Q&A: Notified Bodies (NBs) act within the scope of European Directives

Q.// European standards are not yet fully defined, how can there be
Notified Bodies designated for the conformity assessment of UAS when it is not
known what the process will be?

A.// The COMMISSION DELEGATED REGULATION (EU) 2019/945 does not require harmonized standards for compliance, which means that a Notified Body can use other procedures to assess the essential requirements included in a directive.

In general, Notified Bodies (NBs) act within the scope of European Directives/Regulations when the manufacturer does not use harmonized standards (either because they do not exist or because the manufacturer chooses not to use them). What the NB assesses, in this case, is that the applicable essential requirements are met and that the level of safety is equivalent to that which exists using harmonized standards where these exist.

A testing laboratory demonstrates its competence by accreditation according to EN ISO 17025, which sets out the testing and calibration laboratories; however, this standard does not affect the certification body that must comply with EN ISO 17065.

The requirements to be fulfilled by Notified Bodies are reflected in Article 22 of, which are the same as those mentioned in the EN as mentioned above ISO 17065 Standard.

These requirements are impartiality, insurance, independence from the assessed organization, etc.

In turn, the product must comply with the requirements that appear in the annex of COMMISSION DELEGATED REGULATION (EU) 2019/945, depending on whether it is a drone (vehicle) or a remote identification accessory and depending on its class in the first case.

The conformity assessment of the product can be carried out according to modules A, B + C, and H. Module A can only be used if harmonized standards exist.

ALTER TECHNOLOGY carries out this assessment according to module B, EU type-examination as a Notified Body. This module examines the product’s technical design and verifies that the product complies with the applicable requirements. It also ensures that the manufacturing and monitoring process guarantees the conformity of the manufactured product with the approved type and affixes the CE marking and drawing up the corresponding declaration of conformity.

ALTER TECHNOLOGY has recently obtained accreditation to assess conformity according to COMMISSION DELEGATED REGULATION (EU) 2019/945) intended to be operated in the open category and remote identification accessories; this is a new service in addition to the others related to testing, safety, and regulation. So, if you want the experience of a company with more than 30 years in the aerospace sector, providing you with confidence and guarantee, do not hesitate to contact us.

Key points of European Regulation 2019/945

Notified Body in the conformity assessment.

Instructions and information on CE marking and class label