Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
When is RoHS 2 compliance required for declaration of CE Mark?
Is RoHS 2 compliance required for declaration of CE Mark? The answer to this question all depends on whether the repaired, upgraded or refurbished device is placed on the market as 'used', 'pre-owned' or 'refurbished' or as 'new.'
Medical devices that were placed on the European market before the entry into force of RoHS restrictions, once repaired, upgraded or refurbished do not need to be RoHS compliant as long as the medical device is made available as 'used', 'pre-owned' or 'refurbished.' If the used medical device is made available as 'new,' it now is viewed as being placed on the European market for the first time and is required to comply with RoHS 2 and all applicable RoHS 2 requirements as of that date. Making available a used medical device as "new" is equivalent to placing it on the market.
After July 2014, equipment placed on the market outside EU for the first time cannot be imported and placed on the EU market as second hand or refurbished unless it is RoHS compliant.
Additional guidance documents that may help answer your questions include:
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Today's expert is Joe Langton, Business Service Line Leader within Intertek's Chemical unit. For the past five years, he has provided comprehensive compliance solutions related to the RoHS Directive, Restricted Substances, CPSIA, REACH, End of Life Management and Electronics Recycling, Environmentally Preferable Materials, and California Proposition 65. Joe is based out of the Allentown, Pennsylvania office.