;   Medical Translation Insight: EU hazardous materials regulation to cover medical devices - ForeignExchange Translations

EU hazardous materials regulation to cover medical devicesAfter a thorough "recasting" in the European Union, the EU's directives on Waste Electrical and Electronic Equipment (WEEE) and, especially, Restriction of Hazardous Substances (RoHS) will significantly impact the medical device field.

According to Massdevice.com, medical as well as in-vitro diagnostic devices had previously been exempted from the RoHS. Except for active implants, this exemption will not be extended in the next version. As a result, there will be important new considerations for component procurement, design, manufacturing, and support. Device manufacturers need to understand that obtaining exemptions is likely to become more complex as well.

The original directive has been in place since 2003.

As usual there will be a transition period. General medical devices as well as monitoring and control instruments (so-called category 8 & 9 equipment) will have three years to comply with RoHS following the directive's adoption; IVDs will get even longer (five years) to comply with "RoHS2".

From a medical translation perspective, the impact is likely to be limited. Labeling changes should be covered under the CE Mark requirements. However, some manufacturers may add additional visual indicators such as "RoHS compliant" labels, green leaves, check marks, "PB-Free" markings, or the closely related WEEE trash-can logo to indicate compliance.

To learn more about the rationale for the WEEE/RoHS Directive, how these directives relate to other legislation (e.g., EuP), and why complying with the RoHS directive may not be straightforward, take a look at WEEE and RoHS Revisions: Implications for Medical Device Manufacturers.

With the final step to approve legislation in the Council of the European Union "very near", we'll be sure to provide further updates.

[Hat tip to Emergo Group]

Link to Directive 2011/65/EU [PDF].

ForeignExchange Translations provides specialized medical translation for regulatory affairs groups at medical device and pharmaceutical companies. Contact us to learn more.


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