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Commission Delegated Directive (EU) 2015/573 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices Text with EEA relevance · European Union

(4) The use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-vitro diagnostic medical devices should therefore be exempted until 31 December 2018. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-18 · Text as adopted (Official Journal); later amendments are not incorporated in this text.