1.   This Regulation lays down the requirements for the design and manufacture of unmanned aircraft systems (‘UAS’) intended to be operated under the rules and conditions defined in Implementing Regulation (EU) 2019/947 and of remote identification add-ons. It also defines the type of UAS whose design, production and maintenance shall be subject to certification.

2.   It also establishes rules on making UAS intended for use in the ‘open’ category and remote identification add-ons available on the market and on their free movement in the Union.

3.   This Regulation also lays down rules for third-country UAS operators, when they conduct a UAS operation pursuant to Implementing Regulation (EU) 2019/947 within the single European sky airspace.

1.   Chapter II of this Regulation applies to the following products:

2.   Chapter III of this Regulation applies to UAS operated under the rules and conditions applicable to the ‘certified’ and ‘specific’ categories of UAS operations pursuant to Implementing Regulation (EU) 2019/947.

3.   Chapter IV of this Regulation applies to UAS operators that have their principal place of business, are established, or reside in a third country, if the UAS are operated in the Union.

4.   This Regulation does not apply to UAS intended to be exclusively operated indoors.

1.   The products referred to in paragraph 1 of Article 2 shall meet the requirements set out in Parts 1 to 6 of the Annex.

2.   UAS that are not toys within the meaning of Directive 2009/48/EC shall comply with the relevant health and safety requirements set out in Directive 2006/42/EC only in relation to risks other than those linked to the safety of the UA flight.

3.   Any updates of software of the products that have already been made available on the market may be made only if such updates do not affect the compliance of the product.

1.   Products shall only be made available on the market if they satisfy the requirements of this Chapter and do not endanger the health or safety of persons, animals or property.

2.   Member States shall not prohibit, restrict or impede, for the aspects covered by this Chapter, the making available on the market of products that comply with this Chapter.

1.   When placing their product on the Union market, manufacturers shall ensure that it has been designed and manufactured in compliance with the requirements set out in Parts 1 to 6 of the Annex.

2.   Manufacturers shall draw up the technical documentation provided for in Article 17 and carry out the relevant conformity assessment procedure referred to in Article 13 or have it outsourced.

Where compliance of the product with the requirements set out in Parts 1 to 6 of the Annex has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

3.   Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the product has been placed on the market.

4.   Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Chapter. Changes in product design, characteristics or software, and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls and shall keep distributors informed of any such monitoring.

5.   Manufacturers of UAS shall ensure that the UA bears a type within the meaning of Decision 768/2008/EC and a unique serial number allowing for its identification, and if applicable, compliant with the requirements defined in the corresponding Parts 2 to 4 of the Annex. Manufacturers of remote identification add-ons shall ensure that the remote identification add-on bears a type and a unique serial number allowing for their identification and compliant with the requirements defined in Part 6 of the Annex. In both cases, manufacturers shall ensure that a unique serial number is also affixed to the EU declaration of conformity or to the simplified EU declaration of conformity referred to in Article 14.

6.   Manufacturers shall indicate on the product their name, registered trade name or registered trademark, website address and the postal address at which they can be contacted or, where that is not possible, on its packaging, or in a document accompanying it. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be indicated in a language easily understood by end-users and market surveillance authorities.

7.   Manufacturers shall ensure that the product is accompanied by the manual and information notice required by Parts 1 to 6 of the Annex in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such manual and information notice, as well as any labelling, shall be clear, understandable and legible.

8.   Manufacturers shall ensure that each product is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity. Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained.

9.   Manufacturers who consider or have reason to believe that products which they have placed on the market are not in conformity with this Chapter shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Where the product presents a risk, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance, of any corrective measures taken and of the results thereof.

10.   Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product with this Chapter, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product which they have placed on the market.

1.   A manufacturer may, by a written mandate, appoint an authorised representative.

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.

2.   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:

1.   Importers shall only place products compliant with the requirements set out in this Chapter on the Union market.

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

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 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, website 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 manual and information notice required by Parts 1 to 6 of the Annex in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. That manual and information notice, 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 recalls, and shall keep distributors informed of any such monitoring.

