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The Tyranny of RoHS: Understanding and Avoiding Pitfalls for Medical Devices and Monitoring/Control Instruments

12.09.2013 // Mike Kirschner // Supply Chain

Over the next few years manufacturers producing medical devices or monitoring and control instrumentation will need to bring their products into compliance with the EU RoHS directive, as they are in Category 8 or Category 9 respectively, of the scope. In this article I will discuss some of the “lessons learned” by the other eight categories (1-7 and 10) as well as the implications of being “late to the party”.

Complying with RoHS today from a dead stop should generally be a far easier task than it was for manufacturers a decade ago, when it was entirely new. Today the supply chain has almost entirely converted to RoHS compliance to such an extent that it has become quite difficult to produce a non-compliant product…as long as that product is within the original scope of the RoHS directive.

Products in Categories 8 and 9 are, in fact, often quite different from the rest of the categories both in terms of customer base and, more importantly, supply base. While there is certainly a good degree of supply base overlap, particularly in the standard off-the-shelf components and technologies used by medical devices and instrumentation products, there are segments of the supply base that cater to the often very complex and technically demanding – not to mention low volume – properties of these products. They, as well as your own internal team, may not have nearly the knowledge and expertise of RoHS that the mainstream electronics supply chain does.

So let me give you some pointers.

First, read the Directive thoroughly and understand its requirements. Among them:

  • There are substance restrictions; you cannot use these substances in your product above the maximum concentration values defined in the Directive unless there is an applicable exemption available that you can claim. See below.
  • You probably have not specified these substances; a supplier upstream in your supply chain did and you may not be aware of their presence.
  • You have to find out if any of the restricted substances are in your product. So you need to inquire back upstream to find out. How do you do this? I will address this below.
  • Don’t panic; there are exemptions defined in Annex III and IV that your product can use. Make sure you know whether your suppliers are using any of those exemptions and, if so, which ones. Exemptions expire automatically seven years after your products come into scope. But see below.
  • You have to declare your products’ compliance via the CE Mark. This means you need to have control over your supply chain, and documented evidence of both that control and your products’ compliance. Consider using harmonized standard EN50581-2012 for that purpose.

Second, set down the rules for your suppliers and your engineers. Define your requirements:

  • All parts and materials you are, and will be, using must comply with RoHS.
  • Suppliers must verify to you that they understand how RoHS requirements for your products relate to their products.
  • You may have to provide a degree of training for your suppliers that do not understand this. Focus on suppliers of your custom items.
  • Suppliers must demonstrate compliance of the products they sell to you, either through adequate and validated control over material selection and management or through providing test results over time, or perhaps a combination.
  • Engineering must use only compliant parts and materials to design products.
  • Both suppliers and your internal engineering group must understand the Annex III and IV exemptions; if an exemption is required for compliance it must be identified and recorded.
  • This requires a degree of control over the supply chain and product development you may not have in place already (particularly for Category 9 products; US FDA and European Medical Device Directive requirements, for instance, already require a solid framework to be in place for Category 8 products but do not address RoHS-related requirements).
  • Since I’m writing this for a component distributor’s website, understand that you may have to consider TTI (and other distributors) to be a supplier that needs qualification too. When you do not specify a particular manufacturer and manufacturer’s part number, but instead specify a technical requirement and leave fulfilment of that up to the distributor, you are forcing the component distributor to select parts – and manufacturers – that must be in compliance with the RoHS Directive’s requirements. Be sure that the distributor can do that; you may have to assess and qualify them for their ability to do so. While this should not be a significant challenge with an authorized distributor of name-brand and well-known passive components like TTI, historically the greatest challenges have been with distributors of fasteners and hardware.
  • A similar situation may occur with Contract Manufacturers. To the extent that they select materials like solders, adhesives, and even printed circuit boards, they must have solid supplier selection and management systems in place in order to validate the RoHS compliance of the materials they select on your behalf.

Third, understand just how little control you really have over the Annex III exemptions, and how little they really mean to you.

