Hi Nadine,
EU RoHS compliance is applied at the product level and is compulsory for gaining CE mark in the EU for electrical and electronic equipment (ie. yes you need to be RoHS compliant before you can sell to the EU). If your medical device is not EEE, then RoHS does not apply. The newest list of an additional 4 Phthalates substances has an implementation date of July 22, 2021, but the other 6 substances are already in force. The RoHS Directive is not linked to the MDR. EU RoHS is a Go/No-Go situation - if any homogeneous component of your product is over the threshold limit allowed, you are not compliant, you can not claim a CE mark, and you therefore can not sell to the EU. Separate labeling (like IFUs) and packaging are exempt from RoHS.
EU REACH is different in that it is not a Go/No-Go situation. You can have components over the threshold limit, and as long as you have met the obligations that are triggered, then you can still ship products into the EU. EU REACH is not tied to the CE mark. It is coincidentally tied to the MDR in that there are some overlapping Hazardous Substances requirements from section 10.4. Also, REACH is different than RoHS in that it is tracked by substance, not by product. Meaning, you could have 10 medical devices with Formamide in them over the threshold limit and will still be able to ship them to the EU, but you need to keep track of the cumulative tonnage you are shipping into the EU per year, per legal entity. More than 1 tonne/yr will trigger another obligation - registration. And one more thing, EU REACH is also not limited to EEE - anything, ANYTHING, you ship into the EU needs to be evaluated for REACH obligations, including labeling, packaging, etc.
This is a way over-simplification of REACH because I don't want to scare you lol! But there is a lot dependent on the types of things you are shipping (articles vs. substances/mixtures), whether the substance is released into the air, your supply chain tracing (where components are manufactured), your role in the supply chain (importer, EU manufacturer, down-stream user, etc.), substance use, on and on...
If you can get more specific about your products, I can help direct you further. Feel free to message me directly!
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Rene' Hardee
Regulatory Affairs Manager
Marlborough MA
United States
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Original Message:
Sent: 04-Feb-2021 17:16
From: Michael Hottner
Subject: RoHS compliance for medical device in Europe
Dear Nadine,
RoHS is not directly linked to the MDR.
The RoHS Directive 2011/65/EU is a separate precondition to be met for CE marking, in case it applies to your product (electronic devices).
RoHS2 needs to be applied already by today, the transition period for RoHS3 ends on July 22nd 2021.
WEEE applies to medical devices as well in case they are considered 'EEE' (electronic). Check out the definition of 'EEE' in 2019/12/EU. There are exceptions for implantable and infected medical devices.
REACH applies to any product sold in the EU. It is really complex (after ten years of dealing with environmental compliance I still just understand the basics necessary for medical devices and not the entire regulation). Here is a pretty good summary:
https://www.mddionline.com/regulatory-quality/reach-faqs-medical-device-professionals
There is a small overlap between REACH and MDR GSPR #10.4 Hazardous Substances. But I recommend to evaluate both topics separately since REACH applies to any product and GSPR#10.4 only to invasive devices or devices for administration.
Cheers,
Michael
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Michael Hottner
Köln
Germany
Original Message:
Sent: 04-Feb-2021 14:47
From: Nadine Adia
Subject: RoHS compliance for medical device in Europe
Dear all,
This is new for me and I need your advise please.
RoHS stands for Restriction of Hazardous Substances, and impacts the entire electronics industry and many electrical products as well.
Since 2014 the substance restrictions of the RoHS Directive have been applicable to medical devices.
Is this applicable all medical device without active medical device?
is it mandatory to demonstrate the compliance with the requirements of the EU's RoHS 3 before selling in Europe?
I don't see this requirement into the new MDR.
Could I say that the REACH, WEEE are also apply in the same way.
Thank you in advance for your help.
Rgds,
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Nadine Adia
Quebec QC
Canada
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