The European Commission has adopted Commission Delegated Directive (EU) 2023/1526, which amends Directive 2011/65/EU of the European Parliament and European Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in sensors for in vitro diagnostic medical devices (IVDs).
Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) controls the use of hazardous substances in electrical and electronic equipment in the European Union. The hazardous substances falling in scope are listed in Annex II of the directive.
As a consequence of RoHS, EU Member States must ensure that electrical and electronic equipment placed on the market do not contain the substances listed in Annex II – including lead. There are, however, a number of exemptions from this prohibition provided in Annex IV to RoHS. Examples of exemptions provided in Annex IV include lead in solders in portable emergency defibrillators, lead in X-ray test objects and cadmium in X-ray measurement filters.
The new directive amplifies the exemption related to lead that is included in Annex IV to include lead as a thermal stabilizer in PVC sensors for IVDs used for the analysis of creatinine and blood urea nitrogen.
The preamble to the directive explains that the amendment is to take account of the fact that available lead substitutes for related devices are not reliable for creatinine and blood urea nitrogen measurements. Consequently, substitution of lead for IVD sensors is not yet guaranteed. Furthermore, restriction on the use of lead sensors would negatively affect the health service. The European Commission has, therefore, provided a related exemption that will expire on 31 December 2023.