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May2021

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11 May 2021

CLP & In Vitro Diagnostic (IVD)

What applies?

CLP excludes from its scope in vitro diagnostic medical devices (IVDs) in finished form (Article 1(5)(d)). Does this mean that a hazard label according to CLP doesn’t have to be prepared for a product registered as IVD? Not exactly. The sector legislation (Directive 98/79/EC, replaced by Regulation (EU) 2017/746 from May 2022), provides that CLP labelling requirements fully apply and only in special cases hazard label elements can be omitted....
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