Commission Delegated Regulation (EU) 2019/945 of 12 March 2019 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems

CHAPTER I

General provisions

Article 1

Subject matter

Article 2

Scope

Chapter II of this Regulation applies to the following products:

(a) UAS intended to be operated under the rules and conditions applicable to the ‘open’ category of UAS operations or to operational declarations under the ‘specific’ category of UAS operations pursuant to Regulation (EU) 2019/947, except privately built UAS, and bearing a class identification label as set out in Parts 1 to 5, 16 and 17 of the Annex to this Regulation indicating to which of the seven UAS classes referred to in Implementing Regulation (EU) 2019/947 it belongs;

(b) class C5 accessories kits as set out in Part 16;

(c) remote identification add-ons as set out in Part 6 of the Annex to this Regulation.

Article 3

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘unmanned aircraft’ (‘UA’) means any aircraft operating or designed to operate autonomously or to be piloted remotely without a pilot on board;

(2) ‘equipment to control unmanned aircraft remotely’ means any instrument, equipment, mechanism, apparatus, appurtenance, software or accessory that is necessary for the safe operation of a UA other than a part and which is not carried on board that UA;

(3) ‘unmanned aircraft system’ (‘UAS’) means an unmanned aircraft, as defined in Article 3 point (30) of Regulation (EU) 2018/1139 (¹), and its control and monitoring unit;

(4) ‘unmanned aircraft system operator’ (‘UAS operator’) means any legal or natural person operating or intending to operate one or more UAS;

(5) ‘open’ category' means a category of UAS operations that is defined in Article 4 of Implementing Regulation (EU) 2019/947;

(6) ‘specific’ category means a category of UAS operations that is defined in Article 5 of Implementing Regulation (EU) 2019/947;

(7) ‘certified’ category means a category of UAS operation that is defined in Article 6 of Implementing Regulation (EU) 2019/947;

(8) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for placing products on the market;

(9) ‘accreditation’ means accreditation as defined in paragraph 10 of Article 2 of Regulation (EC) No 765/2008;

(10) ‘conformity assessment’ means the process demonstrating whether the specified requirements relating to a product have been fulfilled;

(11) ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(12) ‘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;

(13) ‘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;

(14) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(15) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(16) ‘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;

(17) ‘economic operators’ means the manufacturer, the authorised representative of the manufacturer, the importer, and the distributor of the UAS;

(18) ‘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;

(19) ‘placing on the market’ means the first making available of a product on the Union market;

(20) ‘harmonised standard’ means a harmonised standard as defined in point (c) of Article 2(1) of Regulation (EU) No 1025/2012;

(21) ‘technical specification’ means a document that establishes technical requirements to be fulfilled by a product, process or service;

(22) ‘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;

(23) ‘market surveillance authority’ means an authority of a Member State responsible for carrying out market surveillance on its territory;

(24) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end-user;

(25) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;

(26) ‘single European sky airspace’ means airspace above the territory to which the Treaties apply, as well as any other airspace where Member States apply Regulation (EC) No 551/2004 of the European Parliament and of the Council (²) in accordance with paragraph 3 of Article 1 of that Regulation;

(27) ‘remote pilot’ means a natural person responsible for safely conducting the flight of a UA by operating its flight controls, either manually or, when the UA flies automatically, by monitoring its course and remaining able to intervene and change its course at any time;

(28) ‘maximum take-off mass’ (‘MTOM’) means the maximum UA mass, including payload and fuel, as defined by the manufacturer or the builder, at which the UA can be operated;

(29) ‘payload’ means any instrument, mechanism, equipment, part, apparatus, appurtenance, or accessory, including communications equipment, that is installed in or attached to the aircraft, and is not used or intended to be used in operating or controlling an aircraft in flight, and is not part of an airframe, engine, or propeller;

(30) ‘follow-me mode’ means a mode of operation of a UAS where the unmanned aircraft constantly follows the remote pilot within a predetermined radius;

(31) ‘direct remote identification’ means a system that ensures the local broadcast of information about a UA in operation, including the marking of the UA, so that this information can be obtained without physical access to the UA;

(32) ‘geo-awareness’ means a function that, based on the data provided by Member States, detects a potential breach of airspace limitations and alerts the remote pilots so that they can take effective immediate and action to prevent that breach;

(33) ‘sound power level LWA’ means the A-weighted sound power in dB in relation to 1 pW as defined in EN ISO 3744:2010;

(34) ‘measured sound power level’ means a sound power level as determined from measurements as laid down in Part 13 of the Annex; measured values may be determined either from a single UA representative for the type of equipment or from the average of a number of UA;

