Introduction
The purpose of this article is to introduce the conformity assessment modules for drones. Regulation (EU) 2019/945 defines four types of conformity assessment procedures: Modules A, B, C, and H. The class category of a drone influences the applicable conformity assessment module; furthermore, the class category depends on the UAS’s mass and other technical parameters. This hierarchical system determines the conformity assessment route, including the involvement of a Notified Body and the applicable requirements.
What is the conformity assessment and why is it important?
Manufacturer’s obligation is to ensure conformity (design and production) and they shall draw up the technical documentation and carry out or have the relevant conformity assessment procedures carried out. The conformity assessment regarding the drone’s compliance with the requirements of UAS Classes, that is based on the 2019/945 Regulation. In case of UAS the Regulation defines four different routes of the conformity assessment modules. The selection of a specific module or routes affects the drone certification cost and determines whether the involvement of a Notified Body or self-declaration is required.
Review of the conformity assessment modules
The conformity assessment procedures under Regulation (EU) 2019/945 are the following:
- Module A – Internal production control: For unmanned aircraft C0, C4, C5, C6 and add-ons only.
- Module B + C – EU-type examination and conformity to type based on internal production control (for all classes).
- Module H – Conformity based on full quality assurance (for all classes).
In cases of module B, C and H a Notified Body must be involved, furthermore in cases of UA Classes: C1, C2 and C3, it is mandatory to involve a Notified Body in the UAS conformity assessment procedure.
Module A: Internal production control
In the case of drones, Module A, the internal product control might be chosen by the manufacturers to conduct conformity assessments on their own. This module applies exclusively to UA Class C0, C4, C5, C6 and to remote ID add-ons. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points, like Technical documentation, Manufacturing and CE Marking and EU DoC. Furthermore, the manufacturer ensures and declares on their sole responsibility that the products concerned satisfy the requirements set out for the relevant UA Classes and DRI add-ons. See more details in Commission Delegated Regulation (EU) 2019/945, 2019, CHAPTER 2, SECTION 2, Article 6.
In addition to the (EU) 2019/945 Regulation manufacturers shall identify all the harmonised legislation applicable to their product and make sure to fulfill those requirements as well, among others RED, EMCD, etc.
Module B: EU Type Examination
EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of the product and verifies and attests that the technical design of the product meets the applicable requirements set out in UA Class C0 to C6 and DRI add-ons.
EU-type examination shall be carried out by an assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting application, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type).
According to the Regulation (EU) 2019/945 for UA Class C1, C2 and C3 the intervention of Notified Body (NoBo) is mandatory, and Module A is not an option for the manufacturer.
Where the type meets the requirements of this Regulation, the NoBo shall issue an EU-type examination certificate to the manufacturer.
In case of CerTrust, our company typically completes type examination (testing, assessment, and certification process) within 30 working days, provided that the product and its documentation meet the requirements of the regulation and standards. We carry out the examination with great care and under close supervision, in full compliance with current regulations.
Module C: Conformity to type based on internal production control
Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations (Manufacturing and CE Marking and EU Doc), and ensures and declares that the products concerned are in conformity with the type described in the EU- type examination certificate and satisfy the applicable requirements of this Regulation. Relevant Classes: C0, C1, C2, C3, C4, C5, C6 and Add-ons.
Module H: Full quality assurance
Conformity based on full quality assurance is the conformity assessment procedure whereby manufacturers fulfil the obligations, like manufacturing, CE Marking and EU DoC. Moreover, they ensure and declare on their sole responsibility that the product concerned satisfies the applicable requirements of UA Classes C0 to C6 and Add-ons. The intervention of a Notified Body is mandatory in case of module H and Notified Bodies shall carry out periodic audits to supervise the quality assurance system of the manufacturer.
In the case of Module H, the manufacturer shall lodge an application for the assessment of his quality system with the notified body of their choice, for the product(s) concerned. The quality system shall ensure compliance of the product(s) with the requirements of this Regulation. The Notified Body shall assess the quality system to determine whether it satisfies the requirements. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. Surveillance is under the responsibility of the Notified Body. The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities.
What Module should I choose?
In basically, the manufacturers have the possibility to choose from different conformity assessment routes. But in some cases, the UA Class determines the conformity assessment Modules.
- For UA Class C0 the manufacturers can select Module A, B+C and H.
- For class C1 only Module B+C or H is applicable.
- For class C2 only Module B+C or H is applicable.
- For class C3 only Module B+C or H is applicable.
- For UA Class C4 the manufacturers can choose Module A, B+C and H.
- For UA Class C5 the manufacturers can select Module A, B+C and H.
- For UA Class C6 the manufacturers can select Module A, B+C and H.
- For direct remote ID add-ons the manufacturers can select Module A, B+C and H.
According to the above list and the Regulation (EU) 2019/945 for UA Class C1, C2 and C3the intervention of Notified Body (NoBo) is mandatory.
Hints:
When harmonized standards exist, the use of harmonized standards for the conformity assessment evaluation under module A is compulsory and therefore the involvement of a Notified Body is advisable when the manufacturers would outsource the testing according to the harmonized standards to a 3rd party laboratory, because in such case at the end of the process the manufacturers would not only obtain a test report according to the harmonized standard, but also an EU-Type Examination from a Notified Body.
For small scale production and few UAS types manufactured, module A or B+C might be the better choice, whilst in case of high scale production, high innovation and many different types of UAS manufactured, the module H may be a more suitable and economically better choice.
What does it mean? If the intervention of NoBo is happening, the product will obtain an EU Type Examination certificate or quality assurance system certificate and it will provide higher trust on EU Market.
How do I choose a Notified Body?
The main aspects to select a Notified Body for the UAS field are testing and certification activities coverage, experience in testing of specific functions, availability and reachability, prices, and leading time.
CerTrust (NB 2806) has the necessary accreditation and notification scope to provide our customers with testing and certification services both in open (C0 to C4) and specific (C5, C6) category as well as for directi remote ID add-ons. Our testing and certification process is based on the standards of the European Union. We have a highly equipped testing laboratory and environment. Our colleagues have experiences among others in specific testing, like tether, Follow-me mode, Geo-awareness. So, we are well prepared for the most critical tests too. Our leading time is typically 30 working days, it covers all processes from quotation to evaluation.
Summary
Select of the conformity assessment route is a complex decision. It requires significant regulatory and technical knowledge. A comprehensive overview would help to choose the right UA category and conformity Module for manufacturers, drone start-ups and distributors. Our company as Notified Body is able to support the process of How to get drone certification. We can give information about the selection of Modules, involving Notified Body, testing and assessment process and requirements, and we are ready to help to get the EU Type-examination.
The conformity assessment Modules are a critical business decision, which influences the reliability of the product, the cost of the certification or the need of the NoBo. Finally, the right and professional execution of the conformity assessment procedure provides the lawful product in the EU market. If you would like to obtain more information, please see our other topics: UAS Type Certification – Do You Need It?, What Tests Does a Drone Need for EU Market Access?, Drone CE Marking – Mandatory Requirements.
