Recital 11

Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Text with EEA relevance) · European Union

(11) In light of the expected availability of substitution of lead in the application subject to the exemption and of possible future restrictions on lead in polyvinyl chloride in Regulation (EC) No 1907/2006, it is necessary to grant the exemption for a limited validity period until 31 December 2023. That validity period is set in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-17 · Text as adopted (Official Journal); later amendments are not incorporated in this text.