(35) ‘guaranteed sound power level’ means a sound power level determined in accordance with the requirements laid down in Part 13 of the Annex which includes the uncertainties due to production variation and measurement procedures and where the manufacturer, or his authorised representative established in the Community, confirms that according to the technical instruments applied and referred to in the technical documentation it is not exceeded;

(36) ‘hovering’ means staying in the same geographical position in the air;

(37) ‘assemblies of people’ means gatherings where persons are unable to move away due to the density of the people present;

(38) ‘control and monitoring unit’ (‘CMU’) means the equipment to control and monitor unmanned aircraft remotely, as defined in Article 3 point (32) of Regulation (EU) 2018/1139;

(39) ‘C2 link’ means the data link between the unmanned aircraft and the CMU for the purposes of managing the flight;

(40) ‘night’ means the hours between the end of evening civil twilight and the beginning of morning civil twilight as defined in Implementing Regulation (EU) No 923/2012. (³)

CHAPTER II

UAS intended to be operated in the ‘open’ category or in the ‘specific’ category under operational declaration, accessories kits bearing a class identification label and remote identification add-ons

SECTION 1

Product requirements

Article 4

Requirements

Article 5

Making available on the market and free movement of products

SECTION 2

Obligations of economic operators

Article 6

Obligations of manufacturers

Where compliance of the product with the requirements set out in Parts 1 to 6, 16 and 17 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.

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.

Article 7

Authorised representatives

The obligations laid down in paragraph 1 of Article 6 and the obligation to draw up the technical documentation referred to in paragraph 2 of Article 6 shall not form part of the authorised representative's mandate.

An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the product has been placed on the Union market;

(b) further to a reasoned request from a market surveillance or border control authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the product;

(c) cooperate with the market surveillance or border control authorities, at their request, on any action taken to eliminate the non-conformity of the products covered by the authorised representative's mandate or the safety risks posed by it.

Article 8

Obligations of importers

Before placing a product on the Union market, importers shall ensure that:

(a) the appropriate conformity assessment procedure referred to in Article 13 has been carried out by the manufacturer;

(b) the manufacturer has drawn up the technical documentation referred to in Article 17;

(c) the product bears the CE marking and, when required, the UA class identification label and the indication of the sound power level;

(d) the product is accompanied by the documents referred to in paragraph 7 and 8 of Article 6;

(e) the manufacturer has complied with the requirements set out in paragraphs 5 and 6 of Article 6.

Where an importer considers or has reasons to believe that a product is not in conformity with the requirements set out in Parts 1 to 6, 16 and 17 of the Annex, they shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a risk for the health and safety of consumers and third parties, the importer shall inform the manufacturer and the competent national authorities to that effect.

Article 9

Obligations of distributors

Distributors shall ensure that the product is accompanied by the manufacturers’ instructions and information notice required by Parts 1 to 6, 16 and 17 of the Annex in a language which can be easily understood by consumers and other end users, as determined by the Member State concerned. Those manufacturers’ instructions and information notice, as well as any labelling, shall be clear, understandable and legible.

Where a distributor considers or has reason to believe that a product is not in conformity with the requirements set out in Article 4, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer or the importer to that effect, as well as the competent market surveillance authorities.

Article 10

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Chapter and shall be subject to the obligations of manufacturers pursuant to Article 6, where they place a product on the market under their name or trademark or modify the product already placed on the market in such a way that compliance with this Chapter may be affected.

Article 11

Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

(a) any economic operator who has supplied them with a product;

(b) any economic operator to whom they have supplied a product.

Economic operators shall be able to present the information referred to in paragraph 1:

(a) for 10 years after they have been supplied with the product;

(b) for 10 years after they have supplied the product.

SECTION 3

Conformity of the product

Article 12

Presumption of conformity

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

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

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

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.

Article 17

Technical documentation

SECTION 4

Notification of conformity assessment bodies

Article 18

Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Chapter.

Article 19

Notifying authorities

Article 20

Requirements relating to notifying authorities

A notifying authority shall:

(a) be established in such a way that no conflict of interest with conformity assessment bodies occurs;

(b) be organised and operated so as to safeguard the objectivity and impartiality of its activities;

(c) be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment;

(d) not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis;

(e) shall safeguard the confidentiality of the information it obtains;

(f) have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Article 21

Information obligation on notifying authorities

Article 22

Requirements relating to notified bodies

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of the product which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that product, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall, in particular, apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

At all times and for each conformity assessment procedure and each kind or category of product in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures; it shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;