EU: A new RoHS exemption for Lead in PVC used in in-vitro Diagnostic Medical Devices is added to Annex IV
AUGUST 2023 - ELECTRICAL AND ELECTRONICS
On 24 July 2023, the European Commission published a RoHS amendment1 to include a new exemption under Annex IV. An EU RoHS exemption application for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as the base material in sensors used in in vitro diagnostic medical devices has been granted with a validity period. The Commission concluded that the substitution of lead in specific sensors is not completed yet. Hence, the exemption is granted for a limited period of time. Details of the exemption are listed in Table A.
The amendment shall enter into force on 13 Aug 2023. The EC also published a corrigendum2 to mention the dates when Member States shall adopt and apply this Directive.
Table A. Newly added entry 41a in Annex IV
| Exemption No. | Exemption application | Category and expiry date |
| 41a | 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 | Applies to category 8 and expires on 31 December 2023 |
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