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 authorities, 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 language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the product which they have placed on the market.

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 Chapter.

2.   Before making a product available on the market, distributors shall verify that the product bears the CE marking and, when applicable, the UA class identification label and the indication of the sound power level, is accompanied by the documents referred to in paragraphs 7 and 8 of Article 6 and that the manufacturer and the importer have complied with the requirements set out in paragraphs 5 and 6 of Article 6 and in paragraph 3 of Article 8).

Distributors shall ensure that the product is accompanied by the manual and information notice required by Parts 1 to 6 of the Annex in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. That manual 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.

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.   Distributors who consider or have reasons 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 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.

5.   Distributors 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. 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 market.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 least, contain the elements set out in Part 10 of the Annex.

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

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

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

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 24.

2.   Member States may decide that the assessment 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 monitoring 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 arising out of its activities.

4.   The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

1.   A notifying authority shall:

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.

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 personality.

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 personnel 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 the 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 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.

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 assigned to it by Part 8 or 9 of the Annex in relation to which it has 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 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 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.

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

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 management 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 take 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 professional secrecy with regard to all information obtained in carrying out their tasks under Parts 8 and 9 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 activities 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 activities, 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.

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 subcontracted 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.

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.

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 raised 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 Chapter.

6.   The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

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 notified 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 Commission shall ensure that the list is kept up to date.

1.   Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 22, 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 Commission 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.

1.   The Commission shall investigate all cases 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 investigations 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 corrective measures, including de-notification if necessary.

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 compliance of the UA or UAS with this Chapter.

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 certificate 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 approval 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.

1.   Notified bodies shall inform the notifying authority of the following:

2.   Notified bodies shall, in accordance with the requirements of Parts 8 and 9 of the Annex, provide the other bodies notified under this Chapter carrying out similar 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.

1.   The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Chapter are put in place and properly operated in the form of a sectorial group of notified bodies.

2.   Notified bodies shall participate in the work of that group, directly of by means of designated representatives.

1.   Member States shall organise and perform surveillance of the products that are placed on the Union market in accordance with paragraph 3 of Article 15 and Articles 16 to 26 of Regulation (EC) No 765/2008.

2.   Member States shall organise and perform control of the products that enter the Union market in accordance with paragraph 5 of Article 15 and Articles 27, 28 and 29 of Regulation (EC) No 765/2008.

3.   Member States shall ensure that their market surveillance and border control authorities cooperate with the competent authorities designated under Article 17 of Implementing Regulation (EU) 2019/947 on safety matters and shall establish appropriate communication and coordination mechanisms between them, making the best use of the information contained in the occurrence reporting system defined in Regulation (EU) No 376/2014 of the European Parliament and of the Council (14) and the information systems defined in Articles 22 and 23 of Regulation (EC) No 765/2008.

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 Chapter, they shall carry out an evaluation in relation to the product concerned, covering all applicable requirements laid down in this Chapter. 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 that the product does not comply with the requirements laid down in this Chapter, 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 Regulation (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 Commission 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 concerned 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 shall take all appropriate provisional measures to prohibit or 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 the 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 nature 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:

6.   Member States other than the Member State initiating the procedure 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 disagreement with the adopted national measure, of their objections.

7.   Where, within three 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 by 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.

1.   Where, on completion of the procedure set out in paragraphs 3 and 4 of Article 36, 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 Commission 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 shall 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 that 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 (b) of paragraph 5 of Article 36 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

1.   Where, having carried out an evaluation under paragraph 1 of Article 36, a Member State finds that, although the product is in compliance with this Chapter, it presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Chapter, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, 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 corrective 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 details, 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 is 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.

1.   Without prejudice to Article 36, where a Member State makes one of the following findings concerning products covered by this Chapter, it shall require the relevant economic operator to put an end to the non-compliance concerned:

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.

1.   The design, production and maintenance of UAS shall be certified if the UAS meets any of the following conditions:

2.   A UAS subject to certification shall comply with the applicable requirements set out in Commission Regulations (EU) No 748/2012 (15), (EU) 2015/640 (16) and (EU) No 1321/2014 (17).

