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IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks?



Hi All,

A discussion has come up with our HS&E officer on the hazard labelling of products and information we need to show on primary, secondary and within the IFU.

He, naturally, refers back to the CHiP and "new" CLP regulations and states that we must show the symbols, phrases, and then supplementary statements etc. etc.
We are including all relevant symbology and information on the outer packaging and in the IFU however due to the size of our products there is no feasible way of doing this on the primary labelling without using the peel/fold labels - which are accounted for in the regulations and he says that we must use them going forward.

Essential Requirement 8.3 of the IVDD states

In the case of devices containing or a preparation 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 danger symbols and labelling requirements of Directive 67/548/EEC (1) and
Directive 88/379/EEC (2) shall apply. Where there is insufficient space to put all the information
on the device itself or on its label, the relevant danger symbols shall be put on the label and the
other information required by those Directives shall be given in the instructions for use.

The provisions of the aforementioned Directives on the safety data sheet shall apply, unless all
relevant information as appropriate is already made available by the instructions for use.
This "get out clause" is still included in the upcoming IVDR, and makes explicit reference to the CLP regulation.

My question is, does this 'get out clause' entirely outrank the requirements of the relevant hazard labelling regulations?

Many Thanks


Ron Boumans

Don't use that 'get out clause' too easily!

Be pragmatic: sometimes devices or parts are just too small to put symbols on them. Even the packaging of parts can sometimes be too small for practical use for symbols. In those cases we usually see a bulk packaging with enough space for clear warnings and information. But it also happens that most of the space on a label or device is taken for logo's and commercial information ("New design!") That is - of course - no excuse for leaving the warnings off the label.

Besides, there is allways the risk analysis. If there is a risk identified that should be addressed by a warning, that warning should be placed on an appropriate location so that the user can get this information at a relevant moment. And that is exactly what essential requirement 8.3 of the IVDD is about.
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