Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

CLP – 1272/2008 Classification, labelling and packaging of hazardous substances regulation

 Regulation – Published 16 December 2008 • Managed by ECHA • Article 1, 5d states IVDs are exempt • IVDR Annex I, Chapter II 10.3 references the need to design devices to reduce risk posed by substances in part 3 of Annex VI of CLP • IVDR Annex I, Chapter III 20.1(i) states that of required pictograms and labelling requirements of CLP shall apply

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CLP – 1272/2008 Classification, labelling and packaging of hazardous substances regulation

Labelling of IVDs

• 1272/2008 amended REACH, SDS must comply with CLP incorporating pictograms, H&P statements • Labelling of IVDs must use pictogram at least, full information e.g. hazard statements and precautionary statements must be in IFU, on SDS • If space allows then the hazard text should be added

The Organisation for Professionals in Regulatory Affairs

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