EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
ANNEX  
 
ANNEX  
to  
Commission Delegated Directive  
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   EN 1  EN ANNEX  
In Annex IV to Directive 2011/65/EU , entry  41 is replaced by the following : 
"41. 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 [the last day of the  24th month after the publication of the Delegated 
Directive in the Official Journal ]." 
 