Medical Device Market Approval & Certification

Medical Devices and the EU’s Waste Electrical and Electronic Equipment (WEEE)(英語)



Medical Devices and the EU’s Waste Electrical and Electronic Equipment (WEEE)

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.

EU Directive 2012/19/EC

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.

Why choose TÜV SÜD

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.

Our services at a glance

  • Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
  • Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
  • Other testing and certification services - In addition to medical device compliance to the requirements of the EU’s WEEE II Directive, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.

Your benefits at a glance

  • Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognised by regulatory authorities around the world for its extensive experience with all types of medical devices.
  • Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
  • Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
  • Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
  • Expert partnership - TÜV SÜD Product Service has a long record of technical and regulatory expertise for medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.


Wearable Doctors





EU MDR and its impact on cardiovascular manufacturers

How to ensure a smooth transition to MDR certification.

Learn More



Site Selector