Legal act: 
Commission Delegated Regulation (EU) 2019/945

Commission Delegated Regulation (EU) 2020/1058

Consolidated act:
09/08/2020 of Commission Delegated Regulation (EU) 2019/945

Commission Delegated Regulation (EU) 2019/945

Subject matter

1. This Regulation lays down the requirements for the design and manufacture of unmanned aircraft systems (‘UAS’) intended to be operated under the rules and conditions defined in Implementing Regulation (EU) 2019/947 and of remote identification add-ons. It also defines the type of UAS whose design, production and maintenance shall be subject to certification.
2. It also establishes rules on making UAS intended for use in the ‘open’ category and remote identification add-ons available on the market and on their free movement in the Union.
3. This Regulation also lays down rules for third-country UAS operators, when they conduct a UAS operation pursuant to Implementing Regulation (EU) 2019/947 within the single European sky airspace.

 

Scope

1. Chapter II of this Regulation applies to the following products:
   1. UAS intended to be operated under the rules and conditions applicable to the ‘open’ category of UAS operations pursuant to Implementing Regulation (EU) 2019/947, except privately built UAS, and bearing a class identification label as set out in Parts 1 to 5 of the Annex to this Regulation indicating to which of the five UAS classes referred to in Implementing Regulation (EU) 2019/947 it belongs to;
   2. remote identification add-ons as set out in Part 6 of the Annex to this Regulation.
2. Chapter III of this Regulation applies to UAS operated under the rules and conditions applicable to the ‘certified’ and ‘specific’ categories of UAS operations pursuant to Implementing Regulation (EU) 2019/947.
3. Chapter IV of this Regulation applies to UAS operators that have their principal place of business, are established, or reside in a third country, if the UAS are operated in the Union.
4. This Regulation does not apply to UAS intended to be exclusively operated indoors.

 

Definitions

Union harmonisation legislation means any Union legislation harmonising the conditions for placing products on the market.

CE marking means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

Manufacturer means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark.

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

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

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

Placing on the market means the first making available of a product on the Union market.

Privately built UAS means a UAS assembled or manufactured for the builder's own use, not including UAS assembled from a set of parts placed on the market by the manufacturer as a single ready-to-assemble kit.

Market surveillance authority means an authority of a Member State responsible for carrying out market surveillance on its territory.

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

 

CHAPTER II - UAS intended to be operated in the ‘open’ category and remote identification add-ons

SECTION 1 - Product requirements

Article 5 - Making available on the market and free movement of products

1. Products shall only be made available on the market if they satisfy the requirements of this Chapter and do not endanger the health or safety of persons, animals or property.
2. Member States shall not prohibit, restrict or impede, for the aspects covered by this Chapter, the making available on the market of products that comply with this Chapter.

 

SECTION 2 - Obligations of economic operators

Article 6 Obligations of manufacturers

1. When placing their product on the Union market, manufacturers shall ensure that it has been designed and manufactured in compliance with the requirements set out in Parts 1 to 6 of the Annex.
2. Manufacturers shall draw up the technical documentation provided for in Article 17 and carry out the relevant conformity assessment procedure referred to in Article 13 or have it outsourced. Where compliance of the product with the requirements set out in Parts 1 to 6 of the Annex has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the product has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Chapter. Changes in product design, characteristics or software, and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls and shall keep distributors informed of any such monitoring.
5. Manufacturers of UAS shall ensure that the UA bears a type within the meaning of Decision 768/2008/EC and a unique serial number allowing for its identification, and if applicable, compliant with the requirements defined in the corresponding Parts 2 to 4 of the Annex. Manufacturers of remote identification add-ons shall ensure that the remote identification add-on bears a type and a unique serial number allowing for their identification and compliant with the requirements defined in Part 6 of the Annex. In both cases, manufacturers shall ensure that a unique serial number is also affixed to the EU declaration of conformity or to the simplified EU declaration of conformity referred to in Article 14.
6. Manufacturers shall indicate on the product their name, registered trade name or registered trademark, website address and the postal address at which they can be contacted or, where that is not possible, on its packaging, or in a document accompanying it. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be indicated in a language easily understood by end-users and market surveillance authorities.
7. Manufacturers shall ensure that the product is accompanied by the manual and information notice required by Parts 1 to 6 of the Annex in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such manual and information notice, as well as any labelling, shall be clear, understandable and legible.
8. Manufacturers shall ensure that each product is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity. Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained.
9. Manufacturers who consider or have reason to believe that products which they have placed on the market are not in conformity with this Chapter shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Where the product presents a risk, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance, of any corrective measures taken and of the results thereof.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product with this Chapter, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product which they have placed on the market.

 

SECTION 3 Conformity of the product

Article 14 - EU declaration of conformity

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 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

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

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 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.

 

SECTION 5 - Union market surveillance, control of products entering the Union market and Union safeguard procedure

Article 35 - Market surveillance and control of products entering the Union market

1. Member States shall organise and perform surveillance of the products that are placed on the Union market in accordance with paragraph 3 of Article 15 and Articles 16 to 26 of Regulation (EC) No 765/2008.
2. Member States shall organise and perform control of the products that enter the Union market in accordance with paragraph 5 of Article 15 and Articles 27, 28 and 29 of Regulation (EC) No 765/2008.
3. Member States shall ensure that their market surveillance and border control authorities cooperate with the competent authorities designated under Article 17 of Implementing Regulation (EU) 2019/947 on safety matters and shall establish appropriate communication and coordination mechanisms between them, making the best use of the information contained in the occurrence reporting system defined in Regulation (EU) No 376/2014 of the European Parliament and of the Council (14) and the information systems defined in Articles 22 and 23 of Regulation (EC) No 765/2008.