  • These exemptions may expire between 2021 and 2024 for your products (depending on the date your product comes within the scope of the RoHS directive).
  • Note that they expire in 2016 for the mainstream electronics industry, unless an application for extension is provided to the European Commission and is accepted.
  • There are quite a few exemptions that will be eliminated in the interim, at least for use by products from the mainstream EEE industry (categories 1 through 7 and 10).
  • There are some the mainstream EEE industry can be expected to apply to keep.
  • Just because your use of these exemptions is allowed past 2016 does not mean that parts/components/materials will actually be there for you to use. Think of this as “the tyranny of RoHS”: Category 8 and 9 products do not drive mainstream technology; they follow. Components using these exemptions will become obsolete and availability will suffer as the mainstream moves away from them.
  • Any time non-mainstream EEE manufacturers use mainstream components or technology they risk a mismatch of product lifecycles. I worked on products that were manufactured for upwards of 5 years, and were to be supported for 20, but we had to use fairly mainstream DRAM technology. Balancing prediction of the future with inventory is a very tricky job. This aspect of RoHS will complicate the situation even more than normal for Category 8 and 9 manufacturers since the scope of components and technologies using exemptions is far broader than components used by high volume consumer applications.

Fourth, get a database.

  • You will need to manage and maintain a huge and ever-increasing amount of data in order to comply with RoHS (and REACH, and battery requirements, and packaging requirements, etc. in the EU and in other markets around the world).
  • Collecting PDF forms from suppliers, while perhaps adequate for verification purposes, does not provide you with the ability to find, for instance, all suppliers providing parts using a specific exemption that may expire for the mainstream in 2016 so you can ask them, proactively, whether you should be considering a replacement part or technology.
  • There is an industry standard approach for collecting material composition data, IPC 1752A, but it requires that you have computer systems and databases capable of comprehending and using the XML (eXtended Markup Language) format. There is no human-readable form provided as part of this standard (though some tools exist that allow you to view them on an individual basis).
  • Manually putting together Technical Documentation for all of your products, each with thousands of components, will be a significant burden for your document control, quality, compliance and engineering departments.
  • Don’t try to create a custom solution in-house. There are a wide variety of approaches and tools available in the market already. Maintenance and capabilities in an environment of constant and increasing regulatory and customer-driven change should be important considerations, among others.
  • Human interaction with data introduces errors. Always. We are imperfect beings. I’ve probably made typos and grammatical errors in this article. Try to minimize human interaction between your suppliers’ provision of compliance information and your system’s management of it.

In this short article I’ve been able to hit only a few of the issues I’ve seen and experienced helping companies comply with RoHS and other substance-related requirements. There are many more.

As always, please contact me if you have any questions, comments or observations you would like to share.

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Statements of fact and or opinions expressed in MarketEYE by its contributors are the responsibility of the authors alone and do not imply an opinion of the officers or the representatives of TTI, Inc.

Featured Contributor:
Mike Kirschner

Mike Kirschner

Mike Kirschner is a product environmental compliance and performance expert who provides advice and expertise to manufacturers in a variety of industries. His primary areas of focus include EU RoHS, the impact of EU's REACH regulation on article manufacturers, California’s Safer Consumer Products regulation, and performance standards like IEEE-1680.x for electronics. Mike helps manufacturers define, implement and troubleshoot internal management systems that result in compliant products, and assesses and monitors environmental regulations around the world on their behalf. ( More... )

He contributed two chapters to the Governance, Risk, and Compliance Handbook, published by Wiley in 2008, and is featured in the critically acclaimed book, Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power. In 2009 he was appointed to the California EPA Department of Toxic Substance Control's Green Ribbon Science Panel. Prior to joining ENVIRON, Mike founded product lifecycle and environmental consultancy Design Chain Associates, LLC (DCA), where he served as president and managing partner. Before founding DCA in 2001, Mike spent 20 years in engineering and engineering management roles within the electronics industry with manufacturers including Intel and Compaq. He holds a BS in electrical engineering from Worcester Polytechnic Institute.

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