EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
on unmanned aircraft intended for use in the ‘open’ category, and on third -country 
operators of unmanned aircraft systems  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.   
Ref. Ares(2018)5119839 - 05/10/2018 
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
With the adoption of the EASA new basic Regulation, the EU will be competent for all 
unmanned aircraft, irrespective of their weight. Consequently, it is necessary to set out the 
requirements that address the risks posed by the operation of such unmanned a ircraft , taking 
full account of other applicable Union harmonisation legislation, as well as the type of aircraft 
and category of  operations  concerned. The main objective of this initiative is to establish 
detailed rules for unmanned aircraft where it conc erns their design, engines, propellers, parts, 
non-installed equipment and equipment to control the aircraft remotely. It concerns in 
particular the provision on the marketing of unmanned aircraft  intended to be operated in the 
‘open’ category , which prese nt a low risk for the safety of people on the ground and in the air.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
In accordance with Article 128(4) of Regulation (EU)  2018/1139 , before adopting a delegated 
act, the Commission shall consult experts designated by each Member State in accordance 
with principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law -
Making. It is foreseen to present the draft of t he delegated act at the meeting of the 
Commission drone expert s group  including representatives from the Member States at its 
meeting in October 2018. EASA  produced its final opinion  on 6 February 2018 which 
followed its Notice of Proposed Amendment for a new regulation on drones and which has 
been supported by an impact assessment and stakeholder consultations . 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The Commission is empowered to adopt delegated acts, in accordance with Article 128, 
laying down detailed ru les with regard to the necessary features and functionalities related  to 
unmanned aircraft .  
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
on unmanned aircraft intended for use in the ‘open’ category  , and on third -country 
operators of unmanned aircraft systems  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) 1139/2018 of the European Parliament and of the Council 
of 4 July 2018 on common rules in the field of civil aviation and establishing a European 
Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 
1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 
2014/53/E U of the European Parliament and of the Council, and repealing Regulations (EC) 
No 552/2004   and (EC) No 216/2008 of the European Parliament  and of the Council and 
Council Regulation (EEC) No 3922/911, and in particular Article 58 thereof,  
Whereas:  
(1) The unm anned aircraft systems (UAS) whose  operation present s the lowest risks  and 
that belong to the 'open' category of operations  should not be subject to classic 
aeronautical compliance procedures. The possibility to establish Community  
harmonisation legislatio n referred to in Article 56(6)  of Regulation (EU) 2018/1139  
should be used for such UAS . Consequently, it is necessary to  set out the requirements 
that address the risks posed by the operation of such UAS, taking full account of other 
applicable Union harmonisation legislation.  
(2) These requirements sh ould cover the essential requirements provide d for in  Article 55 
of Regulation (EU) 2018/1139 , in particular  as regards  the specific features and 
functionalities necessary to mitigate risks pertaining to safe ty, privacy, protection of 
personal data, security or the environment, arising from the operation  these UAS.   
(3) When manufacturer s place  a UAS on the market  with the intention to make it available 
for operation s under the ‘open ’ category  and therefor e affix  a class  identification label 
on it, they should  ensure compliance of the UAS with the requirements  of that class . 
(4) This Regulation should also apply to UAS which are  considered as  toys within the 
meaning of Directive 2009/48/EC  of the European Parliament and of the Council2. 
Such  UAS sh ould also  comply with Directive 2009/48/EC. This compliance should be 
taken into account when defining additional safety requirements under this Regulation.  
(5) UAS that are not toys in the meaning of  Directive 2009/48/EC sh ould comply with the 
relevant essential health and s afety requirements set out in Directive 2006/42/EC  of 
                                                 
(1)  OJ L 212, 22.8.2018, p.1.  
(2)  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of 
toys (OJ L 170, 30.6.2009, p. 1).   
EN 3  EN the European Parliament and of the Council3 where identified hazards are not covered 
more specifically by requirements defined  in this Regulation.  
(6) Unmanned aircraft and their engines, propellers, parts and non -installed equipment 
falling within the scope of Regulation (EU) 2018/1139  and intended exclusively for 
airborne use are excluded from the scope of Directive 2014/30/EU4 and Directive 
2014/53/EU5 of the European Parliament and of the Council  only from the moment 
and in as far as the design of the unmanned aircraft and of their engines, propellers, 
parts and non -installed equipment are certified in accordance with Regulation (EU) 
2018/1139  and intended to be operated only on frequencies allocat ed by the Radio 
Regulations of the International Telecommunication Union for protected aeronautical 
use. Consequently, Directive 2014/53/EU and, for unmanned aircraft and their 
engines, propellers, parts and non -installed equipment that do not communicate with 
radio waves  at frequencies below 3000 GHz , Directive 2014/30/EU, apply to 
unmanned aircraft and their engines, propellers, parts and non -installed equipment 
operating in the ‘open’ category.  
(7) Decision No 768/2008/EC of the European Parliament and of th e Council6 sets out 
common principles and horizontal provisions intended to  apply  to marketing of 
products that are subject to relevant sectorial legislation. In order to ensure consistency 
with other sectorial product legislation, the provision on the mar keting of UAS 
intended to be operated in the ‘open’ category  should be aligned with the framework 
established by Decision 768/2008/EC . 
(8) Directive 2001/95/EC7 applies to safety risks  of UAS subject to this Regulation  in so 
far as there are no specific provis ions with the same objective in rules of Union  law 
governing the safety of the products concerned . 
(9) This Regulation should apply to all forms of supply, including distance selling.  
(10) Member States should take the necessary steps to ensure that UAS are made available 
on the market and put into service only where they do not compromise the health and 
safety of persons, domestic animals or property, when normally used.  
(11) In order to  provide citizens with high level of environmental protection , it is necessary  
to limit the noise emissions to the greatest possible extent, sound power limitations 
might be reviewed at the end of the transition periods.   
(12) Special attention should be paid to ensure compliance of products in the context of an 
increase of e -commerce. To th at end, Member States should be encouraged to pursue 
cooperation with the competent authorities in third countries and to develop 
                                                 
(3) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, 
and amending Directive 95/16/EC  (OJ L 157,  9.6.2006, p. 24).  
(4) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the 
harmonisation of the laws of the Member States relating to electromagnetic compatibility  (OJ L 96, 
29.3.2014, p. 79).  
(5) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of 
radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62) . 
(6) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a 
common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 
218, 13.8.2008, p. 82).  