3.   Unless it needs to be certified in accordance with paragraph 1, a UAS used in the ‘specific’ category shall feature the technical capabilities set out in the operational authorisation issued by the competent authority or in the standard scenario defined in Appendix 1 to the Annex of Implementing Regulation (EU) 2019/947 or as defined by the Light UAS Operator Certificate (LUC) pursuant to Part C of the Annex of Implementing Regulation (EU) 2019/947.

1.   UAS operators that have their principal place of business, are established, or reside in a third country, shall comply with Implementing Regulation (EU) 2019/947 for the purpose of UAS operations within the single European sky airspace.

2.   The competent authority for the third-country UAS operator shall be the competent authority of the first Member State where the UAS operator intends to operate.

3.   By way of derogation from paragraph 1, a certificate of the remote pilot competency or UAS operator in accordance with Implementing Regulation (EU) 2019/947, 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:

1.   A total amount of EUR 209 904 000 shall be allocated from the general budget of the Union to cover costs referred to in Article 85(1) of Regulation (EU) 2018/1240.

2.   The amount referred to in paragraph 1 shall be taken from the amount of EUR 791 000 000 earmarked for the development of IT systems referred to under Article 5(5)(b) of Regulation (EU) No 515/2014.

1.   The amount referred to in Article 1(1) shall be used as follows:

2.   The amount referred to in paragraph 1(c) shall be allocated in equal shares to the Member States.

1.   Operations shall be classified as UAS operations in the ‘open’ category only where the following requirements are met:

2.   UAS operations in the ‘open’ category shall be divided in three sub-categories in accordance with the requirements set out in Part A of the Annex.

1.   Where one of the requirements laid down in Article 4 or in Part A of the Annex is not met, a UAS operator shall be required to obtain an operational authorisation pursuant to Article 12 from the competent authority in the Member State where it is registered.

2.   When applying to a competent authority for an operational authorisation pursuant Article 12, the operator shall perform a risk assessment in accordance with Article 11 and submit it together with the application, including adequate mitigating measures.

3.   In accordance with point UAS.SPEC.040 laid down in Part B of the Annex, the competent authority shall issue an operational authorisation, if it considers that the operational risks are adequately mitigated in accordance with Article 12.

4.   The competent authority shall specify whether the operational authorisation concerns:

5.   Where the UAS operator submits a declaration to the competent authority of the Member State of registration in accordance with point UAS.SPEC.020 laid down in Part B of the Annex for an operation complying with a standard scenario as defined in Appendix 1 to that Annex, the UAS operator shall not be required to obtain an operational authorisation in accordance with paragraphs 1 to 4 of this Article and the procedure laid down in paragraph 5 of Article 12 shall apply.

6.   An operational authorisation or a declaration shall not be required for:

1.   Operations shall be classified as UAS operations in the ‘certified’ category only where the following requirements are met:

2.   In addition, UAS operations shall be classified as UAS operations in the ‘certified’ category where the competent authority, based on the risk assessment provided for in Article 11, considers that the risk of the operation cannot be adequately mitigated without the certification of the UAS and of the UAS operator and, where applicable, without the licensing of the remote pilot.

1.   UAS operations in the ‘open’ category shall comply with the operational limitations set out in Part A of the Annex.

2.   UAS operations in the ‘specific’ category shall comply with the operational limitations set out in the operational authorisation as referred to in Article 12 or the authorisation as referred to in Article 16, or in a standard scenario defined in Appendix 1 to the Annex as declared by the UAS operator.

This paragraph shall not apply where the UAS operator holds an LUC with appropriate privileges.

UAS operations in the ‘specific’ category shall be subject to the applicable operational requirements laid down in Commission Implementing Regulation (EU) No 923/2012 (5).

3.   UAS operations in the ‘certified’ category shall be subject to the applicable operational requirements laid down in Implementing Regulation (EU) No 923/2012 and Commission Regulations (EU) No 965/2012 (6) and (EU) No 1332/2011 (7).

1.   Remote pilots operating UAS in the ‘open’ category shall comply with the competency requirements set in Part A of the Annex.

