According to module B+C as a Notified Body (NB), ALTER conducts the conformity assessment.
Conformity assessment and examination according to module B+C: Module B is the Europe type-examination and module C is the conformity to type based on internal production control per Annex II.
What is conformity assessment according to module B+C
Within the drone CE marking process, an integral product conformity assessment is the main concept considered to achieve our system’s reliability. The product conformity assessment includes testing, inspection, and certification.
Once the assessment has been completed, the manufacturer or the authorized representative must draw up a declaration of conformity (DoC).
What is notified body (NB)
A Notified Body is a conformity assessment body that has been notified by a member state of the European Commission and ratified by a Notifying Body to carry out conformity assessment activities for a given 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.
Module B+C: Conformity assessment and examination
According to module B (Europe type-examination)
In this module, a Notified Body examines the technical documentation to assess the technical design of the product and to verify that it meets the applicable requirements for unmanned aircraft systems and direct remote identification add-ons set out in Parts 1 to 6, 16, and 17 of Delegated Regulation (EU) 2019/945.
Moreover, in the case of the specimen, the Notified Body has to verify that it has been manufactured according to the technical documentation and identify the elements which have been designed under the applicable provisions of the harmonized standards and the technical specifications, as well as the elements which have been created without applying the requirements of those standards. It is essential to carry out tests to check whether the solutions have been applied correctly. It is also important to perform tests where the solutions in harmonized standards have not been applied to check if the resolutions adopted by the manufacturer meet the requirements of the legislation.
Once these verifications are done, the Notified Body has to elaborate an evaluation report on the activities carried out and their results. If the model meets the requirements, the Notified Body will issue an EU-type examination to the manufacturer.
The Notified Body should be informed of any changes performed to the product by the manufacturer to analyze them and check if the changes affect any Regulation requirements, in which case the affected requirement should be assessed again. In addition, the notified body must inform the manufacturer of changes in the Regulation or in the implementing rules that may affect the conformity of his product with them.
NBs shall inform its notifying authority and other NBs about EU-type certificates that it has issued or suspended. In addition, the manufacturer shall keep a copy of the EU-type examination certificate and additional related information at the disposal of the national authorities for 10 years.
According to Module C (Conformity to type based on internal production control)
The manufacturer ensures that the products conform to the type described in the EU-type examination certificate, are manufactured according to the Delegated Regulation (EU) 2019/945, and have the CE Marking affixed.
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