Friday, 21 February 2014

EU Amendment of RoHS Exemptions for Medical Devices and Fluorescent Lamps

From the 22nd July 2014, medical devices, excluding active implantable devices (IVD), will need to comply with the RoHS recast. Then, from 22nd July 2016, IVD devices will also need to comply.

Due to various reasons such as safety, a negative impact to the environment or no substitutes etc, the European Parliament and the Council have amended Annex IV of RoHS recast.

Therefore on 9th January 2014, a total of 16 amendments to the RoHS Directive were published.15 of which affecting medical devices (Annex IV) and also a new exemption for mercury in certain compact fluorescent lamps which will be included in RoHS Annex III.

In accordance with Article 4(1) of the RoHS recast, Member States need to ensure that electrical and electronic equipment placed on the market (including cables and spare parts for repairs, reuse, updating of functionalities or upgrading of capacities), do not contain the restricted substances beyond the threshold in RoHS Annex II.

Member States need to bring into force the laws, regulations and administrative provisions necessary to comply with RoHS recast by the last day of the sixth month after these amendments enter into force.

To read the article in full and to view a table of all consolidated exemptions, please visit the SGS website.

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