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The technical documentation should let a reviewer connect the module evidence to the exact final radio equipment. Annex V requires a general product description, relevant photos or illustrations, marking and internal layout, software or firmware versions affecting compliance, user information, installation instructions, drawings, standards or other technical specifications, the EU declaration, and test or examination results where applicable.

When the host manufacturer reuses assessments performed for components or parts, the RED Guide says those assessments should be included in the technical documentation. The record should also explain why the host configuration stays inside the module supplier's conditions, or what added analysis or testing covers deviations.

Instructions matter because they define how the radio equipment is intended to be used. Article 10(8) requires instructions and safety information in a language easily understood by consumers and other end-users as determined by the Member State concerned. For intentional transmitters, the instructions also need frequency bands and maximum transmitted radio-frequency power information.

For accessories, components, and software that allow the radio equipment to operate as intended, the RED Guide focuses on items that influence conformity and are intended to be installed or changed by the user without the manufacturer's control. If the equipment is delivered without an antenna, the guide says the technical features of the antenna that may be used with the radio equipment should be provided to the user and mentioned in the DoC where needed.

Reopen the assessment when the product facts no longer match the evidence. A module test report or certificate is strongest when the host uses the same radio configuration, antenna conditions, software assumptions, installation limits, and intended environment that were assessed.

A change does not automatically mean the product fails, but it does need a documented review. The record should decide whether existing module and host evidence remains sufficient, whether additional testing or analysis is needed, whether a notified body route is triggered, and whether the DoC, instructions, labels, or technical documentation must be updated.

The RED does not treat SAR or RF exposure as a separate marketing claim. It is part of the Article 3(1)(a) health and safety essential requirement, assessed through the conformity assessment and documented in the technical documentation.

For a visitor-facing compliance record, answer the exposure question directly: identify the radio equipment, each intentional transmitter, frequency band, maximum RF power, antenna and enclosure configuration, operating modes, intended distance from the body, foreseeable near-body or next-to-ear use, and the standard or technical specification used to evaluate exposure.

Article 3(1)(a) is the obligation: radio equipment must protect health and safety. Article 17 is the assessment rule: the conformity assessment must cover intended operating conditions and, for Article 3(1)(a), reasonably foreseeable conditions. Article 10(8) supplies key transmitter facts for intentional emitters. Article 21 is where the supporting technical documentation is anchored.

That means the exposure answer should not be written only as a standards citation. It should be a traceable chain from product facts, to exposure scenario, to standard or technical specification, to test or analysis, to the declaration of conformity.

The exposure file should be reviewable without project history. A market-surveillance reviewer should be able to see what was assessed, what transmitter configuration was tested or analysed, which standard or specification was used, and why the conclusion still matches the product placed on the EU market.

For RED SAR and RF exposure, the strongest record is a compact evidence map: Article 3(1)(a) health and safety requirement, Article 17 use-condition assumptions, Article 10(8) frequency and power information, applicable harmonised standards, test reports, EU declaration, and change-control triggers.

Use the checklist to produce a documented yes, no, or needs-escalation answer for the specific radio equipment, not for a generic product category.

The main failure mode is mismatch: the evidence exists, but it does not match the product, antenna, firmware, accessory, frequency band, power setting, or use distance being sold in the EU.

Yes, but use it carefully. An uncited standard, a draft standard, a withdrawn standard, or a standard cited for a different scope can support the technical rationale, test plan, or design file. It should not be described as giving RED presumption of conformity unless the relevant reference, or relevant part of the reference, has been published in the Official Journal for the essential requirement you are claiming.

For RED, the practical consequence is route selection. Article 17 allows internal production control for some Article 3(1) assessments, but for Article 3(2) and Article 3(3), where OJEU-cited harmonised standards have not been applied, have only been applied in part, or do not exist, the equipment must be submitted to EU-type examination followed by conformity to type or to full quality assurance for those essential requirements.

Start with the requirement, not with the standard number. Identify whether the point is Article 3(1)(a) safety, Article 3(1)(b) EMC, Article 3(2) efficient spectrum use, or an activated Article 3(3) requirement. Then map each requirement to the OJEU-cited standard used, the parts applied, and any missing coverage.

Where the cited standard has a notice or restriction, treat the restriction as part of the record. A standard may be listed while still not conferring presumption for a particular clause, parameter, test condition, antenna configuration, receiver parameter, or other limited point. The technical file should explain how that excluded point is assessed.

For Article 3(2) and Article 3(3), Article 17 is explicit: if the manufacturer has not applied OJEU-cited harmonised standards, has applied them only in part, or no such standards exist, the equipment is submitted to either EU-type examination followed by conformity to type or full quality assurance for those essential requirements.

