The following questions were submitted to, and answered by, Dr Paul Goodman of ERA Technology about meeting compliance requirements in the EU:
Q. I'm wondering about existing product that may be sitting in our warehouse in EU and meeting the RoHS compliance date. In particular, if we have medical devices in the EU, which are currently not subject to RoHS. A couple of those product lines are slow moving. If we have material in a warehouse in the EU, and it is not yet sold to a final customer, could we still sell it after the compliance date? Some of these may have single digit unit sales per year or, would we be prohibited from selling these products.
A. The requirement to comply applies only to equipment placed on the EU market after mid 2014 (i.e. imported into the EU or manufactured in the EU for sale) as this is when we expect medical devices will be included in scope of the RoHS (recast) . So there is no problem selling older non-compliant medical devices after the deadline as long as you have records that show when they were placed on the EU market (e.g. dates and serial numbers).
Q. Also, what about the CE mark issue? We could have existing product in the EU without the RoHS compliant aspect of the CE mark, next to redesigned product that is compliant in the warehouse. After the compliance date, would we be prohibited from selling the older product?
A. No because they were put onto the market before the deadline for compliance. The non-compliant versions and the compliant versions will be different products with different model numbers possibly, and will need separate DoCs and technical files.
Q. If we had older product after the compliance date, and we could still sell the older product that is in the EU, would we still be able to ship across country borders, ie a warehouse in The Netherlands and shipping to Italy?
A. Yes, because RoHS is a single market directive.
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