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Commission Delegated Directive (EU) 2020/366 of 17 December 2019 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (Text with EEA relevance) · European Union

(7) Lead in the PVC sensor card of concerned in vitro medical devices (blood analysers) enhances sensor performance which is necessary for the optimum performance of the device in terms of analytical reliability claimed in product publications and thus for fulfilment of requirements laid down in Directive 98/79/EC of the European Parliament and of the Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). .

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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.