2.   Remote pilots operating UAS in the ‘specific’ category shall comply with the competency requirements set out in the operational authorisation by the competent authority or in the standard scenario defined in Appendix 1 to the Annex or as defined by the LUC and shall have at least the following competencies:

3.   Remote pilots operating in the framework of model aircraft clubs or associations shall comply with the minimum competency requirements defined in the authorisation granted in accordance with Article 16.

1.   The minimum age for remote pilots operating a UAS in the ‘open’ and ‘specific’ category shall be 16 years.

2.   No minimum age for remote pilots shall be required:

3.   Member States may lower the minimum age following a risk-based approach taking into account specific risks associated with the operations in their territory:

4.   Where a Member State lowers the minimum age for remote pilots, those remote pilots shall only be allowed to operate a UAS on the territory of that Member State.

5.   Member States may define a different minimum age for remote pilots operating in the framework of model aircraft clubs or associations in the authorisation issued in accordance with Article 16.

1.   An operational risk assessment shall:

2.   The description of the UAS operation shall include at least the following:

3.   The assessment shall propose a target level of safety, which shall be equivalent to the safety level in manned aviation, in view of the specific characteristics of UAS operation.

4.   The identification of the risks shall include the determination of all of the below:

5.   The identification of the possible mitigation measures necessary to meet the proposed target level of safety shall consider the following possibilities:

6.   The robustness of the proposed mitigating measures shall be assessed in order to determine whether they are commensurate with the safety objectives and risks of the intended operation, particularly to make sure that every stage of the operation is safe.

1.   The competent authority shall evaluate the risk assessment and the robustness of the mitigating measures that the UAS operator proposes to keep the UAS operation safe in all phases of flight.

2.   The competent authority shall grant an operational authorisation when the evaluation concludes that:

3.   When the operation is not deemed sufficiently safe, the competent authority shall inform the applicant accordingly, giving reasons for its refusal to issue the operational authorisation.

4.   The operational authorisation granted by the competent authority shall detail:

5.   Upon receipt of the declaration referred to in paragraph 5 of Article 5, the competent authority shall:

1.   When an UAS operator intends to conduct an operation in the ‘specific’ category for which an operational authorisation has already been granted in accordance with Article 12, and which is intended to take place partially or entirely in the airspace of a Member State other than the Member State of registration, the UAS operator shall provide the competent authority of the Member State of intended operation with an application including the following information:

2.   Upon receipt of the application set out in paragraph 1, the competent authority of the Member State of intended operation shall assess it without undue delay and provide the competent authority of the Member State of registration and the UAS operator with a confirmation that the updated mitigation measures referred to in point (b) of paragraph 1 are satisfactory for the operation at the intended location. Upon receipt of that confirmation, the UAS operator may start the intended operation and the Member State of registration shall record the updated mitigation measures that the UAS operator has to apply in the operational authorisation issued in accordance with Article 12.

3.   When an UAS operator intends to conduct an operation in the ‘specific’ category for which a declaration has been made in accordance with paragraph 5 of Article 5, and which is intended to take place partially or entirely in the airspace of a Member State other than the Member State of registration, the UAS operator shall provide the competent authority of the Member State of the intended operation with a copy of the declaration submitted to the Member State of registration, as well as a copy of the confirmation of receipt and completeness.

1.   Member States shall establish and maintain accurate registration systems for UAS whose design is subject to certification and for UAS operators whose operation may present a risk to safety, security, privacy, and protection of personal data or environment.

2.   The registration systems for UAS operators shall provide the fields for introducing and exchanging the following information:

3.   The registration systems for unmanned aircraft whose design is subject to certification shall provide the fields for introducing and exchanging the following information:

4.   Member States shall ensure that registration systems are digital and interoperable and allow for mutual access and exchange of information through the repository referred to in Article 74 of Regulation (EU) 2018/1139.

5.   UAS operators shall register themselves:

6.   UAS operators shall register themselves in the Member State where they have their residence for natural persons or where they have their principal place of business for legal persons and ensure that their registration information is accurate. A UAS operator cannot be registered in more than one Member State at a time.

