Update: RoHS Directive and the Future of Medical Devices

8/31/11 An update on the decisions made to RoHS Recast was provided by Christine Ruther of Eisner Safety Consultants

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Medical device manufacturers should be aware that the RoHS Directive that regulates hazardous substances in electrical and electronic equipment (EEE) in the EU is being repealed. The change means that medical devices, which have been exempt, will now be included in the directive—with no grandfathering.

Using the EU’s New Approach and New Legislative Framework, the directive moves specification of restricted substances and covered EEE to the Annexes so that they can be easily “adapted to technical progress” (ATP), as follows:

The European Parliament adopted the language for the RoHS Recast in late 2010, and the final step to approve legislation in the Council of the European Union is expected soon.

The change will significantly affect the medical device field. Currently all medical and in vitro diagnostics devices are exempt from the directive. However, the new systems no longer automatically exclude medical device and diagnostic devices, although active implants under AIMDD will continue to be exempt from RoHS. Leonard Eisner from Eisner Safety Consultants says that the reason AIMDD won't be in the directive is that "there are decontamination issues involved with AIMDD that can be complex."

The new legislation has scheduled transition times. Medical devices, as well as monitoring and control instruments, must comply within three years after publication in the EU Official Journal, and IVDs must comply within five years.

—Heather Thompson