Medical devices to be covered by the RoHS Directive

Since 2003 the EU has restricted the use of hazardous substances in electrical and electronic equipment. The most recent RoHS Directive is 2011/65/EC. So far, medical devices have not been affected. However, from 22 July 2014 these devices will be included in the scope of the Directive.

This means that as a medical device manufacturer you will have to demonstrate compliance. The RoHS Directive sets maximum levels for materials such as heavy metals (lead, mercury, exavalent chromium and cadmium) as well as for brominated flame retardants (PBB and PBDE).

In this context, a medical device is any instrument, piece of apparatus, etc. designed to be used for diagnostic or therapeutic purposes. However, implanted products which remain in the patient's body are excluded. Laboratory equipment for in vitro diagnosis will be included in the scope from 22 July 2016, i.e. two years later than other devices.

This is an indicative list of devices covered by the new RoHS requirements:

  • Radiotherapy equipment
  • Cardiology equipment
  • Dialysis equipment
  • Pulmonary ventilators
  • Nuclear medicine equipment
  • Analysers
  • Freezers
  • Fertilization tests
  • Other appliances for detecting, preventing, monitoring, treating, alleviating illness, injury or disability
  • From 22 July 2016: laboratory equipment for in vitro diagnosis.

How we can help you
Our RoHS test labs are situated in Europe and China. We offer a full range of services, not just in product testing and certification, but also in consultancy and risk assessment. These can help you meet all regulatory requirements for the EU market, efficiently and quickly.

For more information about this service or other information, please contact us.

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