(7)  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general 
product safety (OJ L 11, 15.1.2002, p. 4).   
EN 4  EN cooperation between market surveillance authorities and customs  authorities . Market 
surveillance authorities should make use, when possible, of the ‘notice and action’ 
procedures and establish cooperation with their national authorities competent for the 
implementation of the Directive 2000/31/EC of the European Parliament and of the 
Council8. They should establish close contacts  allowing rapid response with key 
intermediaries that provide hosting services for products sold online.  Member States 
should take the necessary steps to ensure that UAS  are made available on the market 
and put into service only where they do not compromis e the health and safety of 
persons, domestic animals or property, when normally used.  
(13) In order to ensure a high level of protection of public interests, such as health safety, 
and to guarantee fair competition on the Union market, e conomic operators should  be 
responsible for the compliance of UAS intended to be operated in the ‘open’ category 
with the requirements laid down in this Regulation, in relation to their respective roles 
in the supply  and distribution  chain. Th erefore, it is necessary to provide a  clear and 
proportionate distribution of obligations , which correspond to the role of each 
economic operator in the supply and distribution chain.  
(14) In order to facilitate communication between economic operators, national market 
surveillance authorities and  consumers, Member States should encourage economic 
operators to provide a website address in addition to the postal address.  
(15) The manufacturer, having detailed knowledge of the design and production process, is 
best placed to carry out the conformity asses sment procedure. Conformity assessment 
should therefore remain solely the obligation of the manufacturer.  
(16) This Regulation should apply to any UAS that is new to the Union market, whether a 
new UAS made by a manufacturer established in the Union or a new or  second -hand 
UAS imported from a third country.  
(17) It is necessary to ensure that UAS from third countries entering the Union market 
comply with the requirements of this Regulation if they are intended to be operated in 
the ‘open’ category and, in particular,  that manufacturers have carried out appropriate 
conformity assessment procedures. Provision should therefore be made for importers 
to make sure that the UAS they place on the market comply with the requirements of 
this Regulation and that they do not plac e on the market UAS which do not comply 
with these requirements or which present a risk. Provision should also be made for 
importers to make sure that the conformity assessment procedures have been carried 
out and that the CE marking and technical document ation drawn up by the 
manufacturers is available for inspection by the competent national authorities.  
(18) The distributor who makes a UAS intended to be operated in the ‘open’ category 
available on the market should  act with due care to ensure that its handli ng of the 
product does not adversely affect its compliance. Both importers and distributors are 
expected to act with due care in relation to the requirements applicable when placing 
or making products available on the market.  
(19) When placing on the market UAS  intended to be operated in the ‘open’ category, 
every importer should indicate on the UAS his name, registered trade name or 
registered trademark and the address at which he can be contacted. Exceptions should 
                                                 
(8) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal 
aspects of information society services, in particular electronic commerce, in the Internal Market 
(‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).   
EN 5  EN be provided for in cases where the size or na ture of the UAS does not allow this. This 
includes cases where the importer would have to open the packaging to put his name 
and address on the UAS.  
(20) Any economic operator that either places a UAS intended to be operated in the ‘open’ 
category on the market  under his own name or trademark, or modifies a UAS intended 
to be operated in the ‘open’ category in such a way that compliance with the 
applicable requirements  may be affected, should be considered to be the manufacturer 
and should assume the obligation s of the manufacturer.  
(21) Distributors and importers, being close to the market place, should be involved in 
market surveillance tasks carried out by the competent national authorities, and should 
be prepared to participate actively, providing those authorit ies with all the necessary 
information relating to the UAS concerned.  
(22) Ensuring the traceability of a UAS intended to be operated in the ‘open’ category 
throughout the whole supply chain helps to make market surveillance simpler and 
more efficient. An effi cient traceability system facilitates the market surveillance 
authorities’ task of tracing economic operators who make non -compliant UAS 
available on the market.  
(23) This Regulation should be limited to the setting out  of the essential requirements. In 
order to facilitate conformity assessment with those requirements, it is necessary to 
provide for a presumption of conformity for products , which are in conformity with 
harmonised standards that are adopted in accordance with Regulation (EU) No 
1025/2012 of the Europea n Parliament and of the Council9 for the purpose of setting 
out detailed technical specifications of those requirements.  
(24) The essential requirements should be worded precisely enough to create legally 
binding obligations. They should be formulated so  as to make it possible to assess 
conformity with them even in the absence of harmonised standards or where the 
manufacturer chooses not to apply a harmonised standard.  
(25) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised 
standards where those standards do not entirely satisfy the requirements of the 
harmonisation legislation included in this Regulation.  This procedure should apply 
where appropriate in relation to standards which reference have been published in the 
Official J ournal as providing presumption of conformity with the requirements laid 
down in this Regulation.  
(26) To enable economic operators to demonstrate and the competent authorities to ensure 
that UAS intended to be operated in the ‘open’ category made available on the market 
comply with  the essential requirements, it is necessary to provide for conformity 
assessment procedures. Decision No 768/2008/EC sets out modules for conformity 
assessment procedures, which include procedures from the least to the most stringent , 
in proportion to the level of risk involved and the level of safety required. In order to 
ensure inter -sectorial coherence and to avoid ad hoc variants  of conformity 
                                                 
(9) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European standardisation, amend ing Council Directives 89/686/EEC and 93/15/EEC and Directives 
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliament and of the Council and repealing Council Decision 
87/95/EEC and De cision No  1673/2006/EC of the European Parliament and of the Council (OJ L 316, 
14.11.2012, p. 12).   
EN 6  EN assessment , conformity assessment procedures should be chosen from among those 
modules.  
(27) Market surveillance authorities and UAS operators should have easy access to the EU 
declaration of conformity. In order to fulfil this requirement, manufacturers should 
ensure that each UAS intended to be operated in the ‘open’ category is accompanied 
either by a copy of the EU declaration of conformity or by the internet address at 
which the EU declaration of conformity can be accessed.  
(28) To ensure effective access to information for market surveillance purposes, the 
information required to identify all appl icable Union acts for UAS intended to be 
operated in the ‘open’ category should be available in a single EU declaration of 
conformity. In order to reduce the administrative burden on economic operators, it 
should be possible for that single EU declaration of conformity to be a dossier made 
up of relevant individual declarations of conformity.  
(29) The CE marking indicating the conformity of a product is the visible consequence of a 
whole process of conformity assessment in the broad sense. The general principles  
governing the CE marking are set out in Regulation (EC) No 765/2008. Rules 
governing the affixing of the CE marking to UAS intended to be operated in the 
‘open’ category should be laid in this Regulation.  
