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RoHS/REACH Questions Answered by TÜV Rheinland Experts, Part 2

Posted by TUV Rheinland on Jan 15, 2016 8:00:00 AM
TUV Rheinland

What is expected for RoHS and REACH compliance for AIMD products in 2019 and beyond?

There are very few things exempt from the RoHS directive, and almost nothing is exempt from REACH, save natural resources, cosmetics and some other instances. However, AIMD products (Active Implantable Medical Devices), including programmers, continue to be exempt from RoHS. 

Programmers used for the AIMD do not fall under the scope of ROHS2 as supported by the directive and the medical device sector CE marks and practices. An AIMD means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body, or by medical intervention into a natural orifice in which it is intended to remain after the procedure. 

A programmer is a device for communicating with an actively implantable device, and consequently the level of risk associated with a programmer is similar to that for the AIMD because a malfunction in the programmer may lead to a malfunction in the device. Therefore both the device and the programmers remain exempt and there is no word on the market or in the EU of any inclusion of AIMDs in the near future. 

Please visit our website for more information on REACH compliance.

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