EU Radio Equipment Directive conformity assessment and CE marking

Article 17 provides three routes: Annex II internal production control, Annex III EU-type examination followed by conformity to type based on internal production control, and Annex IV full quality assurance. The route depends on which Article 3 requirements are being assessed and whether OJEU-published harmonised standards have been applied in full for the relevant requirements.

For Article 3(1) health and safety, EMC, and Article 3(4) charging-capability requirements where applicable, the manufacturer may use Annex II, Annex III, or Annex IV. For Article 3(2) efficient spectrum use and Article 3(3) additional requirements, Annex II remains available only where the relevant OJEU-cited harmonised standards are applied for the requirements being assessed. If those standards do not exist, are not applied, or are applied only in part, the product must use Annex III or Annex IV for those requirements. This route test is made per essential requirement, not once for the product as a whole.

A notified body is involved when the selected RED route is Annex III or Annex IV. Annex III uses Module B EU-type examination by a notified body, followed by Module C internal production control against the approved type. Annex IV uses an approved full quality-assurance system under notified-body responsibility.

The notified-body record should be tied to the exact product type and the specific Article 3 requirements covered. For Annex III, keep the EU-type examination certificate, annexes, additions, technical documentation submitted, supporting evidence, and the manufacturer's production-control evidence. For Annex IV, keep the approved quality-system documentation, change approvals, audit reports, visit reports, test reports where performed, and the notified body's decisions.

The RED technical documentation must let a reviewer assess conformity with the applicable requirements. Annex V calls for product descriptions, photographs or illustrations, marking and internal layout, software or firmware versions affecting compliance, user and installation information, design and manufacturing drawings, explanations, standards mapping, other technical specifications, design calculations, examinations, test reports, and Article 10(2) and Article 10(10) explanations.

The EU declaration of conformity is the manufacturer's responsibility statement and must be kept continuously updated. It must follow the Annex VI model structure, identify the radio equipment, list Directive 2014/53/EU and any other applicable Union harmonisation legislation, identify standards or technical specifications, name notified-body intervention where applicable, and describe relevant accessories, components, and software where they allow the radio equipment to operate as intended.

CE marking follows successful conformity assessment. Under RED Articles 19 and 20, the CE marking must be visible, legible, and indelible on the radio equipment or data plate unless that is not possible or not warranted because of the nature of the equipment; it must also be visible and legible on the packaging. The mark must be affixed before the radio equipment is placed on the market.

The CE file should show the same product identity across the scope memo, Article 3 matrix, standards list, test evidence, notified-body records, technical documentation, declaration, packaging, instructions, restriction information, and final label artwork. If the cybersecurity delegated requirements, common-charger rules, or other Union CE-marking laws apply, keep their evidence separated by legal basis while using one coherent release pack.