The EU’s Waste Electrical and Electronic Equipment (WEEE)

Electrical and electronic equipment is the fastest-growing source of waste in the European Union (EU). This waste from electrical and electronic equipment (known as e-waste) often contains hazardous substances that can contaminate land and pollute groundwater, thus posing health risks to consumers.

EU Directive 2002/96/EC, Waste Electrical and Electronic Equipment (EU WEEE) was issued in 2003 to reduce the creation of e-waste and 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 e-waste in the EU is recycled.

The EU followed up with an updated directive in 2012. This is the EU Directive 2012/19/EC on Waste Electrical and Electronic Equipment (also known as EU WEEE II).

The aim of EU Directive 2012/19/EC is to contribute to sustainable production and consumption by:

• preventing the creation of WEEE as a priority
• contributing to the efficient use of resources and the retrieval of secondary raw materials through re-use, recycling and other forms of recovery
• improving the environmental performance of everyone involved in the life cycle of EEE

The EU WEEE Directive:

• requires the separate collection and proper treatment of WEEE and sets targets for their collection, recovery and recycling
• helps European countries fight illegal waste exports more effectively by making it harder for exporters to disguise illegal shipments of WEEE
• reduces the administrative burden by calling for the harmonisation of national EEE registers and of the reporting format

Under WEEE II, EU Member States must achieve collection rates of 45% beginning in 2016 and 65% by 2019. Most importantly, all categories of electrical and electronic equipment, including medical devices and in-vitro medical devices, were subject to WEEE II recovery targets by 13 August 2012. As the EU’s largest Notified Body for medical devices, TÜV SÜD is qualified to help medical device manufacturers fulfil the full range of WEEE II requirements.

To achieve the recovery targets established in WEEE II, manufacturers (also known as producers in WEEE II) are required to establish processes and systems to safely and effectively collect waste from electrical and electronic equipment. Medical devices such as in vitro diagnostic medical devices and active implantable medical devices are excluded from the scope of WEEE II.

The Directive also encourages manufacturers to maximise the use of recoverable and recyclable materials in their products, and design products to facilitate the dismantling and recovery of recyclable materials. Manufacturers need to appoint an authorised representative in each EU Member State. This representative is legally responsible for fulfilling the manufacturer’s responsibilities under WEEE II.

In addition to WEEE II, manufacturers may need to follow other EU directives and regulations on the control and recycling of e-waste. These include EU Directive 2011/65/EU on the restriction of the use of hazardous substances (RoHS II), the Battery Regulation EU 2023/1542, REACH Regulation (EC) 1907/2006 and product packaging and packaging waste directive.

Evaluation and Outlook

The Commission is currently evaluating the EU WEEE Directive. This evaluation will assess whether the Directive is still fit for purpose, explore possibilities to simplify the Directive, and determine whether a review is needed. To gather evidence from the public and from a wide range of stakeholders, the Commission held an online public consultation assisted by a study to support this evaluation. The final report of the study will be made publicly available by September 2024.

TÜV SÜD is one of the world’s largest EU Notified Bodies for medical devices. Devices bearing CE Marking from TÜV SÜD may achieve faster regulatory review and approval in other global markets.

Our extensive international network makes us effective at helping manufacturers ensure compliance with international standards and regulations.

We have over 1500 medical device experts worldwide. Our experts are actively involved in standards development activities and participate in key standards committees. We are also a member of Team NB, the European Association of Notified Bodies for Medical Devices, which facilitates the exchange of information on standards and regulations.

Medical device approvals routinely require the implementation of a quality management system. We conduct quality management system certifications, audits and factory inspections consistent with most international regulations and standards. This allows you to get the benefits of coordinated inspections and audits, while optimising time and costs.

Our service includes: 

• Material/composition determination – TÜV SÜD assists producers in establishing the material/composition declaration of EEE products through a database comprising the listed product components together with their weights and component materials, as required for producer registration. 
• WEEE II compliance and registration requirements evaluation – our experts evaluate products to verify whether they fall under the remit of WEEE II. After checking the manufacturer specifications, data and documentation, and material components, we also assist in constructing a bill of materials component list. 
• Registration assistance – manufacturers and importers of EEE goods need to register in every member state of the EU where products are intended for sale. TÜV SÜD assists clients to register as a WEEE II producer with an approved producer compliance scheme in all relevant EU states.