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Medical Devices CLP Regulation

#1
Where to find specific requirements and rules stating when a product CLP review is recommanded or necessary!?

Noting that, a Safety Data Sheet "Section 2 - Hazards Identification/CLP" depends principally on all CLPs of individual components formulating the finished product.
Hence, further to any change/update of one component CLP, it's mandatory to accordingly update the SDS/CLP of the finished product(s).
However, in case of multiple finished products, where the same component is used, shall we update all finished products CLPs/SDS!? This is really time and money consuming! Moreover, this must be done by Expert Toxicologist .... consultation..!!
So looking for assistance, if perhaps we can define internal process of review or maybe periodically ... ; for example review each 2 or 3years of all Products CLPs!
Otherwise, it won't be easy to assess the impact of a component CLP change on the CLP of the finished product CLP, without a full review.

Kindly assist! thanks!
 
Last edited:
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planB

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#2
Brian,

in case you are referring to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation): no there is no specific requirement for medical devices that you have to perform the kind of review you are describing above.

What you do have to do is to demonstrate that the device is biocompatible for its intended use, and maintain its biological safety as long as you put the device on the market. In this context a periodic SDS review may or may not support this activity, since there is no direct link between SDS information and biocompatibility: SDS have mainly been developed in the context of occupational safety, i.e. help the user of chemicals and mixtures to not get harmed or harm others (including the environment) when handling the affect substance (mixture).

Another possible approach: define in your supplier contract that your suppliers have to notify you in case the SDS changes in content.

Have also a look into (EC) No 745/2017 (MDR, Medical Device Regulation), Annex I, chapter II, section 10.4 about substance requirements specific for medical devices.

Hope this helps,
 
#3
Hi B,

Thanks a lot for assistence!

Yes you're right, biocompatibility work is in progress as a main task that must be achieved as you mentioned!

In your above clarification, yes you raiseded up the most important point "to define in the SQA Supplier Quality Agreement", the supplier must inform us in case if any changes in CLP contexts, afterwards an internal process for review can be drafted with a specified coverage interval.
Otherwise, it won't be easy to have a full control, the process is here the important point. We should also keep attention that CLP texts as a basis of SDSs review, should be also printed on products Printed Matters (Box, Instruction, ..).

:bighug:
 
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