consumer Testing Services

SGS
Im Maisel 14,
Taunusstein,
Germany,
Postal code: 65232
t: +49 6128 744 235
Website: www.sgs.com/medicaldevices

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