Meaning
Technical compliance under the radio equipment directive establishes a legal requirement for conformity assessment through a designated body. Manufacturers subject module b to an EU type examination to verify that a product design meets the protection requirements defined in harmonized standards. This process results in an EU type examination certificate which the manufacturer keeps to support the declaration of conformity for the final product.
Verification Protocol
Assessment begins with the submission of technical documentation describing the design, manufacture and operation of the radio device to a notified body. Examiners review the technical files to ensure the radio equipment provides an adequate level of electromagnetic compatibility and efficient use of the spectrum. Experts perform these assessments without physical testing of every variation if the documentation sufficiently demonstrates the radio frequency performance.
Certification Scope
Validation remains restricted to the specific design type presented by the manufacturer rather than covering every individual item produced in a series. Any modifications to the hardware or internal firmware that deviate from the evaluated technical documentation require a new assessment. Product lines undergo this scrutiny to prove that the architecture remains compliant before the entity places the device on the market.
Compliance Burden
Administrative responsibility rests with the manufacturer who must retain all technical records for ten years after the equipment enters the market. Documentation storage ensures that authorities can audit the design validation process during a market surveillance check. Compliance with the directive functions as a prerequisite for affixing the CE mark to the equipment.