RoHS II – Prohibitions on substances for electromedical devices binding since 22 July 2014
The Directive 2011/65/EU (RoHS II) has also applied for medical devices since 22 July 2014.
Whilst the scope of the prior version of the RoHS Directive (2002/95/EC) was restricted to selected categories of electrical and electronic devices and medical devices were expressly excluded, the new Directive in principle applies for all electrical devices. Although long transitional periods apply for devices which have not to date been covered by the Directive, the transitional period for medical devices, however, expired on 22 July 2014.
Since this date, new requirements have applied for manufacturers, importers and distributors of electrical or electronic medical devices.
Prohibitions on substances / Concentration limits
On the one hand, the prohibitions on substances now have to be observed. Electrical and electronic medical devices may no longer contain lead, mercury, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers in a concentration of more than 0.1 % in weight and for cadmium 0.01 % by weight. The concentration limits do not refer to the device as such, but to homogenous material.
On the other hand, compliance with the requirements of RoHS II has to be evidenced by a conformity assessment procedure and has to be made the subject of a conformity declaration. A CE mark also has to be affixed to electrical or electronic medical devices.
Devices which no longer meet the requirements which have applied since 22 July 2014 are no longer marketable. To prevent risks, manufacturers of electrical or electronic medical devices should therefore review whether all necessary precautions have been taken with respect to the procurement of raw materials and components to ensure reliable compliances with the prohibitions on substances. Importers and distributors should also ensure that they only market RoHS compliant product and have taken the necessary contractual precautions.