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. Originally published in April 2016, the article is updated on March 2, 2021 to include more details on the July 22, 2021 deadline. 

RohsRoHS 3 – The Trilogy is Complete

Are your medical devices RoHS compliant?

The Restriction of Hazardous Substances (RoHS) Directive has had a substantial and permanent effect on the materials that go into many of the electronic products we make.

The original RoHS legislature (2002/95/EC), was released in 2002, and it restricts the amount of six substances (the first six on the list below) to only trace amounts in Electric and Electronic Equipment (EEE). In 2011, RoHS 2 (formally known as directive 2011/65/EU), replaced the original RoHS 1 legislature, by updating the scope and applicable types of products. Then, RoHS 2 was given a substantial update in the form of Delegated Directive (EU) 2015/863 to add four new substances and become what is colloquially known as RoHS 2.1 or RoHS 3 (they are the same thing).

Are your medical devices compliant with the latest changes?

RoHS 3 (EU 2015/863) expands the list of prohibited substances from six to ten by adding four new types of phthalates. This directive has been adopted by the EU legislature and came into full force on the 22nd of July 2019 with a special provision for medical devices until 2021 (see below for details). The final list of substance 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 that were added in RoHS 3 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 Plexiglas) plastic.

How does RoHS compliance pertain to medical devices?

Interestingly, medical devices have special rules for these four substances:

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 (i.e., 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.

Therefore, spare parts only need to comply with RoHS 3 for medical devices placed on the market after 22 July 2021.

If you haven’t done so already, I would highly encourage designers to source materials and components that are RoHS3 compliant right away – it’s the law. 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.

Image: 2641435 © Wayne Ruston | Dreamstime.com

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.

 


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13 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
    John

  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.

    http://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32015L0863&qid=1499273927968

    Thanks,
    Nigel

  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:

    Michael,

    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!

  8. Chris says:

    Hello Good Evening,
    I would like to know, is 370HR Material is falls in category of RoHS 3 Compliance Material?
    Please Advise.

  9. Most vendors supply this information for their specific formulation, especially for electronic components like this – I’d suggest getting in contact with your vendor! If they can’t, you may want to move on to another vendor who can. If this is not possible, a close review of the directive can help you understand exemptions and risks for this family of materials.

  10. Aaron says:

    if my product was complied with REACH and ROHS 2 requirement, is that possible I can claim it is complied to ROHS 3 as well since the 4 new added banned substances are on the REACH list of SVHC

  11. Hi Aaron – if the product is listed as having no SVHCs, and indicates REACH compliance with a SVHC list that includes those 4 substances (as the SVHC list is updated frequently), then your thought process seems reasonable. The only thing you may want to double check is if there are any exemptions that apply under REACH but not RoHS. Similarly, I’d suggested double checking that there are no exemptions for the other 6 materials that applied under RoHS 2 but don’t apply under the latest version of RoHS. Lastly, and this is getting complex, but RoHS and REACH are applied at the sub-component level differently, so there may be some misalignment there. Overall, it’s not quite so simple as you might hope and your method could work, or it might just be easier to get updated information.

    Thanks,

    Nigel Syrotuck
    Mechanical Engineering Team Lead

  12. Norma says:

    How does USP Class VI relate to RoHS for Medical Lab equipment

  13. Nigel Syrotuck says:

    Hi Norma,

    USP Class VI is related to biocompatibility, whereas RoHS is an environmental regulation. There might be a bit of overlap in that many chemicals that are bad for human contact are also bad for the environment, but otherwise they are two completely different things.

    Thanks!

    Nigel Syrotuck

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