Recital 7

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

(7) The evaluation of the requested exemption concluded that the substitution of lead in specific sensors is not completed yet. The availability of substitutes for such specific devices is not ensured as current lead substitutions are not reliable for all parameters (for example, creatinine and blood urea nitrogen) or have a low accuracy for such parameters. In addition, the evaluation concluded that rejecting the requested exemption would negatively affect the health service.

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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.