(30) Some  UAS classes intended to be operated in the ‘open’ category covered by this 
Regulation require the intervention of conformity assessment bodies. Member States 
should notify the Commission of these.  
(31) It is necessary to ensure a uniformly high level of performance of  bodies performing  
conformity asses sments of UAS intended to be operated in the ‘open’ category 
throughout the Union, and that all such bodies perform their functions at the same 
level and under conditions of fair competition. Therefore, obligatory requirements 
should be set for conformity assessment bodies wishing to be notified in order to 
provide conformity assessment services.  
(32) If a conformity assessment body demonstrates conformity with the criteria laid in 
harmonised standards, it should be presumed to comply with the corresponding 
requirements set out in this Regulation.  
(33) In order to ensure a consistent level of conformity assessment quality, it is also 
necessary to set requirements for notifying authorities and other bodies involved in the 
assessment, notification and monitoring of noti fied bodies.  
(34) Regulation (EC) No 765/2008 of the European  Parliament and of the Council10 sets 
out rules on the accreditation of conformity assessment bodies, provides a framework 
for the market surveillance of products and for controls on products from third 
countries, and sets out the general principles of the CE marking. The system set out in 
this Regulation should be complemented by the accreditation system provided for in 
Regulation (EC) No 765/2008.  
(35) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confidence in certificates of conf ormity, should be considered 
                                                 
(10) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting 
out the requirements for accreditation and market surve illance relating to the marketing of products 
and repealing Regulation (EEC) No  339/93 (OJ L 218, 13.8.2008, p.  30).  
EN 7  EN by national public authorities throughout the Union as the means of demonstrating the 
technical competence of conformity assessment bodies.  
(36) Conformity assessment bodies frequently subcontract parts of their activities linked to  
the assessment of conformity or have recourse to a subsidiary. In order to safeguard 
the level of protection required for the UAS intended  to be operated in the ‘open’ 
category to be placed on the Union market, it is essential that conformity assessment 
subcontractors and subsidiaries fulfil the same requirements as notified bodies do in 
relation to the performance of conformity assessment tasks. Therefore, it is important 
that the assessment of the competence and performance of bodies to be notified, and 
the monitoring of bodi es already notified, also cover  activities carried out by 
subcontractors and subsidiaries.  
(37) It is necessary to increase the efficiency and transparency of the notification procedure 
and, in particular, to adapt it to new technologies s o as to enable online notification.  
(38) Since notified bodies may offer their services throughout the Union, it is appropriate to 
give the other Member States and the Commission the opportunity to raise objections 
concerning a notified body . It is therefore im portant to provide for a period during 
which any doubts or concerns as to the competence of conformity assessment bodies 
can be clarified, before they start operating as notified bodies.  
(39) In the interests of competitiveness, it is crucial that notified bodi es apply the 
conformity assessment procedures without creating unnecessary administrative burden 
for economic operators. For the same reason, and to ensure equal treatment of 
economic operators, consistency in the technical application of the conformity 
assessment procedures needs to be ensured. This can best be achieved through 
appropriate coordination and cooperation between notified bodies.  
(40) Interested parties should have the right to appeal against the result of a conformity 
assessment carried out by a n otified body. It is important to ensure that an appeal 
procedure against decisions taken by notified bodies is available.  
(41) Member States should take all appropriate measures to ensure that UAS covered by 
this Regulation may be placed on the market only if, when properly stored and used 
for their intended purpose or under conditions which can be reasonably foreseen, it 
does not endanger people’s health or safety. UAS covered by this Regulation should 
be considered as non -compliant with the essential requireme nts set out in this 
Regulation  only under conditions of use which can be reasonably foreseen, that is 
when such use could result from lawful and readily predictable human behaviour.  
(42) In order to ensure legal certainty, it is necessary to clarify that the ru les on Union 
market surveillance and control of products entering the Union market provided for in 
Regulation (EC) No 765/2008 , including the provisions regarding the exchange of 
information through the Rapid Alert System (RAPEX), apply to products falling  
within the scope of this Regulation. This Regulation should not prevent Member 
States from choosing the competent authorities to carry out those tasks. In order to 
ensure a smooth transition as regards the implementation of this Regulation, 
appropriate tr ansitional measures should be provided.  
(43) UAS operators that have their principal place of business, are established, or are 
resident in a third country and that conduct UAS operations within or outside of the 
single European sky airspace should be subject to this Regulation .  
EN 8  EN (44) The measures provided for in this Regulation are based on Opinion No 01/2018 11 
issued by the European Aviation Safety Agency (EASA) in accordance with Article 65 
of Regulation (EU)  2018/1139 , 
HAS ADOPTED THIS REGULATION:  
SECTION  1 
GENER AL PROVISIONS  
Article 1  
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 applicable to the ‘open’ category of UAS operations pursuant to 
Regulation (EU) …/… [IR]12 and UAS components  which are to be made available 
on the market . It also  establish es rules on the free movement  of UAS  in the Union.  
2. This Regulation lays also down rules for third -country UAS operators, when they 
condu ct a UAS operation falling within the ‘open’ or ‘specific’ category , as defined 
in Regulation (EU) …/… [IR] within the single European sky airspace.  
Article  2 
Scope  
1. This Regulation applies  to the following products:  
(a) UAS intended to be operated under the ru les and conditions applicable to the 
‘open’ category of UAS operations pursuant to Re gulation (EU) …/… [IR] , 
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  Regulation (EU) …/… [IR]  it belongs  to; 
(b) Components of the above UAS as set out in Part 6 of the Annex  to this 
Regulation . 
2. This Regulation also applies to operators that have their principal place of business, 
are established, or reside in a third country , if their UAS are operated in the Union . 
Article  3 
Definitions  
For the purposes of this Regulation, the following definitions  shall  apply:  
(1) ‘unmanned aircraft’ (UA) means any aircraft operating or designed to operate 
autonomously or to be piloted remotely without a pilot on board;  
                                                 
(11) EASA Opinion No 01/2018 ‘Introduction of a regulatory framework for the operation  
of unmanned aircraft systems in the ‘open ’ and ‘specific’ categories’ (RMT.0230), available at 
https://www.easa.europa.eu/document -library/opinions . 
