- RED harmonised-standard citations can include notices that limit presumption of conformity for specific parameters, clauses, or tests.
"shall not confer a presumption"
Under the Radio Equipment Directive, presumption of conformity depends on harmonised standards, or parts of standards, whose references have been published in the Official Journal for the Article 3 requirements they cover.
This guide helps connect OJEU checks, Article 3 requirement mapping, radio and EMC test planning, notified-body route decisions, and Annex V technical documentation.
Structured answer sets in this page tree.
Cited legal and guidance references.
A RED standards and test-plan file must show which Article 3 requirement each standard covers, whether the exact reference is OJEU-cited, whether it is applied in full or in part, what test evidence covers the product configuration, and which conformity route addresses every gap. A cited harmonised standard gives only for the essential requirements and parts covered by its Official Journal reference, subject to any notice. Check the current consolidated Implementing Decision (EU) 2022/2191 and its amendments, not the 2022 legal act alone.
Build the matrix from the product configuration and the RED requirement, not from a supplier's old certificate. For each hardware, antenna, firmware, accessory, and intended-use variant, identify the applicable Article 3(1)(a) safety and health requirement, Article 3(1)(b) EMC requirement, Article 3(2) efficient spectrum-use requirement, and any activated Article 3(3) requirement.
Then map each requirement to the harmonised standard reference and version being used. is available only for harmonised standards or parts whose references have been published in the Official Journal, only for the essential requirements they cover, and subject to any notice attached to the citation. Implementing Decision (EU) 2022/2191 has been amended repeatedly, including on 9 December 2025, so an undated copy of the original annex is not a reliable release record.
The test plan should explain how the selected standards become release evidence. For every claimed standard, identify the sample, configuration, operating mode, antenna, firmware, accessories, laboratory report, acceptance criteria, and any standard clause or OJEU notice that affects the conclusion.
Where a cited standard is limited by a notice, applied only in part, scheduled for withdrawal, or not a clean match for the equipment, the plan needs a separate gap row. Name the missing characteristic, the date on which a citation change takes effect, and the evidence used instead, such as additional testing, design analysis, calculations, risk assessment, supplier data, or notified-body evidence.
For RED cybersecurity, Implementing Decision (EU) 2025/138 cites EN 18031-1:2024, EN 18031-2:2024, and EN 18031-3:2024 with restrictions. The notices exclude presumption for the standards' rationale and guidance sections and for specified password, parental-control, and secure-update cases. Record the applicable notice and the separate evidence used to close it.
For Article 3(2) and Article 3(3), route selection is part of standards planning. If the manufacturer has not applied OJEU-cited harmonised standards, has applied them only in part, or no such standards exist for those requirements, RED Article 17 points to EU-type examination followed by conformity to type, or to full quality assurance, for those essential requirements.
That decision should be made before release testing is treated as complete. The same uncited or partial standard may be acceptable technical evidence, but the file still needs to explain whether Article 17 requires notified-body involvement for the affected requirement.
RED Article 21 requires technical documentation to contain the relevant data or details of the means used to ensure compliance with Article 3, and says the documentation must be drawn up before the equipment is placed on the market and continuously updated. Annex V then names the standards list and alternative-solution description as part of that evidence set.
For a reviewer, the record should make the release decision reproducible. It should connect the standards matrix, test plan, reports, design evidence, supplier evidence, declarations, and route decisions to the exact product and software configuration placed on the market.
Use Sorena to map RED Article 3 requirements to OJEU-cited standards, test evidence, notified-body triggers, supplier inputs, and technical-file records before market placement.
Most RED standards errors come from overstating what a document proves. A test report, module certificate, draft standard, withdrawn standard, or supplier declaration may be useful, but it does not supersede the need to map the finished equipment to the applicable Article 3 requirements and OJEU-cited standards.
Claim presumption only for the OJEU-cited standards and parts that cover the requirement. Describe every other standard or test as supporting technical evidence.
"shall not confer a presumption"
"with restrictions"
"responsible for the conformity assessment"
"essential requirements set out in Article 3"
"Stay up to date"