EU Radio Equipment Directive Notified Body Route Selection

First split the assessment by essential requirement. Article 17(2) allows the manufacturer to demonstrate Article 3(1) and Article 3(4) compliance through Annex II internal production control, Annex III EU-type examination followed by conformity to type, or Annex IV full quality assurance.

For Article 3(2) and Article 3(3), internal production control is available only when the manufacturer has applied harmonised standards whose references are published in the Official Journal for the requirements being assessed. If those standards are not applied, are only partly applied, or do not exist for the relevant requirement, Article 17(4) removes Annex II for that part of the assessment and requires either Annex III or Annex IV.

Annex III is the product-design route: a single notified body of the manufacturer's choice examines the adequacy of the technical design through the technical documentation and supporting evidence, without examination of a specimen. When the type meets the applicable RED requirements, the notified body issues an EU-type examination certificate; the manufacturer then uses internal production control to ensure each item conforms to the approved type and applicable requirements.

Annex IV is the quality-system route: the manufacturer uses an approved quality system for design, manufacture, final inspection, and testing, and the notified body assesses and surveils that system. Annex IV also affects marking because the CE marking is followed by the notified body's identification number when Annex IV is applied.

The route-selection memo should be readable without project history. It should show the product configuration assessed, the Article 3 requirements in scope, the harmonised-standard status for each requirement, and the reason Annex II, Annex III, or Annex IV was selected.

Annex III evidence should include the EU-type examination application package, the technical documentation, supporting evidence, the notified body's evaluation outcome, the EU-type examination certificate and annexes if issued, and later approvals for modifications that affect conformity or certificate validity. Annex IV evidence should include the quality-system documentation, technical documentation for each radio equipment type, notified-body decisions, audit reports, visit reports, and approved quality-system changes.

The most common mistake is treating a voluntary certificate or a generic test report as a substitute for the RED conformity-assessment route. The Commission warns that voluntary or other additional certificates are not a recognised means to prove compliance unless specific legislation provides for them.

A second mistake is assuming that any standard with a familiar title gives full presumption of conformity. Route selection depends on the references published in the Official Journal and on the exact Article 3 requirement covered. A partly applied or non-OJEU specification can still be useful evidence, but it does not by itself preserve the Annex II route for Article 3(2) or 3(3).