Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

REACH – 1907/2006 Registration, Evaluation, Restriction and Authorisation of Chemicals

Managed by ECHA

• Registration of chemicals >1 tonne

• Manage substances of very high concern (SVHC)

• Last update of SVHC candidate list 10 June 2022, 224 substances currently on list REACH SVHC Finder

• SVHC Authorization list has 43 substances •

Tritons (X-100 listed June 2017, sunset 04 Jan 2021

The Organisation for Professionals in Regulatory Affairs

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REACH – 1907/2006 Registration, Evaluation, Restriction and Authorisation of Chemicals

 Impact for IVDs

• Referenced in Annex I, Chapter II, 10.3 Article 59 of Regulation (EC) No 1907/2006 • Provision of REACH shall apply to the safety data sheet (SDS) unless all relevant information is made available in Instructions for Use (IFU)

• SDS must be translated into EU national languages

And Finally……. • A scientific exemption is in place for Triton present in finished IVD • Is used in quantities <1 tonne per year • Keep an eye on Annex XIV, other chemicals are under review

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