As the regulatory landscape for radio equipment in the European Union evolves, manufacturers must comply with Directive 2014/53/EU. A key part of this compliance is preparing technical documentation to prove the product meets essential requirements.
Annex V outlines the key elements manufacturers must include:
General Description of the Equipment
This includes images or diagrams of the equipment’s external features, internal layout, software or firmware versions, and installation instructions.
Design and Schematics
Detailed drawings, circuit diagrams, and descriptions that explain the design and operation of the equipment must be provided.
List of Standards
A list of harmonized standards applied to meet the essential requirements should be included. If not fully applied, alternative solutions must be explained.
EU Declaration of Conformity
A copy of the EU Declaration of Conformity, certifying adherence to all relevant regulations, must be part of the documentation. You can request a draft of the Declaration of Conformity by contacting us.
Test Results and Calculations
Evidence of compliance should include test reports and analyses supporting the equipment’s conformity with technical and safety standards.
Notified Body Documentation (if applicable)
If a Notified Body was involved, their certification and supporting documents should be included.
Packaging Information
Details on marking, labeling, and packaging of the product must also be part of the file.
This documentation must be prepared before market entry and kept for at least 10 years to ensure regulatory compliance during potential checks.
How IoT Consulting Partners Group Can Help
At IoT Consulting Partners Group, we guide manufacturers through EU compliance processes, ensuring all required elements from Annex V are included and meet the highest standards. We help you navigate harmonized standards and manage the technical documentation process efficiently.
Contact us today to request a draft of the Declaration of Conformity or for expert assistance in ensuring your products meet EU requirements.
