Be confident of medical device market approval
Electrical and electronic equipment represents the fastest growing source of waste in the European Union (EU). So-called E-waste often contains hazardous substances that can contribute to land contamination and ground water pollution, and pose health risks to consumers. Issued in 2003, EU Directive 2002/96/EC, Waste Electrical and Electronic Equipment (WEEE), was implemented to reduce the creation of electrical and electronic waste and to encourage the recovery, reuse and recycling of electrical and electronic products. However, the EU Commission’s Directorate General Environment estimates that only about one third of electrical and electronic waste in the EU is being recycled.
The EU Directive 2012/19/EC (on Waste Electrical and Electronic Equipment (also known as WEEE II) represents the EU’s latest effort to increase recycling of and reduce waste from electrical and electronic equipment. Under WEEE II, EU Member States must achieve collection rates of 45% beginning in 2016 and collection rates of 65% by 2019. Most important, all categories of electrical and electronic equipment, including medical devices and in-vitro medical devices, will be subject to WEEE II recovery targets by 13 August 2012.
In order to achieve the recovery targets established in WEEE II, manufactures (otherwise known as producers in WEEE II) are required to establish processes and systems to ensure the safe and effective collection and recovery of most electrical and electronic waste. Medical devices such as in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices are excluded from the scope of WEEE II.
Manufacturers are also encouraged to maximise the use of recoverable and recyclable materials in their products, and to design products in order to facilitate the dismantling and recovery of recyclable materials. Manufacturers are required to appoint an authorised representative in each EU Member State, who is legally responsible for fulfilling the manufacturer’s responsibilities under WEEE II.
In addition to the requirements of WEEE II, medical device manufactures may be subject to other EU directives and regulations addressing the control and recycling of electrical and electronic waste. These include EU Directive 2011/65/EU on the restriction of the use of hazardous substances (RoHS II), and as well as the EU directive 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 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.