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 RoHS 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 requirements of RoHS II, 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.
- 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 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:
- Bis(2-ethylhexyl) phthalate (DEHP) (0.1%)
- Butyl benzyl phthalate (BBP) (0.1%)
- Dibutyl phthalate (DBP) (0.1%)
- Diisobutyl phthalate (DIBP) (0.1%)