rec_8

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

(8) While lead-free technologies are available on the market for certain analysers of other manufacturers, reliability testing of substitutes for the specific application subject to the current renewal request requires additional time.

← rec_7 · All articles · rec_9 →

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