In 2014, the substance restrictions of the RoHS Directive will be applicable to medical devices. Under EU Directive 2011/65/EU (also known as RoHS II), medical devices will be subject to restrictions regarding the use of hazardous substances as of 22 July 2014, and in vitro diagnostic medical devices will be required to comply with hazardous substances restrictions as of 22 July 2016. For now, active implantable medical devices remain outside the scope of RoHS requirements, but are subject to future review by the EU Commission.
Compliance with the requirements of the EU’s RoHS II Directive requires manufacturers to adhere to the conformity assessment procedures presented in Annex II Module A of EU Commission Decision No. 768/2008/EC: “The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product”.
Medical device manufacturers have to thoroughly review the conformity assessment procedures applicable to their device to avoid delays in the product review and approval process.
In addition to the requirements of RoHS II, medical device manufactures may be subject to other EU directives and regulations addressing the use of hazardous substances and the control of electrical and electronic waste. These include EU Directive 2012/19/EC on Waste Electrical and Electronic Equipment (WEEE II), and EU regulation No 1907/2006 (REACH), as well as EU directives on the disposal of batteries, and on product packaging and packaging waste.
Compliance with the essential requirements of the EU’s directives and regulations applicable to active, non-active and in-vitro medical devices provides manufacturers with access to a marketplace consisting of 500 million consumers. In addition, medical devices bearing the CE marking may achieve faster regulatory review and approval in other global markets. TÜV SÜD Product Service is the world’s largest EU Notified Body for medical devices. In addition, TÜV SÜD’s extensive international network makes it an effective single source for manufacturers seeking global market access for their products.
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