(12) OJ reference to be added when the draft Commission Regulation laying down rules and pr ocedures for 
the operation of unmanned aircraft will be adopted. For referencing purposes, ‘ Regulation (EU) …/… 
[IR]’ is used in the proposed draft Regulation.   
EN 9  EN (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 the unmanned aircraft , the software or 
application provided with it  and the equipment to control it remotely;  
(4) ‘unmanned aircraft system (UAS) operator’ means any legal or natural person who 
operates or intends to operate one or more UAS;  
(5) ‘open’ category’ is a category of low risks UAS operation s that requires neither a 
prior authorisation by the competent authority  established under Regula tion …[IR] , 
nor a declaration by the UAS operator before the operation takes place;  
(6) ‘Union harmonisation legislation’ means any Union legislation harmonising the 
conditions for placing products on the market;  
(7) ‘accreditation’ means accreditation as defined in Article 2 (10) of Regulation (EC) No 
765/2008;  
(8) ‘conformity assessment’ means the process demonstrating whether the specified 
requirements relating to a product have been fulfilled;  
(9) ‘conformity assessment body’ means a body that performs conformity assess ment 
activities including calibration, testing, certification and inspection;  
(10) ‘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 pro viding for its affix ing; 
(11) ‘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;  
(12) ‘authorised representative’ means any natural or legal p erson established within the 
Union who has received a written mandate from a manufacturer to act on his behalf 
in relation to specified tasks;  
(13) ‘importer’ means any natural or legal person established within the Union who 
places a product from a third count ry on the Union market;  
(14) ‘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;  
(15) ‘economic operators’ means the manufacturer, the authorised representativ e of the 
manufacturer, the importer, and the distributor of the UAS;  
(16) ‘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 paym ent or free of charge;  
(17) ‘placing on the market’ means the first making available of a product  on the Union 
market;  
(18) ‘harmonised standard’ means a harmonised standard as defined in point (c) of Article 
2(1) of Regulation (EU) No 1025/2012;  
(19) ‘technical specifi cation’ means a document that establishes technical requirements to 
be fulfilled by a product, process or service;   
EN 10  EN (20) ‘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;  
(21) ‘market surveillance authority’ means an authority of a Member State responsible for 
carrying out market surveillance on its territory;  
(22) ‘recall’ means any measure aimed at achieving the return of a product that has 
already been made available to the end user;  
(23) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain 
from being made available on the market;  
(24) ‘single European sky airspace’ means airspace above the terr itory to which the 
Treaties apply, as well as any other airspace where Member States apply Regulation 
(EU) No 551/2004  of the European Parliament and of the Council13 in accordance 
with Article 1(3) of that Regulation;  
(25) ‘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;  
(26) ‘payload’ means any inst rument, mechanism, equipment, part, apparatus, 
appurtenance, or accessory, including communications equipment, that is installed in 
or attached to the aircraft, is not used or intended to be used in operating or 
controlling an aircraft in flight, and is no t part of an airframe, engine, or propeller;  
(27) ‘follow -me mode’ means a mode of operation of a UAS where the UA constantly 
follows a person or a device within a predetermined radius;  
(28) ‘remote identification  system ’ means a system that ensures the transmission  of 
information about  a UA in operation , including  the marking of the UA , so that this 
information  can be obtained without direct physical access to the UA;  
(29) ‘geo-awareness’ means a function that , based on the data provided by Member 
States , allows the detect ion a potential breach of airspace limitations by the pilot and 
provides sufficient information and an appropriate alert to take effective action to 
prevent that breach ; 
(30) ‘sound power level LWA’ means the A -weighted sound power in dB in relation to 1 
pW as defined in EN ISO 3744: 2010 ; 
(31) ‘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 equipme nt or from 
the average of a number of UA;  
(32) ‘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 ; 
                                                 
(13)  Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on 
the organisation and use of the airspace in the single European sky (OJ L 96, 31.3.2004, p. 20).   
EN 11  EN (33) ‘hovering’ means staying in the same position in the air .  [these are rather technical 
terms that are used only in the Annex; it would make more sense to included them in 
the relevant parts of the Annex]  
Article 4 
Requirements  
1. Products  shall meet the requirements  set out  in Part 1  to 6 of the Annex.  
2. Updates of the s oftware  of products  taking place after the making of such products 
available on the market, shall not affect the compliance of the product.  
 Article 5 
Free movement of products  
Member States shall not prohibit, restrict or impede, for the aspects covered by this 
Regulation, the making available on the market of products that comply with this Regulation.  
SECTION  2 
OBLIGATIONS OF ECONOM IC 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 
of Part 1 to 6 of  the Annex . 
2. Manufacturers shall draw up the technical documentation provided for Article 17 and 
carry out th e relevant conformity assessment procedure referred to in Article 13, or 
have it outsourced.  
Where compliance of the product with the requirements set in Part 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 Regulation. 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, invest igate, 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 shall ensure that their products bear  a type  and a unique serial number 
comp liant, when applicable , with the requirement defined in the corresponding Parts 
2 to 6 of the Annex  allowing their identification, and  that it is also provided on the 
packaging or a document accompanying it .  
EN 12  EN 6. Manufacturers shall indicate their name, registered trade name or registered 
trademark and the postal address at which they can be contacted on the product 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 ma nufacturer 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 instructions and 
information required by  Part 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 instructions and information, 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 addre ss 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 Regulation shall immediately 
take the correc tive 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 mad e 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 
Regulation, in a language which can be easily understood by that authority. They 
shall cooperate with that a uthority, at its request, on any action taken to eliminate the 
risks posed by the product which they have placed on the market.  
Article 7 
Authorised representatives  
1. A manufacturer may, by a written mandate, appoint an authorised representative.  
2. The obligat ions laid down in Article 6(1) and Article 6(2) shall not form part of the 
authorised representative’s mandate.  
3. An authorised representative shall perform the tasks specified in the mandate 
received from the manufacturer. The mandate shall allow the author ised 
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;   
EN 13  EN (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  
1. Importers shall only place products c ompliant with the requirements set out in this 
Regulation on the Union market.  
2. 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 accompanie d by the documents referred to in Article 6(8) and 
(9); 
(e) the manufacturer has complied with the requirements set out in Article 6(6) and 
(7). 
Where an importer considers or has reason s to believe that a product is not in 
conformity with the requirements set  out in Part 1 to 6  of the Annex , he 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.  
3. Importers shall indicate on the product their name, registered trade name or 
registered trademark and the postal address at which they can be contacted or, where 
that is not possible, on its packaging or in a document accompanying the product. 
The contact details shall be in a language easily understood by end users and market 
surveillance authorities.  
4. Importers shall ensure that the product is accompanied by the instructions and 
informati on required by Part 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 instructions and information, as well as any labelling, shall be clear, 
understandable and legible.  
5. Importers shall ensure that, while the product is under their responsibility, its storage 
or transport conditions do not jeopardise its compliance with the requirements set out 
in Article 4. 
6. When deemed appropriate with regard to the risks presented by a product, importers 
shall, in order to protect the health and safety of end users and third parties, carry out 
sample testing of products made available on the market, investigate, and, if 
necessary, keep a register of complaints, of non-conforming  of products and product 
system, and shall keep distributors informed of any such monitoring.   
EN 14  EN 7. Importers who consider or have reason to believe that a product which they have 
placed on the market is not  in conformity with the applicable Union harmonisation 
legislation shall immediately take the corrective measures necessary to bring that 
product into conformity, to withdraw it or recall it, if appropriate. Furthermore, 
where the product presents a risk, importers 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  and of any corrective measures taken.  
8. Importers shall, for 10 years after the product has been placed on the market, keep a 
copy of the EU declaration of conformity at the disposal of the market surveillance 
authorities and ensure that the technical documentation can be made available to 
those a uthorities, upon request.  
9. Importers shall, further to a reasoned request from the competent national authority, 
provide it with all the information and documentation in paper or electronic form 
necessary to demonstrate the conformity of the product in a la nguage 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.  
Article 9 
Obligations of distributors  
1. When making a product available on the  Union  market, distributors shall act with 
due care in relation to the requirements set out in this Regulation.  
2. Before making a product available on the market, distributors shall verify that the 
product bears the CE m arking and, when relevant, the UA class identification label  
and the indication of the sound power level , is accompanied by the documents 
referred to in Article 6(8) and ( 9), and that the manufacturer and the importer have 
complied with the requirements se t out in Article 6(6) and (7) and Article 8(3). 
 
Distributors shall ensure that the product is accompanied by the instructions and 
information required by Parts 1 to 6 of the Annex in a language which can be easily 
understood by consumers and other end use rs, as determined by the Member State 
concerned. Such instructions and information, 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 re quirements 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.  
3. Distributors shall ensure that, while a product is under their responsibility, its storage 
or transport conditions do not jeopardise its compliance with the requirements set out 
in Article 4. 
4. Distri butors who consider or have reason s to believe that a product which they have 
made available on the market is not in conformity with the applicable Union 
harmonisation legislation shall make sure that the corrective measures necessary to 
bring that product  into conformity, to withdraw it or recall it, if appropriate, are 
taken. Furthermore, where the product presents a risk, distributors shall immediately  
EN 15  EN inform the market surveillance authorities of the Member States in which they made 
the product availabl e on the market to that effect, giving details, in particular, of the 
non-compliance  and of any corrective measures taken.  
5. Distributors shall, further to a reasoned request from the competent national  
authority, provide it with all the information and docu mentation in paper or 
electronic form necessary to demonstrate the conformity of the product. They shall 
cooperate with that authority, at its request, on any action taken to eliminate the risks 
posed by the product which they have made available on the ma rket. 
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 
Regulation, and shall be subject to the obligations of manufacturer s under Article 6, where 
they place a product on the market under his name or trademark or modifies the product 
already placed on the market in such a way that compliance with this Regulation may be 
affected.  
Article 11 
Identification of economic operators  
1. Econ omic 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.  
2. Economic operators shall be able to pre sent the information referred to in paragraph  
1 for 10 years after they have been supplied with the product and for 10 years after 
they have supplied the product.  
SECTION  3 
CONFORMITY OF THE PRO DUCT  
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 o r parts 
thereof set out in Part 1 to 6  of the Annex . 
Article 13 
Conformity assessment procedures  
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 Part 1 to 6  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 are the following:   
EN 16  EN (c) internal production con trol set out in Part 7 of the Annex , excepted when 
assessing the compliance of a product with the requirements set out in Parts 2, 
3 or 4 of the Annex , under 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;  
(d) EU-type examination followed by conformity to type based on internal 
production control set out in Part 8 of the Annex ; 
(e) conformity based  on full quality assurance 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  
1. The EU declaration of conformity referred to in Article 6(9) shall state that 
compliance of the product with the requirements set out in Part 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 Article 6(9) 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 la nguages 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 com pliance of the product with the requirements laid down in 
this Regulation.  
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.   
EN 17  EN 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 , and, when relevant, the UA class identification label shall be 
affixed vi sibly, legibly and indelibly to the product . The UA class identification label 
shall be affixed on the right side of the CE marking and have a similar size.  
2. The indication of the sound power level shall be affixed visibly, legibly and indelibl y 
on the UA unless that is not possible or not warranted on account of the size of the 
product.  
3. The CE marking , the UA class identification label  and the indication of the sound 
power level  shall also be affixed visibly and legibly to the packaging and to the 
user’s manual.  
4. The CE marking  and, when relevant, 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 and the UA class identification label 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 . 
6. The identification number of the notified body shall be affixed by the notified body 
itself or, under its instructions, by t he manufacturer or his authorised representative.  
7. 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  
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 Part 1 to 6  of the Annex . It shall, at lea st, 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 documentati on 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 o r the importer within a specified period in order to 
verify compliance of the product with the requirements set out in Part 1 to 6  of the 
Annex  which applies to it .  
EN 18  EN SECTION  4 
NOTIFICATION OF CONFO RMITY ASSESSMENT BOD IES 
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 Regulation.  
Article 19 
Notifying authorities  
1. Member States shall designate a notifying authority that shall be responsible for 
setting up and carrying out the necessary procedures for the assessment and 
notification of conformity assessment bodies and the monitoring of notified bodies, 
including compliance with Article 2 3. 
2. Member States may decide that the asses sment and monitoring referred to in 
paragraph 1 shall be carried out by a national accreditation body within the meaning 
of Regulation (EC) No 765/2008.  
3. Where the notifying authority delegates or otherwise entrusts the assessment, 
notification or monitorin g referred to in paragraph 1 to a body which is not a 
governmental entity, that body shall be a legal entity and shall comply mutatis 
mutandis with the requirements laid down in Article 20. In addition, it shall have 
arrangements to cover liabilities arisi ng out of its activities.  
4. The notifying authority shall take full responsibility for the tasks performed by the 
body referred to in paragraph 3.  
