Then per Article 2 of REACH i.e. REGULATION (EU) No 528/2012,
- don't understand how REACH is applicable to medical devices. None of what we make matches the products listed in Annex V.
- My understanding is though CLP (and REACH too?) don't apply to finished med devices, since they are made of components that have chemicals in them, every finished device manufacturer is expected to do a risk assessment based on composition?
- if the above is true, are Annex VI table 3.1 of CLP and Annex V of REACH the lists to compare with?
Forgive me if this is a basic question, still trying to wrap my brain around this.
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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
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Original Message:
Sent: 09-Apr-2019 10:30
From: Sarah Ware
Subject: MDR CMR and Endocrine disrupting list
MDR refers to the classifications in CLP. If your product is a finished medical device (not a chemical compound) or an article, it is very unlikely the SDS requirements of CLP will apply.
The classifications from CLP roll into REACH. They are sister regulations in a sense.
1. Know the full composition of your products
2. Evaluate the substances against CLP/REACH Annexes
3. Determine your status based on your specific situation
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Sarah Ware
Minneapolis MN
United States
Original Message:
Sent: 09-Apr-2019 10:02
From: Vidyalakshmi Jayaraman
Subject: MDR CMR and Endocrine disrupting list
Thank you Sara. I'm a little confused about the applicability of CLP and REACH. Just saw another post where you say "CLP does not apply to medical devices. See Article 1 of 1272/2008/EC". We are device manufacturers and the devices we are trying to determine a path for CMR/endocrine testing are vascular access devices i.e. blood contacting implantables. We purchase many accessories to make our final device.
Does CLP not apply to us? Per GSPR of MDR, there is no such waiver.
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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
Original Message:
Sent: 09-Apr-2019 09:38
From: Sarah Ware
Subject: MDR CMR and Endocrine disrupting list
The REACH annexes are update roughly twice a year. You can't just "test" and say your product is ok. You need a holistic program to evaluate all the materials (including monomers, byproducts etc) that are in your product to make a determination, AND a program that re-evaluates to the new version regularly. Testing is normally only done for high risk substances based on the materials you are using.
If you need help establishing a program reach out to us.
Sarah Ware
Fang Consulting
Minneapolis, MN
612-230-9909
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Sarah Ware
Minneapolis MN
United States
Original Message:
Sent: 08-Apr-2019 14:39
From: Vidyalakshmi Jayaraman
Subject: MDR CMR and Endocrine disrupting list
Dear RAPS members,
In reference to MDR Annex I GSPR- Chapter 2, 10.4.1,
1. can you confirm this attached Regulation (EC) No 1272/2008 indeed has the list of CMR substances which our devices should be tested for?
Per Chapter 2, 10.4.4 of the GSPR
"Guidelines on other CMR and endocrine-disruption substances.
Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred to in Section 10.4.3 also for other substances referred to in points (a) and (b) of Section 10.4.1, where appropriate."
2. Are there currently any such guidelines on CMR/ endocrine substances available, at least drafts?
3. Is there a separate list for endocrine disrupting substances? because as per regulation EU 528/2012 mentioned in MDR Annex I GSPR- Chapter 2, 10.4.1:
"Pending the adoption of those criteria, active substances that are classified in accordance with Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.
Substances such as those that are classified in accordance with Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs, may be considered as having endocrine-disrupting properties."
meaning the endocrine list is a subset of the CMR list?
Any thoughts would be appreciated! Thanks.
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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
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