Recital 4

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

(4) On 1 December 2021, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (‘the requested exemption’).

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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.