# Commission Delegated Directive 2014/13/EUShow full title

Commission Delegated Directive 2014/13/EU of 18 October 2013 amending, for the purposes of adapting to technical progress,            the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders            on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable            emergency defibrillators (Text with EEA relevance)         

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U.K.

# Commission Delegated Directive 2014/13/EU                     

# of 18 October 2013

# amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament                        and of the Council as regards an exemption for lead in solders on populated printed circuit boards used in Directive 93/42/EEC                        class IIa and IIb mobile medical devices other than portable emergency defibrillators                     

# (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(1), 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)Mobile medical devices are medical devices which are designed and approved by a notified body according to Council Directive                              93/42/EEC(2) to be hand carried, or to be transported on own wheels, on a cart or trolley or in a vehicle, aircraft or vessel during and/or                              between operations.

(3)Substitution or elimination of lead in the populated printed circuit boards of mobile medical devices is currently technically                              impracticable. A temporary exemption to allow the continued use of lead solders is needed until further research has been                              carried out to identify alloys that are reliable for the normal life of mobile medical devices.

(4)Directive 2011/65/EU should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

# Article 1U.K.

Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

# Article 2U.K.

1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive                        by the last day of the sixth month after entry into force at the latest. They shall forthwith communicate to the Commission                        the text of those provisions.                  

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference                     on the occasion of their official publication. Member States shall determine how such reference is to be made.                  

2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the                        field covered by this Directive.                  

# Article 3U.K.

This Directive shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

# Article 4U.K.

This Directive is addressed to the Member States.

Done at Brussels, 18 October 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

In Annex IV to Directive 2011/65/EU the following point 33 is added:

Lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other                                 than portable emergency defibrillators. Expires on 30 June 2016 for class IIa and on 31 December 2020 for class IIb.’                           

1

OJ L 174, 1.7.2011, p. 88.                           

2

OJ L 169, 12.7.1993, p. 1.