Manufacturers must carry out a risk analysis and ensure that their products meet specific standards to achieve system reliability before placing them on the EU market.
This procedure is called conformity assessment and is carried out during the design and production phases. The product conformity assessment includes testing, inspection, and certification. The responsible that the conformity assessment is carried out is the manufacturer.
Within the drone certification, an integral product conformity assessment is the main concept considered.
Declaration of Conformity (DoC)
Once the assessment has been completed, the manufacturer or the authorized representative must draw up a declaration of conformity (DoC).
The declaration of conformity must include information about:
- the product
- the legislation according to which it is issued
- the manufacturer or its authorized representative
- the notified body involved if applicable
- a reference to harmonized standards or other normative documents if applicable
Assessing the conformity of your drone
In the drone sector there are several modules to assess the conformity of equipment:
- Module A: internal production control
Covers both design and production.
The manufacturer himself ensures the conformity of the products to the legislative requirements (no EU-type examination).
- Module B: EU-type examination
Covers design.
It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated.
- Module C: Conformity to EU-type based on internal production control
The manufacturer must internally control its production to ensure product conformity against the EU-type approved under module B.
- Module H: conformity based on full quality assurance
Covers both design and production.
The manufacturer operates a full quality assurance system to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system.
In Module H1 the notified body assesses the quality system and the product design and issues an EU design examination certificate too. The EU design examination certificate attests that the conformity of the product’s design has been checked and certified by a notified body.
The EU-design examination certificate must not be confused with the EU-type examination certificate of module B that attests to the conformity of a specimen representative of the production envisaged so the conformity of the products may be checked against this specimen.
Resource: (European Commission, s.f.) (OECD Library, s.f.)
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