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 equipment, and in particular Article 5(1)(a) thereof,
Whereas:
(1)
Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.
(2)
SDE (stacked die elements) detector technology is used in X-ray detectors of computed tomography (CT) and X-ray systems. It offers advantages for patients as it reduces the necessary X-ray dose exposure. Large area SDE detectors cannot yet be produced with lead-free solders. The substitution and the elimination of lead are therefore scientifically and technically impracticable for the above-mentioned applications.
(3)
The use of lead in large area stacked die elements with more than 500 interconnects per interface used in X-ray detectors of CT and X-ray systems should therefore be exempted from the prohibition until 31 December 2019. In view of the innovation cycles of the medical devices and monitoring and control instruments sectors this is a relatively short transition period which is unlikely to have adverse impacts on innovation.
(4)
In accordance with the repair-as-produced principle of Directive 2011/65/EU, which is meant to extend the lifetime of compliant products once placed on the market, spare parts shall benefit from this exemption past its end date without time limitations.
(5)
Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE: