rec_9

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

(9) Discontinuation of the exemption is expected to avoid a total of 157 kg of lead being placed on the Union market. At the same time, however, it will result in the need to replace the entire diagnostic device, and consequently, is expected to lead to a premature generation of 112000 kg of waste electrical and electronic equipment. Furthermore, significant socioeconomic impacts on health providers using the devices concerned would be incurred.

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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.