Legal act: 
Directive 2011/65/EU
Directive (EU) 2017/2102

Consolidated act:
1/09/2023 of Directive 2011/65/EU

Scope

This Directive shall apply to EEE (Electrical and Electronic Equipment) falling within the categories set out in Annex I:

1. Large household appliances.
2. Small household appliances.
3. IT and telecommunications equipment.
4. Consumer equipment.
5. Lighting equipment.
6. Electrical and electronic tools.
7. Toys, leisure and sports equipment.
8. Medical devices.
9. Monitoring and control instruments including industrial monitoring and control instruments.
10. Automatic dispensers.
11. Other EEE not covered by any of the categories above.

 This Directive does not apply to:

1. equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war material intended for specifically military purposes;
2. equipment designed to be sent into space;
3. equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment;
4. large-scale stationary industrial tools;
5. large-scale fixed installations;
6. means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved;
7. non-road mobile machinery made available exclusively for professional use;
8. active implantable medical devices;
9. photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications;
10. equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.

Definitions

Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EEE available on the market.

Importer means any natural or legal person established within the Union, who places an EEE from a third country on the Union market.

Making available on the market’ means any supply of an EEE for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

Placing on the market means making available an EEE on the Union market for the first time.

Market surveillance means the activities carried out and measures taken by public authorities to ensure that EEE complies with the requirements set out in this Directive and does not endanger health, safety or other issues of public interest protection.

Withdrawal means any measure aimed at preventing a product in the supply chain from being made available on the market.

Article 13 - EU declaration of conformity

1. The EU declaration of conformity shall state that it has been demonstrated that the requirements specified in Article 4 have been met.
2. The EU declaration of conformity shall have the model structure and shall contain the elements specified in Annex VI and shall be updated. It shall be translated into the language or languages required by the Member State on the market of which the product is placed or made available. Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of this Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE with this Directive.

Article 14 - General principles of the CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 15 - Rules and conditions for affixing the CE marking

1. The CE marking shall be affixed visibly, legibly and indelibly to the finished EEE or to its data plate. Where that is not possible or not warranted on account of the nature of the EEE, it shall be affixed to the packaging and to the accompanying documents.
2. The CE marking shall be affixed before the EEE is placed on the market.
3. Member States shall build upon existing mechanisms to ensure the correct application of the regime governing the CE marking and take appropriate action in the event of improper use of the CE marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.