Update: RoHS 2 Deadline for July 22, 2014

08 Jan 2014

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:

• Blue Guide to the implementation of directives based on the New Approach and the Global Approach
• A Practical Guide to understanding the specific obligations of Directive 2011/65/EU" that is available for download at the ORGALIM.EU website.

What other questions do you have regarding this topic? Please leave your comments below and one of our experts will get back to you.