Medical to Fall Under RoHS Scope in 2014

If you think RoHS is in your rear-view mirror, think again. A significant electronics market is going to feel the impact of RoHS within the next few years and may be caught unprepared.

Medical devices will fall under the RoHS scope starting in 2014, according to Gary Nevison of Newark/element14. Medical devices have so far been exempt from RoHS because of the critical nature of the devices and the necessary use of hazardous materials such as lead to protect users from radiation.

Medical devices fall under its regulations in 2014 but the sale of non-compliant devices into the EU won't be halted until 2019.

The manufacture of medical devices is still a very tightly held business. It is highly regulated, and it is difficult to quality for the various approvals required by law. Medical electronics companies have also been slow to outsource manufacturing, preferring to retain quality control in-house. Now that medical falls under the RoHS, it is likely the industry will experience many of the same issues the broader electronics industry has in terms of interpreting and implementing RoHS.

Nevison noted of a recent meeting in Belgium:

    During the meeting it was confirmed that passenger lifts will be considered large-scale fixed installations and would therefore be excluded from the scope of the RoHS Recast. It was also recommended to exclude pipe organs and electric bicycles from scope in the future. However, petrol engine powered garden equipment and toys with secondary electrical functions are expected to fall within scope.

    While no change to the definition of homogeneous material was deemed necessary further clarification was requested on both thin coatings and CrVI passivation coatings.

Medical equipment companies can continue to ask for exemptions to the rule.

5 comments on “Medical to Fall Under RoHS Scope in 2014

    June 5, 2012

    I found the categories mentioned from the Beligian meeting to be quite arbitrary.  I can understand the reluctance to overregulate medical but garden equipment?

  2. Barbara Jorgensen
    June 5, 2012

    @SCOT: I hate to sound anti-politically correct, but I do think there is a point where regulation–even in environmental matters–can go to far.

  3. garyk
    June 6, 2012

    The Medical Industry should talk to the Military/Defense Industry for advice and comments. RoHS componets are OK for Phones and other electrics devices that only going to be used for 2-5 years before they get up graded. Tin Whiskers might take longer to short out these devices. I am not sure about the Medical devices. We need to stop listing to Europe and these Lead issues. Maybe we should evaluate all Lead reclaim that contaminating various places in CHINA!

  4. GN
    June 7, 2012

    Just for clarity all these issues are still under review, including Article 2.2 and its definition of “making available on the market”. This will apply to all relevant product categories, not just medical. In terms of gardening equipment this was discussed as part of the EC 3rd stakeholder workshop. Because of the ban of lead in solder used in gardening equipment an enviromental benefit is expected. We will have to wait for Government Guidance and the important FAQ document that will help guide industry. Unfortunately the latter was originally expected in June but has now slipped to October.

    Gary Nevison


  5. Barbara Jorgensen
    June 7, 2012

    Hi Gary–thanks for the additional information. As always, you are the resident expert on all things RoHS (and WEEE and REACH and…) Quite a responsibility


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