Article 20 
Requirements relating to notifying authorities  
1. 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 
conform ity 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 safegua rd 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.   
EN 19  EN Article 21 
Information obligation on notifying authorities  
1. Member States shall inform the Commission of their procedures for the assessment 
and notification of conformity assessment bodies and the monitoring of notified 
bodies, and of any changes thereto.  
2. The Commission shall make that information publicly available.  
Article 22 
Requirements rel ating to notified bodies  
1. For the purposes of notification, a conformity assessment body shall meet the 
requirements laid down in paragraphs 2 to 11.  
2. A conformity assessment body shall be established under national law of a Member 
State and have legal perso nality.  
3. A conformity assessment body shall be a third -party body independent of the 
organisation it assesses.  
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.  
4. A conformity assessment body, its top -level management and the pe rsonnel 
responsible for carrying out the conformity assessment tasks shall not be the 
designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of 
the product which they assess, nor the representative of any of those parties. This 
shall not preclude the use of assessed product that is necessary for the operations of 
the conformity assessment body or the use of such product for personal purposes.  
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 en gage 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 sha ll ensure that the activities of their subsidiaries or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their 
conformity assessment activities.  
5. Conformity assessment bodies and their personnel shall carry out the conformity 
assessment activities with the highest degree of professional integrity and the 
requisite technical competence in the specific field and shall be free from all 
pressures and inducements, particularly financial, which might influence their 
judgement or the results of their conformity assessment activities, especially as 
regards persons or groups of persons with an interest in the results of those activities.  
6. A conformity assessment body shall be capable of carrying out all the conformity 
assessment tasks ass igned to it by Part 8 or 9  of the Annex  in relation to which it has  
EN 20  EN been notified, whether those tasks are carried out by the conformity assessment body 
itself or on its behalf and under its responsibility.  
At all times and for each conformity assessment p rocedure 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 conf ormity 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 tha t 
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 appr opriate manner and shall have access to all necessary equipment 
or facilities.  
7. 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;  
(b) satisfactory knowledge of the requirements of the assessments they carry out 
and adequate authority to carry out those assessments;  
(c) appropriate knowledge and understanding of the requirements, of the 
applicable harmonised standards and of the relevant provisions of Union 
harmonisation legislation;  
(d) the ability to draw up EU -type examination certificates or quality system 
approvals, records and reports demonstrating that assessments have been 
carried out.  
8. The impartiality of the conformity assessment bodies, their top -level management 
and of the personnel responsible for carrying out the conformity assessment tasks 
shall be guaranteed.  
The remuneration of the top -level man agement and of the personnel responsible for 
carrying out the conformity assessment tasks of a conformity assessment body shall 
not depend on the number of assessments carried out or on the results of those 
assessments.  
9. Conformity assessment bodies shall t ake out liability insurance unless liability is 
assumed by the Member State in accordance with national law, or the Member State 
itself is directly responsible for the conformity assessment.  
10. The personnel of a conformity assessment body shall observe profe ssional secrecy 
with regard to all information obtained in carrying out their tasks under Parts  8 and 9   
EN 21  EN of the Annex  or any provision of national law giving effect to them, except in 
relation to the competent authorities of the Member State in which its ac tivities are 
carried out. Proprietary rights shall be protected.  
11. Conformity assessment bodies shall participate in, or ensure that their personnel 
responsible for carrying out the conformity assessment tasks are informed of, the 
relevant standardisation ac tivities, the regulatory activities in the area of UAS and 
frequency planning, and the activities of the notified body coordination group 
established under the relevant Union harmonisation legislation, and shall apply as 
general guidance the administrative  decisions and documents produced as a result of 
the work of that group.  
Article 23 
Presumption of conformity of notified bodies  
Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in the relevant harmonised standards  or parts thereof, the references of which have been 
published in the Official Journal of the European Union , it shall be presumed to comply with 
the requirements set out in Article 22 in so far as the applicable harmonised standards cover 
those requiremen ts. 
Article 24 
Subsidiaries of and subcontracting by notified bodies  
1. Where a notified body subcontracts specific tasks connected with conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or 
the subsidiary meets the requirements set out in Article 22 and shall inform the 
notifying authority accordingly.  
2. Notified bodies shall take full responsibility for the tasks performed by 
subcontractors or subsidiaries, wherever these are established.  
3. Activities may be subcontract ed or carried out by a subsidiary only with the 
agreement of the client.  
4. Notified bodies shall keep at the disposal of the notifying authority the relevant 
documents concerning the assessment of the qualifications of the subcontractor or the 
subsidiary and  the work carried out by them under Parts  8 and 9  of the Annex . 
Article 25 
Application for notification  
1. A conformity assessment body shall submit an application for notification to the 
notifying authority of the Member State in which it is established.  
2. The application for notification shall be accompanied by a description of the 
conformity assessment activities, the conformity assessment module or modules, and 
the product for which that body claims to be competent, as well as by an 
accreditation certificate  issued by a national accreditation body attesting that the 
conformity assessment body fulfils the requirements laid down in Article 22.  
EN 22  EN Article 26 
Notification procedure  
1. Notifying authorities may only notify conformity assessment bodies which have met 
the requirements laid down in Article 22. 
2. They shall notify conformity assessment bodies to the Commission and the other 
Member States using the electronic notification tool developed and managed by the 
Commission.  
3. The notification shall include full details of the conformity assessment activities, the 
conformity assessment module or modules, and the product concerned and the 
relevant accreditation certification.  
4. The body concerned may perform the activities of a notified body only where no 
objections are rais ed by the Commission or the other Member States within 2 weeks 
of a notification.  
5. Only such a body shall be considered a notified body for the purposes of this 
Regulation.  
6. The notifying authority shall notify the Commission and the other Member States of 
any subsequent relevant changes to the notification.  
Article 27 
Identification numbers and lists of notified bodies  
1. The Commission shall assign an identification number to a notified body.  
2. It shall assign a single such number even where the body is notifie d under several 
Union acts.  
3. The Commission shall make publicly available the list of the bodies notified under 
this Regulation, including the identification numbers that have been assigned to them 
and the activities for which they have been notified.  
The C ommission shall ensure that the list is kept up to date.  
Article 28 
Changes to notifications  
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Article 2 2, or that it fails to  fulfil its 
obligations, the notifying authority shall restrict, suspend or withdraw the 
notification as appropriate, depending on the seriousness of the failure to meet those 
requirements or fulfil those obligations. It shall immediately inform the Commis sion 
and the other Member States accordingly.  
