In June of 2011, the European Union published an updated and expanded version of the Restriction of Hazardous Substances Directive, which became effective on January 1, 2013. Until now, many American manufacturers haven’t had to worry about RoHS, either because they don’t sell products in the EU or because those products didn’t fall within the original scope of RoHS. But if you sell electrical or electronic instruments in the EU, it may be time to take a second look.
New products that will fall within the scope of RoHS
RoHS 2 expands the scope of products that must be RoHS compliant if they are to be placed on the market in the EU. While the list of new products is wide-ranging, medical device manufacturers in particular should look closely at the new requirements.
The following are a few examples of products that will fall under RoHS, if they are placed on the EU market:
From July 22nd, 2014, medical devices - monitoring and control instruments
From July 22nd, 2016, in-vitro diagnostic medical devices
From July 22nd, 2017, industrial monitoring and control instruments
Many other electronic and electrical instruments will fall within the RoHS scope in the coming years. The British Government has released a guide to the new requirements with a section explaining what products do and do not fall with under RoHS, which you can access here.
New documentation requirements
One of the major changes in RoHS 2 is the new requirement that manufacturers maintain compliance documentation. The new documentation requirements include:
Technical documentation describing the product, materials, parts and subassemblies
Supplier and materials confidence assessments
Supplier technical documentation of declarations of compliance and/or analytical test results
For manufacturers with existing quality documentation systems, it seems as though putting together the product documents required by RoHS should not be too difficult. The more tedious issue is collecting documentation from suppliers - yet another argument for using suppliers that already have recognized quality documentation systems - and better yet, suppliers that already have RoHS on their radar.
For a brief introduction to the new documentation requirements, check out the summary at BOMcheck.net here.
ROHS 2 Resources:
RoHS2 DIRECTIVE 2011/65/EU: What Manufacturers Need to Know and Do -- A thorough but succinct introduction to all the issues, with links to official sites and documents
The European Commission’s official RoHS 2 FAQ document. Not an easy read, but thorough.
The official text of the RoHS Recast Directive (or RoHS 2), from the Official Journal of the European Union.
Advanced Industrial Coatings is proud to provide RoHS 2 compliant coating services.
Information Policy Team. Department for Business, Innovation and Skills, (2013). Restriction of hazardous substances (rohs) regulations 2012(URN BIS/13/1142 ). Retrieved from Crown website: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/236285/bis-13-1142-restriction-of-hazardous-substances-regulations-guidance-2.pdf
BOMcheck.net. (2013, September 9). RoHS2. Retrieved from https://www.bomcheck.net/rohs
QNET, LLC. (2013, September 9). Rohs2 directive 2011/65/eu: what manufacturers need to know and do. Retrieved from http://www.ce-mark.com/RoHS2.pdf
RoHS 2: More Medical Instruments and Electronic Devices Fall Into Scope
by AIC Staff Writers, September 2013
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