In just one year, on the 22nd of July 2014, the RoHS Recast Directive for manufacturers and importers of medical devices will become law and all devices must be compliant or lose their CE mark.

It is hard to believe that it has been eleven years since Europe exported the RoHS Directive and the TV show American Idol to the United States.  I find it interesting that over a decade later both are being re-branded to reach new markets and objectives.  American Idol recently leveraged its loyal base of followers to successfully spawn the new hit show the X Factor and the RoHS Directive, well let’s just say it has been on a different journey.

Way back in 2002 the Commission of the European Union (EU) passed legislation
restricting the use of hazardous substances in electrical and electronic equipment (RoHS Directive 2002/95/EC) and promoting the collection and recycling of such equipment (WEEE Directive 2002/96/EC). The legislation provided for the creation of collection schemes where consumers can return their used e-waste free of charge with an objective of increasing recycling and/or re-use of such products.  The law also required heavy metals such as lead, mercury, cadmium, and hexavalent chromium and flame retardants such as polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE) to be substituted with safer alternatives.

Many careers in the research, design engineering, and manufacturing industries had yet to start and they have known no other standard.  The rest of us remember the controversy and news coverage documenting that after four years of regulation only about a third of electrical and electronic waste was compliant and illegal trade of the materials had increased, as had the environmental and health risks.  More troubling was the findings that many electrical and electronic products in the EU market did not comply with the substance restrictions and that they were difficult to enforce by market actors and public authorities.

So in December 2008, the European Commission proposed to revise the directives on electrical and electronic equipment as a means of increasing the amount of e-waste that is appropriately treated and to reduce the volume that goes to disposal. The RoHS recast also included provisions to reduce administrative burdens and ensure coherency with newer policies and legislation covering, for example, chemicals and the new legislative framework for the marketing of products in the European Union. The RoHS Recast Directive was published in the Official Journal in July of 2011 for public review and becomes law on January 3rd, 2013.

The RoHS Recast Directive replaces the original RoHS Directive (2002/95/EC) and broadens the scope to include medical devices, in-vitro diagnostic medical devices, and industrial monitoring and control equipment. Both the manufacturer and importer are legally responsible for compliance and the staggered compliance deadlines for the newly included equipment types are:

• July 22, 2014—Medical devices
• July 22, 2016—In-vitro diagnostic medical devices
• July 22, 2017—Industrial monitoring and control equipment
• July 22, 2019—Electrical and electronic equipment formerly outside the scope of the Directive

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So what does that have to do with medical devices manufactured in the US?

If you manufacture medical devices that are distributed in the European Union, or ever foresee this as a possibility, then you must also be compliant with the RoHS Recast Directive.

The List of Restricted Substances:

• Lead (Pb)
• Mercury (Hg)
• Cadmium (Cd)
• Hexavalent chromium (Cr6+)
• Polybrominated biphenyls (PBB)
• Polybrominated diphenyl ether (PBDE)
• note: maximum concentrations remains unchanged from the original RoHS Directive

However, future additions to the list remain likely.  The COR committee report expressed regret for the exclusion of brominated flame retardants, chlorinated flame retardants, PVC, chlorinated plasticizers, DEHP, BBP and DBP as restricted substances.  Please be advised that the restricted list is subject to review by July 2nd, 2014 and there have been some reports that the United States is considering similar measures.

Manufacturer responsibilities include:

• Creation of technical documentation that will demonstrate compliance with Annex II (768/2008/EC)
  • Please note that failure to provide an EU technical file upon request by a national authority is a compliance violation
• Implement internal production control procedures
• Keep a register of nonconforming products
• Draw up Declaration of Conformity
  • DoC must be in the language of the local market (EN 50581)
• Attach the CE mark to the finished product
• Mark product with manufacturer’s name, trademark, contact address and a type, batch or serial number (to facilitate recalls)

Importer responsibilities include:

• Creation of technical documentation that will demonstrate compliance with Annex II (768/2008/EC)
• Ensure manufacturers comply with obligations listed
• Retain a copy of EC Declaration of Conformity
• Indicate their name and address on the EEE or where that is not possible on its packaging or a document accompanying the EEE
• Keep register of non-compliant EEE and EEE recalls

Basic recommended RoHS Recast Directive compliance approach:

1. Scrub Bill of Materials (BOM) immediately
2. Perform XRF chemical screening of components
3. Compile Technical Construction File (TCF)
4. Conduct risk assessment of materials and/or manufacturing processes
5. Update quality system to include RoHS compliance processes

The EU Commission has launched a website to support the RoHS Recast Directive during this transitional period, which provides news updates as well as links to supporting documents and information.  It is highly recommended that you immediately start researching the new law, appoint an internal dedicated owner for this initiative, and consider supplementing your efforts with outside partners to acquire additional expertise and support resources.

About the author: Rod Cain is a practicing strategic marketing professional at RBC Medical Innovations, who previously helped support the development of profitable new market share for Samsung, Rodale, and Meredith.