2. In the event of restriction, suspension or withdrawal of the notification, or where the 
notified body has ceased its activity, the notifying Member State shall take 
appropriate steps to ensure that the files of  that body are either processed by another 
notified body or kept available for the responsible notifying and market surveillance 
authorities at their request.   
EN 23  EN Article 29 
Challenge of the competence of notified bodies  
1. The Commission shall investigate all ca ses where it has doubts, or doubt is brought 
to its attention, about the competence of a notified body or the continued fulfilment 
by a notified body of the requirements and responsibilities to which it is subject.  
2. The notifying Member State shall provide the Commission, on request, with all the 
information relating to the basis for the notification or the maintenance of the 
competence of the notified body concerned.  
3. The Commission shall ensure that all sensitive information obtained in the course of 
its in vestigations is treated confidentially.  
4. Where the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for notification, it shall inform the notifying Member State 
accordingly and request it to take the necessary cor rective measures, including de -
notification if necessary.  
Article 30 
Operational obligations of notified bodies  
1. Notified bodies shall carry out conformity assessments in accordance with the 
conformity assessment procedures provided in Parts  8 and 9  of the Annex . 
2. Conformity assessments shall be carried out in a proportionate manner, avoiding 
unnecessary burdens for economic operators. Conformity assessment bodies shall 
perform their activities taking 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.  
In doing so, they shall nevertheless respect the degree of rigour and the level of 
protection required for the co mpliance of the UA or UAS with this Regulation.  
3. Where a notified body finds that the requirements set out in Parts  1 to 6 of the Annex  
or in corresponding harmonised standards or other technical specifications have not 
been met by a manufacturer, it shall require the manufacturer to take appropriate 
corrective measures and shall not issue an EU -type examination certificate or a 
quality system approval.  
4. Where, in the course of the monitoring of conformity following the issue of an EU -
type examination certifi cate or a quality system approval, a notified body finds that a 
product no longer complies, it shall require the manufacturer to take appropriate 
corrective measures and shall suspend or withdraw the EU -type examination 
certificate or the quality system ap proval if necessary.  
5. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, suspend or withdraw any EU -type examination 
certificates or quality system approvals, as appropriate.  
Article 31 
Appeal against decisions of notified bodies  
Notified bodies shall ensure that a transparent and accessible appeal procedure against their 
decisions is available.   
EN 24  EN Article 32 
Information obligation on notified bodies  
1. Notified bodies shall inform the notifying autho rity of the following:  
(a) any refusal, restriction, suspension or withdrawal of an EU -type examination 
certificate or a quality system approval in accordance with the requirements of 
Partes 8 and 9  of the Annex ; 
(b)  any circumstances affecting the scope of, or c onditions for, notification;  
(c)  any request for information which they have received from market surveillance 
authorities regarding conformity assessment activities;  
(d)  on request, conformity assessment activities performed within the scope of 
their notificati on and any other activity performed, including cross -border 
activities and subcontracting.  
2. Notified bodies shall, in accordance with the requirements of Parts  8 and 9  of the 
Annex , provide the other bodies notified under this Regulation carrying out simila r 
conformity assessment activities covering the same categories of UA or UAS with 
the relevant information on issues relating to negative and, on request, positive 
conformity assessment results.  
3. Notified bodies shall fulfil information obligations under Parts 8 and 9  of the Annex . 
Article 33 
Exchange of experience  
The Commission shall provide for the organisation of exchange of experience between the 
Member States’ national authorities responsible for notification policy.  
Article 34 
Coordination of notified  bodies  
1. The Commission shall ensure that appropriate coordination and cooperation between 
bodies notified under this Regulation are put in place and properly operated in the 
form of a sectorial group of notified bodies.  
2. Member States shall ensure that the bodies notified by them participate in the work 
of that group, directly or by means of designated representatives . 
SECTION  5 
UNION MARKET SURVEILL ANCE , CONTROL OF PRODUCTS ENTERING THE UNION 
MARKET AND UNION SAFEGUARD PROCE DURE  
Article 35 
Market surveilla nce 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 Article 15(3) and Articles 16 to 26 of 
Regulation (EU) No 765/2008.  
2. Member States shall organise and perform control of the products that enter the 
Union market in accordance with Articles 15(5) and Articles 27 , 28 and  29 of 
Regulation (EU) No 765/2008.   
EN 25  EN 3. Member States shall ensure that their market surveillance and border control 
authorities cooperate with the competent authorities designated under Article 9 of 
Regulation (EU) …/… [IR] on safety matters and shall establish appropriate 
communication and coordination mechanisms between them, making the best use of 
the information con tained  in the occurrence reporting system defined under 
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.  
Article 36 
Procedure for dealing  with products presenting a risk at national level  
1. Where the market surveillance authorities of one Member State have taken action 
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have 
sufficient reason to believe that a product presents a risk to the health or safety of 
persons or to other aspects of public interest protection covered by this Regulation, 
they shall carry out an evaluation in relation to the product concerned, covering all 
applicable requirements laid down in this  Regulation. The relevant economic 
operators shall cooperate as necessary with the market surveillance authorities for 
that purpose.   
Where, in the course of the evaluation referred to in the first subparagraph, the 
market surveillance authorities find tha t the product does not comply with the 
requirements laid down in this Regulation, they shall, without delay, require the 
relevant economic operator to take all appropriate corrective actions to bring the 
product into compliance with those requirements, to withdraw the product from the 
market, or to recall it within a reasonable period, commensurate with the nature of 
the risk, as they may prescribe.  
The market surveillance authorities shall inform the relevant notified body 
accordingly.  
Article 21 of Regula tion (EC) No 765/2008 shall apply to the measures referred to in 
the second subparagraph of this paragraph.  
2. Where the market surveillance authorities consider that non -compliance is not 
restricted to their national territory, they shall inform the Commissi on and the other 
Member States of the results of the evaluation and of the actions which they have 
required the economic operator to take.  
3. The economic operator shall ensure that all appropriate corrective action is taken in 
respect of all products concern ed that it has made available on the market throughout 
the Union.  
4. Where the relevant economic operator does not take adequate corrective action 
within the period referred to in the second subparagraph of paragraph 1, the market 
surveillance authorities sha ll take all appropriate provisional measures to prohibit or 
                                                 
(14) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the 
reporting, analysis and follow -up of occurrences in civ il aviation, amending Regulation (EU) No 
996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the 
European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) 
No 1330/2007 (OJ L 122, 2 4.4.2014, p. 18).   
