Article 1
Annex IV to Directive 2011/65/EU is amended as set out...
Article 2
(1) Member States shall bring into force the laws, regulations...
Article 3
This Directive shall enter into force on the twentieth day...
Article 4
This Directive is addressed to the Member States.
ANNEX
In Annex IV to Directive 2011/65/EU, the following point 42...
42. Mercury in electric rotating connectors used in intravascular ultrasound...
Commission Delegated Directive (EU) 2015/574
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 mercury in intravascular ultrasound imaging systems
(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 equipment , and in particular Article 5(1)(a) thereof,
Whereas:
(1)
Directive 2011/65/EU prohibits the use of mercury in electrical and electronic equipment placed on the market.
(2)
Mercury is used in electric rotating connectors in medical devices for intravascular ultrasound imaging. Substitution of mercury or of the specific component would shorten product life or impair performance significantly.
(3)
Both the substitution of mercury in the connector and the elimination of mercury via substitution of the connector or the device are technically impracticable or have negative overall impacts due to an impact on patients' health.
(4)
The use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency modes of operation (> 50 MHz) should therefore be exempted until 30 June 2019. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.
(5)
Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE:
OJ L 174, 1.7.2011, p. 88.