Restriction of Hazardous Substances (RoHS) directive

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 Restriction of Hazardous Substances or RoHS Directive) have restricted the use of the chemicals below and required manufacturers to replace these chemicals in their products with less hazardous alternatives. 

The original restricted substances according to the 2002 directive are: 

• Lead (0.1%) 

• Mercury (0.1%) 
• Cadmium (0.01%) 
• Hexavalent chromium (0.1%) 
• Polybrominated biphenyls (PBB) (0.1%) 
• Polybrominated diphenyl ethers (PBDE) (0.1%) 

New restricted substances that came 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: 

• Bis(2-ethylhexyl) phthalate (DEHP) (0.1%) 
• Butyl benzyl phthalate (BBP) (0.1%) 
• Dibutyl phthalate (DBP) (0.1%) 
• Diisobutyl phthalate (DIBP) (0.1%) 

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 must follow the restrictions regarding the use of hazardous substances since 22 July 2014, and in vitro diagnostic medical devices must 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. 

As the world’s largest EU Notified Body for Medical Devices, TÜV SÜD is qualified to test and certify medical devices according to the RoHS Directive. 

Compliance with 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 above requirements, medical device manufacturers 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), EU regulation No 1907/2006 (REACH), and EU Battery Regulation 2023/1542 and product packaging and packaging waste Directive. 

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 is one of the largest EU Notified Bodies in the world. Regulatory authorities around the world recognise TÜV SÜD for its extensive experience with all types of medical devices. We support a wide range of global markets. 

We are a trusted partner for companies ranging from global manufacturers to regional and local firms. Our extensive international network makes us an effective partner for manufacturers seeking global market access for their products. A Regulatory Foreign Affairs and Clinical Centre of Excellence adds to our expertise. 

TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards. This allows clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs. 

Our technical professionals are actively involved in standards development activities related to medical devices and participate in several key standards committees. TÜV SÜD 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. 

• Voluntary RoHS II compliance assessment for medical devices  
  Basis for this assessment is RoHS II, the technical documentation acc. to Annex II Module A of Decision 768/2008/EC, EN IEC 63000, EN IEC 62321-2 and EN IEC 62474. This assessment is product related and not system related. The assessment can be done off site (in the office) or onsite (in the facility from the manufacturer). 
• TÜV SÜD RoHS certification mark – The TÜV SÜD mark attests that the product has been tested, inspected and certified in accordance with the applicable standards and is RoHS II compliant. 
• Analytical tests (screening tests) – TÜV SÜD Product Service can offer analytical testing services at various locations worldwide through our testing labs. 
• 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 against other relevant standards. 

 

TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognized Notified Body, while our testing services are conducted through TÜV SÜD Testing Labs.