This does not mean every uncited standard automatically forces the same route. The route depends on which essential requirement the gap concerns and whether an OJEU-cited harmonised standard fully covers the relevant requirement for the exact equipment. The record should identify the gap before choosing the route.

The risky wording is usually not the use of the standard; it is the claim attached to it. A file can say that an uncited standard informed the test method or design rationale. It should not say that the product is presumed compliant under RED because of that standard unless the relevant OJEU citation supports that claim.

Supplier radio-module reports can be especially easy to overread. They may support part of the assessment, but the finished equipment file still needs to cover the actual host product, antenna configuration, software, intended use, instructions, and any Article 3 requirement not covered by the supplier evidence.

Start with Article 3(3)(d): it applies to any radio equipment that can communicate itself over the internet, whether directly or through another device. That trigger is about the equipment's own capability to exchange data with the internet, not merely whether the product is used near a network.

Then check Article 3(3)(e): it applies to covered equipment if it can process personal data under GDPR or traffic or location data under the ePrivacy Directive. The covered categories are internet-connected radio equipment, radio equipment designed or intended exclusively for childcare, radio equipment covered by the Toy Safety Directive, and wearable radio equipment.

Finally check Article 3(3)(f): it applies to internet-connected radio equipment if the holder or user can use it to transfer money, monetary value, or virtual currency. The application date for these 2022/30 requirements is 1 August 2025.

The first fact is whether the item is radio equipment under RED and can communicate itself over the internet. Delegated Regulation (EU) 2022/30 treats direct and indirect internet communication as relevant, so a device that reaches the internet through a phone, hub, gateway, or other intermediate equipment can still be internet-connected for this assessment.

The second fact is whether the equipment falls into a data-sensitive category. Article 3(3)(e) is not limited to ordinary internet-connected equipment; it also covers radio equipment designed or intended exclusively for childcare, radio equipment covered by the Toy Safety Directive, and wearable radio equipment when the data-processing trigger is met.

The third fact is payment capability. If internet-connected radio equipment enables the holder or user to transfer money, monetary value, or virtual currency, map Article 3(3)(f) separately from the network-protection and privacy/data-protection checks.

Use a short applicability record before choosing standards, tests, or notified-body routes. The record should answer which Article 3(3) point applies and why, rather than saying only that the product is connected or cyber-relevant.

The biggest error is compressing all RED cybersecurity into a single yes/no label. The delegated act applies different Article 3(3) points to different equipment categories, so the record needs to show which point applies and which product fact triggered it.

A product is radio equipment under Directive 2014/53/EU if it is an electrical or electronic product that intentionally emits and/or receives radio waves for radio communication or radiodetermination. The definition also covers an electrical or electronic product that must be completed with an accessory, such as an antenna, so it can intentionally emit or receive radio waves for those purposes.

That means the RED scope question is not limited to two-way radios. A receiver-only product can be in scope if its intended function is radio communication or radiodetermination, and a transmitter or transceiver is in scope when it intentionally uses radio waves for those purposes. The Commission RED Guide identifies pure television and sound broadcasting receivers as products that remained within RED scope when RED replaced the older R&TTE framework.

A product is not brought into RED scope merely because it involves electromagnetic phenomena. The Commission RED Guide says products that use electromagnetic waves exclusively for purposes other than radio communication or radiodetermination are not covered by RED, and gives pure wireless power transfer without communication or radiodetermination as an example.

RED also has explicit exclusions. Annex I excludes certain radio amateur equipment that is not made available on the market, marine equipment within the listed marine-equipment regime, airborne products, parts and appliances within the listed aviation regime, and custom-built evaluation kits destined for professionals for use solely at research and development facilities.

The technical file should show why the product was treated as RED radio equipment or why it was excluded. Keep the scope decision close to the product description, intended use, radio technology, frequency information, accessory and software dependencies, and any exclusion analysis.

Once the product is in scope, Article 3 evidence should be organized around the applicable essential requirements. Annex V technical documentation includes a general description of the radio equipment, relevant software or firmware versions, user information and installation instructions, design and circuit information, standards or other technical specifications used, EU declaration, notified-body certificate where applicable, design calculations and examinations, test reports, and the Article 10(2) and 10(10) explanations where relevant.

The main mistake is asking whether the product is a familiar radio category instead of applying the Article 2 definition. RED scope turns on the intentional emission or reception of radio waves for radio communication or radiodetermination, not on marketing labels such as smart device, sensor, accessory, module, or consumer electronics.

A second mistake is stopping after the scope answer. If the receiver or transmitter is in scope, the compliance file still needs the Article 3 requirements, applicable standards or other specifications, conformity assessment route, user information, EU declaration, CE marking, and technical documentation that match the exact radio equipment type.