Medical Devices fell within the scope of the RoHS2 Directive 2011/65/EU on 22 July 2014.

Most Medical Device (category 8) manufacturers have met the deadline (only just in some cases), but they have known that compliance would have been necessary since 2006 when  ERA Technology published a report on Categories  8 (medical devices) and 9 (monitoring and control instruments) on behalf of the European Commission.

However, compliance has only been achieved with the acceptance of many additional exemptions.

8 years for compliance should be enough, but their current concern is additional RoHS substances which the Commission has said will take effect in July 2017 for products in categories 1 – 7 and 10 and July 2019 for the rest - 8, 9 and 11. Medical (category 8) manufacturers are concerned that this will not be enough time. Although it is 5 years from now, it allows only 2 years after other categories and so compliant components will not be available until 2016/2017 leaving only 2 to 3 years to build and test etc. If medical equipment needs to be redesigned, then extensive reliability testing is needed and it may also be necessary to gain re-approval from a Notified Body for the Medical Device Directive, all of which can take several years at least.

With thanks to Dr Paul Goodman of ERA Technology for his input.




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