CE MarkingRED

EU Radio Equipment Directive (RED) Conformity Assessment and CE

Make CE evidence a controlled release artifact.

Output: route decision + technical file + EU DoC with traceability to tests and standards.

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Author

Sorena AI

Published

Feb 21, 2026

Updated

Feb 21, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 21, 2026

Updated Feb 21, 2026

Overview

RED conformity assessment is about proving compliance, not stating it. The fastest path is to (1) use harmonised standards where possible, (2) choose the right conformity assessment module early, and (3) structure the technical documentation so you can answer market surveillance questions quickly.

Section 1

Choose the route: how teams decide correctly

Your route depends on standards coverage, product complexity, and whether you need third-party assessment for parts of the design.

Make route selection explicit in a short decision record: what standards you use, what gaps exist, and whether you involve a notified body.

For Article 3(1)(a) and 3(1)(b), manufacturers may use Annex II internal production control even without harmonised standards
For Article 3(2) and 3(3), Annex II is available only when OJ-listed harmonised standards are fully applied for the relevant requirements
If Article 3(2) or 3(3) coverage is incomplete, partly applied, or absent, use Annex III or Annex IV with a notified body
Cybersecurity (EU) 2022/30: treat cybersecurity evidence as part of the technical documentation when applicable

Section 2

Technical documentation (what it must do)

The technical file should be a retrievable story: product facts -> requirements -> standards/tests -> results -> declarations.

Structure it by product type and variant so you don't rebuild it for every SKU.

Product description + intended use + variants
Design evidence: schematics, BOM, firmware versions, radios/bands/protocols
Requirements mapping: Article 3 requirements to verification methods
Test evidence: EMC, spectrum, safety, and (if applicable) cybersecurity verification
Change control: what changed since last release and why it doesn't break compliance

Section 3

EU Declaration of Conformity (DoC): treat it like code

The DoC is not a one-time PDF. It is a controlled compliance artifact that must match the shipped product and the standards/tests you used.

Build DoC generation and maintenance into release processes.

List applicable legal acts (RED, plus any activated delegated acts) and the standards used
Ensure model identifiers and variant coverage match what is shipped
Version and retain the DoC and technical documentation for 10 years after the radio equipment is placed on the market
Update the DoC when design, firmware, radio characteristics, or standards references change

Section 4

Notified bodies: when they matter and how to use them effectively

Notified body engagement is slowest when the evidence pack is incomplete. Prepare a review-ready package.

Decide early which parts of the file are in scope for third-party assessment.

Plan lead time: notified body schedules can affect your launch date, especially where Article 3(2) or 3(3) cannot rely fully on harmonised standards
Prepare a review pack: requirements matrix, standards list, test reports, risk documentation, and change history
Keep alignment: the notified body view should match the DoC and product shipped

Section 5

Market surveillance readiness (your fastest ROI)

Most enforcement pain is evidence retrieval, not technical non-compliance. Build a retrieval-first technical file.

Run a drill: can you assemble the pack in hours, not weeks?

Evidence vault per product family and variant
Authority response playbook: owners, timelines, and export formats
Internal pre-audit checks: scope memo, DoC, standards references, test coverage

Recommended next step

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Assessment workflow

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Primary sources