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New RoHS exemption added for in-vitro medical devices

24th Jul 2023

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The European Commission has published Delegated Directive (EU) 2023/1526 amending the RoHS Directive.

Exemption 41a exempts lead as a thermal stabilizer 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 creatinine and blood urea nitrogen in whole blood.

The exemption expires on 31 December 2023.

The limited availability of the exemption reflects the following expectations:

  1. a substitute for lead for use as a thermal stabilizer in PVC will become available
  2. lead will be further restricted under the REACH Regulation.

Companies are advised to have a plan in place to minimise the use of lead due to health concerns.

EUR-Lex – 32023L1526 – EN – EUR-Lex (


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