RED notified body trigger workflow

Do not begin with the question, "Do we need a notified body?" Begin with the requirement row. Identify whether the issue belongs to Article 3(1)(a), Article 3(1)(b), Article 3(2), an activated Article 3(3) requirement, or Article 3(4), then check whether the exact OJEU-cited harmonised standard or cited part covers that requirement for the finished radio equipment configuration.

This distinction matters because RED Article 17 treats Article 3(1) and Article 3(4) differently from Article 3(2) and Article 3(3). For Article 3(2) or Article 3(3), Annex III or Annex IV is ordinarily required when the manufacturer does not apply the relevant OJEU-cited harmonised standards, applies them only in part, or no such standards exist. Article 43c provides a conditional exception for designated crisis-relevant equipment during an activated internal market emergency. A standard may cover one essential requirement without covering another, so make the decision requirement by requirement.

Apply the trigger test requirement by requirement. For Article 3(1) and Article 3(4), RED Article 17 permits internal production control under Annex II even when the manufacturer demonstrates conformity by means other than harmonised standards. A notified body may still be chosen, but the absence of a harmonised standard is not the trigger by itself for Article 3(1) or Article 3(4).

For Article 3(2) and Article 3(3), the trigger is stricter. If the manufacturer has not applied OJEU-cited harmonised standards, has applied them only in part, or no such standards exist, the radio equipment must be submitted for the affected essential requirements to Annex III or Annex IV.

When Annex III is selected, the evidence file should show that the manufacturer applied to a single notified body, provided technical documentation and supporting evidence, and did not lodge the same application with another notified body. EU-type examination assesses the adequacy of the radio equipment's technical design through examination of the technical documentation and supporting evidence, without examination of a specimen. If the type meets the applicable requirements, the notified body issues an EU-type examination certificate.

Keep the certificate evidence tied to the product type and to the exact Article 3 aspects covered. A certificate is weak evidence if the file does not show the tested configuration, the standards or technical specifications used, the conditions for validity, and the changes that would require additional approval.

When Annex IV is selected, the evidence is broader than a one-time certificate. The manufacturer applies for assessment of the quality system for the radio equipment concerned, keeps the notified body informed of intended quality-system changes, and remains under notified-body surveillance.

The CE marking evidence also changes under Annex IV: RED Article 20 requires the notified body's identification number to follow the CE marking where Annex IV is applied. The record should therefore connect the approved quality-system scope, notified-body surveillance records, and CE marking artwork or label controls.

The final workflow output should be a short trigger record that a product, regulatory, quality, legal, procurement, or market-surveillance reviewer can follow without reconstructing the project history. It should explain the yes, no, or escalate answer for each affected Article 3 requirement.

Avoid closing the workflow with a meeting note. The record should link the requirement, standards coverage, route decision, notified-body scope, certificate or quality-system evidence, EU declaration text, CE marking controls, and unresolved assumptions.