EU Drone Regulation Guidance 2019/945: Obligations of manufacturers

Article 6 & 7 – Obligations relating to manufactures

Regulation (EU) 2019/945: Obligations of manufacturers

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

SECTION 2

Obligations of economic operators

Article 6

Obligations of manufacturers

  1. When placing their product on the Union market, manufacturers shall ensure that it has been designed and manufactured in compliance with the requirements set out in Parts 1 to 6 of the Annex.
  2. Manufacturers shall draw up the technical documentation provided for in Article 17 and carry out the relevant conformity assessment procedure referred to in Article 13 or have it outsourced.

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

  1. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the product has been placed on the market.
  2. 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.

  1. 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.
  2. 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.
  3. 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 that can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such manual and information notice and any labeling shall be clear, understandable, and legible.
  4. 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.
  5. 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.
  6. 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 that 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 7

Authorized representatives

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

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

  1. An authorized representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorized 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 market surveillance or border control authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the product;

 

(c)

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

Alter Technology, with more than 35 years in the aerospace sector and strong and wide expertise in the drones field, can help you solve your doubts about regulation and ensure the safety of your drone to place in the European market with the CE marking and Class Label.

Key points of European Regulation 2019/945

Notified Body in the conformity assessment.

Instructions and information on CE marking and class label