Nigel Syrotuck

RoHS 2 vs RoHS 3 impact on medical devices

Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate.

RohsRoHS 3 – The Trilogy is Complete

The Restriction of Hazardous Substances (RoHS), has had a substantial and permanent effect on the materials that go into many of the electronic products we make.
RoHS 2 (formally known as directive 2011/65/EU), which is the current version, restricts the amount of six substances (the first six on the list below) to trace amounts in Electric and Electronic Equipment (EEE). It replaced the original RoHS 1 legislature (2002/95/EC), which was released in 2002, by updating the scope and applicable types of products.

Last year, RoHS 3 was announced, which expands the list of prohibited substances from six to ten by adding four new types of phthalates. This directive has already been adopted by the EU legislature, and member states have until December 2016 to inform suppliers how they are required to meet the standards of RoHS 3. Suppliers then have until the 22nd of July 2019 to meet these provisions. The new list is as follows:

  • Lead (0.1 %)
  • Mercury (0.1 %)
  • Cadmium (0.01 %)
  • Hexavalent chromium (0.1 %)
  • Polybrominated biphenyls (PBB) (0.1 %)
  • Polybrominated diphenyl ethers (PBDE) (0.1 %)
  • Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %)
  • Butyl benzyl phthalate (BBP) (0.1 %)
  • Dibutyl phthalate (DBP) (0.1 %)
  • Diisobutyl phthalate (DIBP) (0.1 %)

The 4 new members of the party are all phthalates that are used as plasticizers, and are thankfully already banned or restricted in many parts of the world. DEHP accounts for a more than half of the plasticizer industry, for example making up 60% in the Asia Pacific market. It is also heavily prevalent in PVC, which for this reason and others is quickly becoming an unwise choice of plastics in the design of EEE. BBP is widely used in vinyl floor tiles, but can also be found in caulking and adhesives. DBP can also be used in adhesives and in inks. DIBP is used in making PMMA (commonly known as acrylic or plexiglass) plastic.

Interestingly, medical devices once again have special rules:

The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.

Medical devices, therefore, have until 22 July 2021 to comply with RoHS 3 (rather than 22 July 2019). Note that medical devices are already required to comply with RoHS 2. Lastly, we get to the big question: what about your existing products?

The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019…

So current devices in the field will be exempt as far as spare parts (ie, cables) are concerned, but EEE sales after 22 July 2019 will need their spare parts to comply with the directive.

…and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.

Similarly, medical devices have an extra two years for compliance.

Though 2021 seems like a long way away, products released today would only be able to stay on the market for 5 years without being re-evaluated and potentially redesigned.  For this reason and because REACH is also looming, not to mentioned harmful and unsafe nature of these chemicals, I would highly encourage designers to phase out materials with these chemicals sooner rather than later.  Knowing what to look for and finding good vendors with appropriate quality programs will lead to a smoother product development program and faster time to market.

Nigel Syrotuck is a StarFish Medical Mechanical Engineer.  He works on projects big and small and blogs on everything in-between. This is his first RoHS blog for StarFish Medical, but not his last.

© Wayne Ruston | – A RoHS Sign


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7 responses to “RoHS 2 vs RoHS 3 impact on medical devices”

  1. John Holland says:

    Hi, I respectfully suggest you might want to revisit the list
    • Mercury (Hg): < 100 ppm (0.01%)
    Kind Regards

  2. Nigel Syrotuck says:

    Hi John, thanks for taking the time to leave a comment.

    Despite what appear to be typos on a number of unofficial websites, I can’t find any references to Mercury being limited below the standard 0.1% in the legal text from the EU. Unless there is a more updated directive or amendment I’m not aware of, the original legal text at the link below confirms that mercury is allowed up to 1000ppm in EEE (see Annex II). Let me know if you have other information to the contrary and I’d be happy to update this article.


  3. Delegated Directive 2015/863 amends the RoHS 2 Directive, 2011/65/EU. It is NOT a NEW RoHS Directive, so it is NOT “RoHS 3”. Article 24(2) of 2011/65/EU defines when the next recast of the RoHS Directive will occur. That will officially be “RoHS 3”. Stop using this colloquial term; it simply creates confusion. Thank you.

  4. Nigel Syrotuck says:


    Great point. I was following the colloquialisms of others here, but you’re technically correct. I’ll add a note to the top of the article clarifying.

    Thanks for reading!

  5. Andrew says:

    Pretty much all of our 450 suppliers referred to Directive 2015/863 as RoHs 3 so “RoHs 3” is here to stay and consecutive directive will become RoHs 4 🙂

  6. DJ says:

    Does “RoHS 3” pertain to UL certified labels and inks? Are there exemptions to labeling materials?

    Pthalates are common in adhesives and inks and it appears difficult to find labels claiming RoHS 3 compliance. Most claim RoHS 2. Still searching.

  7. Mike Camplin says:

    Nigel Advises: That is certainly a commonly asked question. I think the answer that will be the most helpful is that you should be sure to remember that “RoHS 3” is a colloquialism – it’s actually amendment (EU) 2015/863, to the RoHS 2 Directive (2011/65/EU), so perhaps your vendors are claiming the right conformance. To answer your direct question: as far as I know, there are no exemptions for labels of any kind, so you would have to find a supplier who can certify that the ink and the substrate are both compliant, unless you consider them homogenous (unable to be separated mechanically), in which case you may not need to consider the ink if it’s less than 0.1% (0.01% for cadmium) of the weight of the label. Generally I find it easier to work with a supplier who provides the right certifications than try to estimate or measure weights – those suppliers do exist!

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