ANNEX

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

In Annex IV to Directive 2011/65/EU, the following entry 41a is added: Lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in vitro diagnostic medical devices for the analysis of creatinine and blood urea nitrogen in whole blood. Applies to category 8 and expires on 31 December 2023.’.

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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.