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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.

Annex I, Chapter III, Section 20.1. (i)) of the IVD Regulation reads:

               “The label shall bear all of the following particulars:

(i) In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use.”

Moreover, according to the CLP labelling requirements, the lack of space on a label cannot be justified with the need for translation. More languages than those required by the Member State(s) where the product is placed on the market can be used, provided that the same information appears in all languages used (CLP Article 17(2)) and that the label still fulfils the requirement of being easy to read (CLP Article 31). The ECHA Guidance on CLP further clarifies that the labelling exemptions for small size packaging are not allowed if a label becomes unreadable only because the supplier wishes to add more languages than required. (see Section 5.3., page 46).

The hazard information that needs to appear on the label of a hazardous substance or mixture is listed in CLP Article 17. In addition, the mandatory supplemental labelling information must be provided e.g. the REACH authorisation number, if an authorisation was granted.

Other CLP provisions than the labelling requirements, such as the notification to the Classification & Labelling inventory maintained by the European Chemicals Agency or the notification of hazardous mixture to the Poison Centers, do not apply to IVDs. However, please be aware that there are Member States that require the notification to Poison Centers also for IVDs under the national legislation.

If you need support in designing labels for your IVD products, ALSTER would be glad to advice you.