EN 26  EN restrict the product being made available on their national market, to withdraw the 
product from that market or to recall it.  
The market surveillance authorities shall inform the Commission and th e other 
Member States, without delay, of those measures.  
5. The information referred to in paragraph 4 shall include all available details, in 
particular the data necessary for the identification of the non -compliant product, the 
origin of the product, the na ture of the non -compliance alleged and the risk involved, 
the nature and duration of the national measures taken and the arguments put forward 
by the relevant economic operator. In particular, the market surveillance authorities 
shall indicate whether the non-compliance is due to either of the following:  
(a) failure of the product to meet the requirements set out in Article 4; or 
(b) shortcomings in the harmonised standards referred to in Article 12. 
6. Member States other than the Member State initiating the procedur e under this 
Article shall, without delay, inform the Commission and the other Member States of 
any measures adopted and of any additional information at their disposal relating to 
the non -compliance of the product concerned, and, in the event of disagreem ent with 
the adopted national measure, of their objections.  
7. Where, within 3 months of receipt of the information referred to in paragraph 5, no 
objection has been raised by either a Member State or the Commission in respect of a 
provisional measure taken b y a Member State, that measure shall be deemed 
justified.  
8. Member States shall ensure that appropriate restrictive measures, such as withdrawal 
of the product from the market, are taken in respect of the product concerned without 
delay.  
Article 37 
Union saf eguard procedure  
1. Where, on completion of the procedure set out in Article 36(3) and (4), objections 
are raised against a measure taken by a Member State, or where the Commission 
considers a national measure to be contrary to Union legislation, the Commissi on 
shall without delay enter into consultation with the Member States and the relevant 
economic operator or operators and shall evaluate the national measure. On the basis 
of the results of that evaluation, the Commission shall decide whether the national 
measure is justified or not.  
The Commission shall address its decision to all Member States and shall 
immediately communicate it to them and the relevant economic operator or 
operators.  
2. If the national measure is considered justified, all Member States sha ll take the 
necessary measures to ensure that the non -compliant product is withdrawn or 
recalled from their market, and shall inform the Commission accordingly. If the 
national measure is considered unjustified, the Member State concerned shall 
withdraw th at measure.  
3. Where the national measure is considered justified and the non -compliance of the 
product is attributed to shortcomings in the harmonised standards referred to in point  
EN 27  EN (b) of Article 35(5) of this Regulation, the Commission shall apply the proc edure 
provided for in Article 11 of Regulation (EU) No 1025/2012.  
Article 38 
Compliant product which presents a risk  
1. Where, having carried out an evaluation under Article 36(1), a Member State finds 
that although the product is in compliance with this Regu lation, it presents a risk to 
the health or safety of persons or to other aspects of public interest protection 
covered by this Regulation, it shall require the relevant economic operator to take all 
appropriate measures to ensure that the product concerne d, when placed on the 
market, no longer presents that risk, to withdraw the product from the market or to 
recall it within a reasonable period, commensurate with the nature of the risk, as it 
may prescribe.  
2. The economic operator shall ensure that correctiv e action is taken in respect of all the 
products concerned that he has made available on the market throughout the Union.  
3. The Member State shall immediately inform the Commission and the other Member 
States. That information shall include all available det ails, in particular the data 
necessary for the identification of the product concerned, the origin and the supply 
chain of product, the nature of the risk involved and the nature and duration of the 
national measures taken.  
4. The Commission shall, without delay, enter into consultation with the Member States 
and the relevant economic operator or operators and shall evaluate the national 
measures taken. On the basis of the results of that evaluation, the Commission shall 
decide whether the national measure i s justified or not and, where necessary, propose 
appropriate measures.  
5. The Commission shall address its decision to all Member States and shall 
immediately communicate it to them and the relevant economic operator or 
operators.  
Article 39 
Formal non -compli ance  
1. Without prejudice to Article 36, where a Member State makes one of the following 
findings  concerning products covered by this regulation , it shall require the relevant 
economic operator to put an end to the non -compliance concerned:  
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) 
No 765/2008 or of Article 14 or Article 15 of this Regulation;  
(b) the CE marking has not been affixed;  
(c) the identification number of the notified body, where the conformity 
assessmen t procedure set out in Part 9 of the Annex  is applied, has been affixed 
in violation of Article 16 or has not been affixed;  
(d) the indication of the sound power level if required has not been affixed;  
(e) the EU declaration of conformity has not been drawn up;  
(f) the EU declaration of conformity has not been drawn up correctly;  
(g) technical documentation is either not available or not complete;   
EN 28  EN (h) manufacturer's or importer's name, registered trade name or registered 
trademark or postal address are missing  
2. Where the non -compliance referred to in paragraph 1 persists, the Member State 
concerned shall take all appropriate measures to restrict or prohibit the product being 
made available on the market or ensure that it is withdrawn or recalled from the 
market.  
SECTION  6 
THIRD -COUNTRY UAS  OPERATORS  
Article 40 
Third -country UAS operators  
1. UAS operators that have their principal place of business, are established, or reside in 
a third country, shall comply with Regulation (EU) .../... [IR] for the purpose of UAS 
operations within t he single European sky airspace.  
2. The competent authority for the third -country UAS operator is the competent 
authority of the Member State where the UAS operator intends to operate.  
3. By way of derogation from paragraph 1, a certificate of the remote pilot c ompetency 
or the UAS operator  in accordance with Article 5  of Regulation (EU) .../... [IR] , or an 
equivalent document, may be recognised by the competent authority for the purpose 
of operation within, to, and out of the Union provided that:  
(a) the third count ry asked for such recognition;  
(b) the certificate of the remote pilot competency or the UAS operator’s certificate 
are valid documents of the State of issue; and  
(c) the Commission, after consultation of EASA, has ensured  that the requirements 
on the basis of which such certificates have been issued provide the same level 
of safety as this Regulation does.  
SECTION  7 
FINAL AND TRANSITIONA L PROVISIONS  
Article 4 1 
Technical guidelines  
In order to facilitate the implementation of this Regulation, the Commission shall draw up 
non-binding  guidelines in consultation with the stakeholders.  
Article 4 2 
Entry into force  
This Regulation shall enter into force on the  twentieth  day following that of its  publication in 
the Official Journal  of the European Union.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 29  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER