Article 12 - Presumption of conformity

Regulation (EU) 2020/1058

A product which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in Parts 1 to 6, 16 and 17 of the Annex.

Article 13 - Conformity assessment procedures

Regulation (EU) 2020/1058

1. The manufacturer shall perform a conformity assessment of the product using one of the following procedures with a view to establishing its compliance with the requirements set out in Parts 1 to 6, 16 and 17 of the Annex. The conformity assessment shall take into account all intended and foreseeable operating conditions.

2. The procedures available to conduct the conformity assessment shall be the following:

(a) internal production control as set out in Part 7 of the Annex, when assessing the compliance of a product with the requirements set out in Parts 1, 5, 6, 16 or 17 of the Annex, subject to the condition that the manufacturer has applied harmonised standards, the references of which have been published in the Official Journal of the European Union, for all the requirements for which such standards exist;

(b) EU-type examination followed by conformity to type based on internal production control as set out in Part 8 of the Annex;

(c) conformity based on full quality assurance as set out in Part 9 of the Annex, excepted when assessing the compliance of a product which is a toy within the meaning of Directive 2009/48/EC.

Article 14 - EU declaration of conformity

Regulation (EU) 2020/1058

1. The EU declaration of conformity referred to in paragraph 8 of Article 6 shall state that compliance of the product with the requirements set out in Parts 1 to 6, 16 and 17 of the Annex has been demonstrated and, for UAS, identify its class.

2. The EU declaration of conformity shall have the model structure set out in Part 11 of the Annex, shall contain the elements set out in that Part and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which market the product is placed or made available.

3. The simplified EU declaration of conformity referred to in paragraph 8 of Article 6 shall contain the elements set out in Part 12 of the Annex and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market. The full text of the EU declaration of conformity shall be available at the internet address referred to in the simplified EU declaration of conformity in a language or languages required by the Member State in which the product is placed or made available on the market.

4. Where a product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references.

5. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements laid down in this Chapter.

Article 15 - General principles of the CE marking

Regulation (EU) 2019/945

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

Article 16 - Rules and conditions for affixing the CE marking, the identification number of the notified body, the UAS class identification label and the indication of the sound power level

Regulation (EU) 2020/1058

1. The CE marking shall be affixed visibly, legibly and indelibly to the product or to the data plate attached to it. Where that is not possible or not warranted on account of the size of the product, it shall be affixed to the packaging.

2. The UA class identification label shall be affixed visibly, legibly and indelibly to the UA or, when relevant, to each accessories of a class C5 accessories kit, and its packaging and shall be at least 5 mm high. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the class identification label shall be prohibited.

3. The indication of the sound power level provided for in Part 14 of the Annex shall be affixed, when applicable, visibly, legibly and indelibly on the UA, unless that is not possible or not warranted on account of the size of the product, and on the packaging.

4. The CE marking and, when applicable, the indication of the sound power level and the UA class identification label shall be affixed before the product is placed on the market.

5. The CE marking shall be followed by the identification number of the notified body where the conformity assessment procedure set out in Part 9 of the Annex is applied.

The identification number of the notified body shall be affixed by the notified body itself or, under its instructions, by the manufacturer or his authorised representative.

6. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Article 17 - Technical documentation

Regulation (EU) 2020/1058

1. The technical documentation shall contain all relevant data and details of the means used by the manufacturer to ensure that the product complies with the requirements set out in Parts 1 to 6, 16 and 17 of the Annex. It shall, at least, contain the elements set out in Part 10 of the Annex.

2. The technical documentation shall be drawn up before the product is placed on the market and shall be continuously updated.

3. The technical documentation and correspondence relating to any EU-type examination procedure or the assessment of the quality system of the manufacturer shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body.

4. Where the technical documentation does not comply with paragraphs 1, 2 or 3 of this Article, the market surveillance authority may ask the manufacturer or the importer to have a test performed by a body acceptable to the market surveillance authority at the expense of the manufacturer or the importer within a specified period in order to verify compliance of the product with the requirements set out in Parts 1 to 6, 16 and 17 of the Annex which applies to it.