(1)

Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications which are specific to medical devices and monitoring and control instruments and are listed in Annex IV to that Directive.

(2)

The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.

(3)

Mercury is a restricted substance listed in Annex II to Directive 2011/65/EU.

(4)

By Delegated Directive (EU) 2015/574 (2), the Commission granted an exemption for the use of mercury in intravascular ultrasound imaging systems (‘the exemption’), by including that application in Annex IV to Directive 2011/65/EU. The exemption was to expire on 30 June 2019, in accordance with the third subparagraph of Article 5(2) of that Directive.

(5)

The Commission received an application for renewal of the exemption (‘the renewal request’) on 6 October 2017 that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted.

(6)

The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during these consultations were made publicly available on a dedicated website.

(7)

Mercury is used in electric rotating connectors of intravascular ultrasound imaging systems which provide the electrical conduction path between the rotating transducer and stationary electronic equipment. The use of mercury enables, inter alia, higher frequency operation which allows obtaining higher resolution imaging beneficial for patients.

(8)

Due to the lack of alternatives, a substitution or elimination of mercury in the applications concerned is currently scientifically and technically impracticable. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) and thus does not weaken the environmental and health protection afforded by it.

(9)

It is, therefore, appropriate to grant the renewal of the exemption.

(10)

The exemption should be renewed for the maximum duration of 7 years until 30 June 2026, in accordance with Article 4(3) and the third subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

(11)

Directive 2011/65/EU should therefore be amended accordingly,