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CE Conformity Protocol

Structured and Traceable CE Conformity Documentation

Directive 2014/53/EU — Radio Equipment (RED)

5 minutes

Directive 2014/53/EU — Radio Equipment (RED)
Immeuble de bureaux

Structured Assessment Logic (SAL) – Your Roadmap for Compliance

SAL Type VI – Extended Public Interest Framework – NLF-based Multi-interest (multi-protected-interest) Framework

Mapping of RED 2014/53/EU


To implement the requirements of RED 2014/53/EU in a transparent and structured way, the regulatory assessment process can be represented using a Structured Assessment Logic (SAL). This logic ensures that all technical and regulatory requirements are systematically evaluated and that compliance is supported by documented evidence.


The SAL comprises the following steps:


  1. Product qualification – Is the product actually within the scope of the RED?

  2. Identification of relevant Article 3 requirements – Protection of health and safety following risk assessment, electromagnetic compatibility, efficient use of the radio spectrum, protection of other public interests.

    The risk assessment related to health & safety is required not only to evaluate and mitigate hazards, but also to identify which of the Annex I safety objectives are relevant to the specific equipment, based on its design, intended use, and reasonably foreseeable conditions of use.

  3. Assessment of harmonised standards and, where necessary, other means of fulfilment where such standards are not applied or do not exist – Which standards cover the requirements, and where are there gaps?

  4. Selection of the conformity assessment procedure – Self-assessment, EU Type-Examination, or Full Quality Assurance.

  5. Review of national restrictions – Are additional authorisations or limitations applicable?

  6. Technical documentation – Which records demonstrate compliance?

  7. Information and marking obligations

  8. Series Production – How is ongoing conformity ensured?

    Conformity is not limited to design and initial assessment; it must also be maintained throughout ongoing production. In practice, this means identifying and controlling those product and process characteristics whose deviation could compromise compliance with the relevant Article 3 requirements.

  9. EU Declaration of Conformity & CE marking – Official confirmation of compliance, ready for the EU market.


Note: SAL is not an end in itself. It provides a repeatable methodology that translates regulatory principles into a clear, structured assessment logic.


This diagram illustrates the SAL workflow visually:


Product definition

↓

Article 3 requirements

↓

Harmonised standards / other means of fulfilment

↓

Conformity assessment procedure

↓

National requirements

↓

Technical documentation

↓

Information and marking obligations

↓

Series Production

↓

CE marking & Declaration of Conformity


Interfaces to Related Legislation


When applying RED 2014/53/EU, there are often intersections with other regulatory frameworks that must be considered simultaneously:

  • Electrical safety legislation

  • Electromagnetic compatibility (EMC) legislation

  • Sector-specific regulations for connected products


A coordinated assessment is therefore necessary to avoid regulatory gaps or duplicated evaluations. In practice, this means SAL provides the roadmap, but it must always be applied in the context of related legislation.


Overview: Directive 2014/53/EU


  • Number: 2014/53/EU

  • Title: Directive on the making available on the market of radio equipment

  • Publication: OJ L 153, 22.5.2014, p. 62

  • Purpose: Establishes a framework for placing radio equipment on the market and putting it into service within the EU

  • Public interest: Product safety, electromagnetic compatibility, interference-free use of the radio spectrum, and other public interests related to radio equipment

  • Guidance: Guidelines on RED 2014/53/EU: Guide to the Radio Equipment Directive 2014/53/EU


Scope


RED applies to electrical or electronic devices that intentionally emit or receive radio waves. Typical products include:

  • Connected consumer devices & IoT equipment

  • Mobile communication devices

  • Wireless monitoring or control systems

  • Navigation or positioning technologies

Excluded categories include:

  • Amateur radio kits not commercially available

  • Certain maritime or aviation equipment

  • Research laboratory equipment

  • Equipment intended solely for public safety or defense

For “combined products,” see the Supplementary Guidance on the LVD/EMCD/RED.


Identification of applicable Core Requirements under Article 3


  1. Protection of health & safety
    • Persons, animals, property

    • Electrical safety, no voltage limits


  2. Electromagnetic Compatibility (EMC)
    • No interference with other devices

    • Immunity / resistance to external interference


  3. Efficient use of the radio spectrum
    • Avoidance of harmful interference


  4. Protection of other public interests
    • Network operation, data protection, fraud prevention, charging standards, and other requirements under Art. 3(3)


Harmonised Standards



Conformity Assessment Procedures


Manufacturers must select the appropriate procedure according to Article 17 and Annexes II–IV.


Available procedures:
  1. Internal Production Control (self-assessment)

  2. EU Type-Examination + Conformity to Type

  3. Full Quality Assurance


  • Health & Safety / EMC: Notified Body optional

  • Spectrum / Public Interest: Notified Body required if standards are not fully applied


National Restrictions


  • Indications on packaging and user instructions

  • According to Implementing Regulation (EU) 2017/1354


Information and Marking Obligations


  • Identification and manufacturer marking

  • User manual and safety information


Subject to delegated acts, manufacturers may also be required to provide information on the conformity of combinations of radio equipment and software and to register certain categories of radio equipment.


Series Production


The requirement for ongoing conformity is implemented in practice by ensuring that manufacturers identify and keep under control those product and process characteristics whose deviation could jeopardize compliance with the legal requirements.

This requires a systematic management of safety- and compliance-critical characteristics, defining how these characteristics are identified, monitored, controlled, and protected against unintended change.

 

CE Marking


  • Mandatory before placing the product on the EU market

  • Must be visible, legible, and permanent

  • Notified Body number required if involved


Conclusion


With SAL, the mapping as a roadmap, and consideration of interfaces to related legislation, it becomes clear how RED 2014/53/EU is systematically applied. The final workflow logically follows from scope through requirements, standards, and assessment procedures to CE marking – providing a clear orientation for manufacturers, assessors, and all stakeholders seeking regulatory clarity.

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© 2026 by Dr. Matthias K Bauer

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