If you want to place on the EU market a model of drone that is intended for use in the open category or in a standard scenario (in other words a drone bearing a class identification label) or a remote identification module to be added to an existing drone, you must ensure the product conforms to the requirements defined by Regulation (EU) 2019/945 – known as the EU Drone Rules. Compliance involves both the design and production phases.
Standards for unmanned aircraft systems (UAS) — a road to compliance with Regulation (EU) 2019/945
Harmonised standards are currently developed by CEN/TC 471 ‘UAS’ (EN 4709-00x series). Standard EN4709-002 has already been published. The full set of standards should be available before the end of 2024. Once their reference will have been published in the Official Journal of the European Union (OJEU) in 2025, these standards will provide presumption of conformity to the requirements set by Regulation (EU) 2019/945.
In the meantime, the draft standards may however help manufacturers to define appropriate ways to demonstrate the conformity of their products. European actors wishing to get a copy of the latest draft European Standard (prEN), will be able to obtain it after registration in one of the national mirroring committees of CEN/TC 471 ‘UAS’ (full list of CEN Members).
Conformity assessment procedures (or modules) to ensure a drone’s compliance
To demonstrate their product’s conformity to the regulatory requirements, manufacturers are required to prepare a technical documentation and use one of the conformity assessment procedures defined by the Regulation (EU) 2019/945. Depending on the product, up to three procedures are available to perform the demonstration of conformity under Regulation (EU) 2019/945, i.e. Module A, Module B+C and Module H. The table below shows which ones are available for each category of product:
Module A — Declaration of conformity
Module A is a procedure by which the manufacturer himself ensures the products’ conformity to the legislative requirements (not available for class identification labels C1, C2 and C3 UASs). Module A (see Part 7 of the Annex to Regulation (EU) 2019/945) covers both design and production.
Module A — Design phase
When Module A is used, the manufacturer carries out, in the design phase, the adequate analysis and tests and develops a technical documentation to demonstrate the conformity of the model’s design to the applicable requirements.
Module A — Production phase
In the production phase, the manufacturer takes all necessary measures so that the manufacturing process and its monitoring ensure compliance of each individual manufactured product with the technical documentation. The manufacturer draws up a written EU Declaration of Conformity for each product model according to Part 11 of the Annex to Regulation (EU) 2019/945. The manufacturer then affixes the CE mark on each individual product. Finally, the manufacturer includes, with each product, a physical copy of the Declaration of Conformity (or the simplified Declaration of Conformity as per Part 12 of the Annex to Regulation (EU) 2019/945) on which he affixes the serial number of the product, except for C0 UAS.
Modules B + C — Conformity through a notified body
Module B requires the involvement of one of the conformity assessment organisations that must be notified under Regulation (EU) 2019/945 (see a list of ‘notified bodies’ at EUROPA – European Commission – Growth – Regulatory policy - SMCS). The bodies attest the conformity of the product’s design. Module B must be followed by Module C, by which the manufacturer ensures the conformity of the product to the EU type approved under Module B.
When Modules B + C (see Part 8 of the Annex to Regulation (EU) 2019/945) are used, manufacturers need to follow this procedure:
- They select one (and only one) notified body to whom they submit the technical documentation that they have prepared, including supporting evidence for the adequacy of the design, together with a specimen representative of the production envisaged.
- The notified body examines the technical design and the specimen, and verifies and attests that they meet the requirements by issuing an EU-type examination certificate.
- After receiving the EU-type examination certificate, manufacturers must establish an internal control process of their production to ensure the conformity of the manufactured product to the EU-type examination.
- Manufacturers draw up a written EU Declaration of Conformity for each product model according to Part 11 of the Annex to Regulation (EU) 2019/945.
- Manufacturers can affix the CE mark on each individual product.
- Manufacturers include, with each individual product, a physical copy of the Declaration of Conformity (or the simplified Declaration of Conformity as per Part 12 of the Annex to Regulation (EU) 2019/945) that includes the serial number of the product, except for C0 UAS.
Module H — Conformity based on full quality assurance
Module H (see Part 9 of the Annex to Regulation (EU) 2019/945) can only be used by manufacturers that operate a full quality assurance system to ensure conformity to legislative requirements. In this case, the notified body (a list of which can be accessed in the previous section) assesses the quality system of the manufacturer.
For more information, please consult the ‘Blue Guide’ on the implementation of EU product rules 2022.
Requirements if a drone has multiple class identification labels
A UAS may have multiple class identification labels (e.g. C0 and C1) if the manufacturer demonstrates that the UAS complies with all the requirements that are defined for each class identification label.
Placing on the market drones with C5 and C6 class identification labels
When manufacturers place on the market a new model with a C5 or C6 class identification label, independently from the method (module) used to demonstrate the conformity of the drone, they must inform the national market surveillance authority of their place of residence (please find the list at DocsRoom - European Commission (europa.eu)) when they place. To this end, they should send the Declaration of Conformity of the drone to the authority.
Essential legislation for placing a drone on the market
Please be aware that several product harmonisation legislations, beyond Regulation (EU) 2019/945, may apply to your product when placed or made available on the EU market. For instance, the following:
- Directive 2014/53/EU on radio equipment,
- Directive 2006/42/EC on machinery,
- Directive 2012/19/EU on waste electrical and electronic equipment (WEEE),
- Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS),
- Directive 1999/5/EC on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity,
- Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility.
This list is, however, not exhaustive and it is the manufacturer’s responsibility to identify all applicable pieces of legislation. Once conformity to all applicable requirements has been demonstrated, manufacturers shall draw up an EU Declaration of Conformity and affix the CE marking on their product.
Listing of drones with compliance assurance on EASA’s website
In order to support the UAS market, EASA is providing a list of products that are intended for use in the Open Category - Civil Drones | EASA (europa.eu). This list does not presume compliance of the products listed. However, EASA will ensure that products that have been identified as non compliant by market surveillance authorities are removed from the list. Manufacturers that are willing to have their product listed, may send an email to drones [at] easa.europa.eu (drones[at]easa[dot]europa[dot]eu), attaching a copy of their Declaration of Conformity.
