Understanding the role of economic operators for Radio Equipment CE Marking Certification

When placing a product on to the market for sale in the European Union, manufacturers, importers and distributors all have a duty to fulfill specific responsibilities in order to demonstrate compliance to the relevant directives and achieve CE Marking.

Radio certification is no longer just the responsibility of the manufacturer

Use of the radio spectrum is highly regulated in European Union member states. The Radio Equipment Directive 2014/53/EU (RED) established a regulatory framework for placing radio equipment on the market. In the UK, it has been implemented into law since December 26, 2017 through the Radio Equipment Regulations 2017. 

Manufacturers, importers and distributors who do not comply with CE Marking regulations face punitive measures, including fines and prison sentences.

A 2019 meeting of the RED Administrative Co-operation Working Group (AdCo) provided further information regarding the obligations for each member of the supply chain, making it clear that radio certification is no longer just the responsibility of the manufacturer.  

The role of economic operators for CE Marking

Each ‘economic operator’ – the manufacturer, the authorized representative, the importer and the distributor – has their own obligations which they must fulfill. It is therefore extremely important to understand where you sit in the supply chain to ensure you are fulfilling these responsibilities. 

The manufacturer

The manufacturer of a product is responsible for ensuring product compliance and placing the CE mark on the product. This includes responsibility for undertaking a full risk analysis, complying with essential requirements, and being able to provide evidence of having done so. The manufacturer has a duty to apply the relevant harmonized standard to the product and determine if the standard is fully adequate for the product and its environment, or if the product requires further safety testing before being placed on the open market.

When a manufacturer CE marks a piece of equipment containing a pre-fabricated radio module, the manufacture of the complete equipment is responsible for the entire product. It is always the sole responsibility of the manufacturer to make sure that the end equipment is CE marked correctly. This includes all of the surrounding circuitry, including the radio module meets the requirements.

The importer

The importer must make sure that only products complying with legislation and bearing the CE mark are placed on the market and has a duty to check that the manufacturer outside the EU has performed the necessary steps. The importer needs to have an overall knowledge of the respective Union harmonization acts and have written assurance from the manufacturer that they will have access to the necessary documentation – such as the EU Declaration of Conformity and the technical documentation – to provide, if necessary, to the national authorities. 

The distributor

The distributor has a duty to ensure that only compliant products are made available on the market and have confirmation from the manufacturer or the importer that the necessary measures have been taken to be able to demonstrate that they have acted with due care.

Manufacturers can consider compliance early in the design process

In 2019, the RED Administrative Co-operation Working Group (AdCo) reported that during random testing, one in every three radio products on the market failed CE Marking due to technical issues, with the majority of these relating to RED non-compliance regarding the radio parameters. 

To prevent a product failing compliance and avoiding expensive redesign work, manufacturers must consider compliance early in the design process. Ideally, it is considered at the very start of a project. Products should be reassessed during the various stages of the design process to prevent problems being discovered late in the day, which could potentially delay the product getting to market or result in an expensive product recall. 

Element can support you throughout the entire radio compliance testing process. From generating bespoke test plans and performing pre-compliance investigations through to full formal conformance testing, we ensure you have all the regulatory and contractual compliance evidence required of you. To learn more about radio approval testing your device, please contact Element’s Engaged Experts.