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European Union (EU) Directives have restricted the use of certain hazardous substances in electrical and electronic equipment for more than a decade. Originally issued in 2002, EU Directive 2002/95/EC(also known as the RoHS Directive) restricted the use of the six chemicals lead, cadmium, mercury, and hexavalent chromium, as well as flame retardants polybrominated biphenyls (PBBs) and polybrominated dipheny ethers (PBDEs). Under this directive, manufacturers are required to replace these chemicals in their products with less hazardous alternatives.
Since 2014 the substance restrictions of the RoHS Directive have been applicable to medical devices. Under EU Directive 2011/65/EU (also known as RoHS II), medical devices have to follow the restrictions regarding the use of hazardous substances since 22 July 2014, and in vitro diagnostic medical devices have to follow the restrictions of the hazardous substances since 22 July 2016. For now, active implantable medical devices remain outside the scope of these 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 are advised 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 abovementioned requirements, 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.
New restricted substances that come into effect on 22 July 2019 for Electrical and Electronic Equipment (EEE); and 22 July 2021 for medical devices, in-vitro medical devices and monitoring and control instruments:
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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Voluntary RoHS II compliance assessment for medical devices - The basis for this assessment is RoHS II, the technical documentation according to Annex II Module A of Decision 768/2008/EC, EN 50581, IEC 62596 and IEC 62474. This assessment is product related and not system related and can be done off-site at TÜV SÜD laboratories or on-site at your manufacturing facility.
TÜV SÜD RoHS certification mark - The TÜV SÜD mark attests that the product has been tested, inspected and certified in accordance with the directive.
Analytical tests (screening tests) - TÜV SÜD Product Service can offer analytical testing services at various locations worldwide.
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.
Other testing and certification services - In addition to testing for compliance with the substance restrictions of the EU’s RoHS II Directive, TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards.
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