Member States shall issue a unique digital registration number for UAS operators and for the UAS that require registration, allowing their individual identification.

The registration number for UAS operators shall be established on the basis of standards that support the interoperability of the registration systems;

7.   The owner of an unmanned aircraft whose design is subject to certification shall register the unmanned aircraft.

The nationality and registration mark of an unmanned aircraft shall be established in line with ICAO Annex 7. An unmanned aircraft cannot be registered in more than one State at a time.

8.   The UAS operators shall display their registration number on every unmanned aircraft meeting the conditions described in paragraph 5.

1.   When defining UAS geographical zones for safety, security, privacy or environmental reasons, Member States may:

2.   On the basis of a risk assessment carried out by the competent authority, Member States may designate certain geographical zones in which UAS operations are exempt from one or more of the ‘open’ category requirements.

3.   When pursuant to paragraphs 1 or 2 Member States define UAS geographical zones, for geo awareness purposes they shall ensure that the information on the UAS geographical zones, including their period of validity, is made publicly available in a common unique digital format.

1.   Upon request by a model aircraft club or association, the competent authority may issue an authorisation for UAS operations in the framework of model aircraft clubs and associations.

2.   The authorisation referred to in paragraph 1 shall be issued in accordance with any of the following:

3.   The authorisation referred to in paragraph 1 shall specify the conditions under which operations in the framework of the model aircraft clubs or associations may be conducted and shall be limited to the territory of the Member State in which it is issued.

4.   Member States may enable model aircraft clubs and associations to register their members into the registration systems established in accordance with Article 14 on their behalf. If this is not the case, the members of model aircraft clubs and associations shall register themselves in accordance with Article 14.

1.   Each Member State shall designate one or more entities as the competent authority for the tasks referred to in Article 18.

2.   Where a Member State designates more than one entity as a competent authority it shall:

1.   The competent authorities of the Member States and market surveillance and control authorities referred to in Article 36 of Delegated Regulation (EU) 2019/945 shall cooperate on safety matters and establish procedures for the efficient exchange of safety information.

2.   Each UAS operator shall report to the competent authority on any safety-related occurrence and exchange information regarding its UAS in compliance with Regulation (EU) No 376/2014.

3.   The European Union Aviation Safety Agency (‘the Agency’) and the competent authorities shall collect, analyse and publish safety information concerning UAS operations in their territory in accordance with Article 119 of Regulation (EU) 2018/1139 and its implementing acts.

4.   Upon receiving any of the information referred to in paragraphs 1, 2 or 3, the Agency and the competent authority shall take the necessary measures to address any safety issues on the best available evidence and analysis, taking into account interdependencies between the different domains of aviation safety, and between aviation safety, cyber security and other technical domains of aviation regulation.

5.   Where the competent authority or the Agency takes measures in accordance with paragraph 4, it shall immediately notify all relevant interested parties and organisations that need to comply with those measures in accordance with Regulation (EU) 2018/1139 and its implementing acts.

1.   Authorisations granted to UAS operators, certificates of remote pilot competency and declarations made by UAS operators or equivalent documentation, issued on the basis of national law, shall remain valid until 1 July 2021.

2.   By 1 July 2021 Member States shall convert their existing certificates of remote pilot competency and their UAS operator authorisations or declarations, or equivalent documentation, including those issued until that date, in accordance with this Regulation.

3.   Without prejudice to Article 14, UAS operations conducted in the framework of model aircraft clubs and associations shall be allowed to continue in accordance with relevant national rules and without an authorisation in accordance with Article 16 until 1 July 2022.

1.   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 July 2020.

2.   Paragraph 5 of Article 5 shall apply as from the date on which Appendix 1 of the Annex is amended so that it contains the applicable standard scenarios. Member States may in accordance with paragraph 5 of Article 5 accept declarations by UAS operators based on national standard scenarios, if those scenarios meet the requirements of point UAS.SPEC.020 of the Annex until this Regulation is amended to include the standard scenario in Appendix 1 of the Annex.

3.   Paragraph 3 of Article 15 shall apply from 1 July 2021.