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RoHS WEEE Questions Re Medical Devices

  • RoHS
  • Indium Corporation
  • I read your article "RoHS: The Fine Print" with interest. Your point about chromium in screw plating points out the level of detail with which this issue needs to be addressed. I have been attending RoHS/WEEE seminars and reading to find out as much as I can about compliance. Presently, the RoHS directive exempts medical equipment manufacturers. The company I work for produces disposable medical devices as well as pump and compounding equipment. I understand the exemption can be withdrawn at any time. As a matter of fact, the EU was supposed to have reviewed all exemptions by 13FEB2005. I have checked the web and have not been able to find any news regarding this. Do you know if the review took place? Another question I'm trying to get an answer for is whether our equipment is even considered "medical" by the EU. This equipment is used in hospital pharmacies to do things such as reconstitute drugs and mix nutrients in an IV bag.

    Any information you can provide me is appreciated.



    Dear Dave,

    The February 13, 2005 decision for medical equipment/devices is late, I don't know the status, we need to keep checking. I would be surprised if disposable medical devices are in the spirit of WEEE Annex IB's definition of medical devices. The compounding and pump equipment even farther off the mark. The WEEE definitions are below.

    An important point however, is that even if you are exempt from RoHS, you still have to register you products for WEEE in all 25 EU countries. How is that going?

    WEEE Definitions:

    Annex IB: 8. Medical devices (with the exception of all implanted and infected products)

    Radiotherapy equipment, cardiology, dialysis, pulmonary ventilators, nuclear medicine, laboratory equipment for in-vitro diagnosis, analyser freezers, fertilization tests, other appliances for detecting, preventing, monitoring, treating. alleviating illness, injury or disability.

    Best wishes,
    Dr. Ron