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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment1, and in particular Article 5(1)(a) thereof,
Whereas:
Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.
Blood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures. Lead is required as a stabiliser in the processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative is not yet available. The performance of tested alternatives both to lead in PVC and to PVC itself does not meet the specific technical requirements.
Both the substitution of lead in PVC sensor cards for in-vitro diagnostic medical devices for blood, body fluid and body gas analysis and the elimination of lead via substitution of PVC in these applications are technically impracticable.
The use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-vitro diagnostic medical devices should therefore be exempted until 31 December 2018. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.
Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE: