Article 1
Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
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
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
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
Article 2
1.Β Β Β Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the last day of the ninth month after entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2.Β Β Β Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Article 4
This Directive is addressed to the Member States.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX In Annex IV to Directive 2011/65/EU, the following point 41 is added: β41. Lead as a thermal stabiliser 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 blood and other body fluids and body gases. Expires on 31 December 2018.β
Implementing measures in the Member States
Transposition links come from the Member Statesβ notifications published on EUR-Lex. Only high-confidence matches held on LawPlayer are listed; see EUR-Lex for the complete list.
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.
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