Radio Equipment Directive 2014/53/EU
The main objective of the Directive is to establish a regulatory framework for the placing on the market, free movement and putting into service of radio equipment in the territory of the European Union.
The European Radio equipment and Telecommunications Terminal Equipment (R&TTE) Directive (1999/5/EC) was published in the Official Journal of the European Communities on the 7th April 1999. The Member States had until 20th January 2011 to adopt and publish the national laws and regulations transposing the provisions of the new Directive into national law.
The original Radio and Telecommunications Terminal Equipment Directive (R&TTE) 1999/5/EC was in place for over 15 years and served the radio and telecoms world well. However, with developing technology came the requirement to develop regulatory requirements and after review the new European Radio Equipment Directive (RED) 2014/53/EU was published in the Official Journal of the European Commission on May 22nd 2014 and which became mandatory on the 12th of June 2017.
Please contact us for the up to date requirements of the Radio Equipment Directive.
Requirements of the Directive
The essential requirements for radio equipment, which include constructing radio equipment to both effectively use and support the efficient use of radio spectrum in order to avoid harmful interference (article 3.2), are harmonized via the Radio Equipment Directive (RED), Directive 2014/53/EU, The RED regulates the requirements that products, within its scope, must meet in order to be placed on the market and put into service (without prejudice to conditions attached to authorizations for the use of radio spectrum or other applicable EU legislation). The most common way for manufacturers to comply with these requirements is to apply the voluntary Harmonised Standards developed by ETSI under the standardization request contained in the M/536 Commission Implementing Decision of the EC (if voluntary harmonised standards whose references are published in the OJEU are applied, they provide a presumption of conformity, therefore a manufacturer may apply other equivalent practices or specifications). The Directive is enforced at national level by Member States, in particular by Market Surveillance Authorities.
Protection of health and safety of the user and any other person, based on the protection requirements of the Low Voltage Directive (article 3.1a of the Directive) the essential requirements of the Electromagnetic Compatibility Directive (article 3.1b).
• Perform related R&TTE (RED) testing
• Compile a Technical File
• Prepare a Declaration of Conformity
• Put CE Marking on the product
The Directive applies to:
any “relevant apparatus”basically, if R&TTE (RED) performance can be meaningfully measured, then the directive applies.
Installations (i.e. an assembly of individual pieces of apparatus brought together on a specific site).
There are some addtional requirements listed in the Directive:
• Ships using inland waterways (EC Decision 2000/637/EC)
• Marine distress & safety equipment (EC Decision 2004/71/EC)
• Marine Identification System (EC Decision 2005/53/EC)
• COSPAS-SARSAT locator beacons (EC Decision 2005/631/EC)
• Avalanche beacons (EC Decision 2001/148/EC).
Please refer to the R&TTE (RED) Directive for detailed requirements.
Services that we offer as a Notified Body
Technical File Review:
A Technical File is required in order to comply with the R&TTE (RED) Directive. We will review your Technical File for conformity to the requirements of the directive and provide recommendations on any areas requiring further action or improvements.
Technical File Lodging:
CEM will acknowledge receipt and provide secure storage for 10 years after the date of last manufacture.
EMC and LVD Testing Service
CEM will arrange for equipment to be tested to ensure that it conforms to the requirements of the R&TTE (RED) Directive.
The technical documentation shall be drawn up, in accordance with Article 21 of the Directive, before the radio equipment is placed on the market and shall be continuously updated.
Manufacturers shall keep the technical documentation for 10 years after the radio equipment has been placed on the market.
Annex V describes the technical documentation. The technical documents must enable the assessment of the conformity of the product with the requirements of the Directive. The documentation must cover:
• a general description of the product including:
• photographs or illustrations showing external features, marking and internal layout
• versions of software or firmware affecting compliance with essential requirements
• user information and installation instructions
• a conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements
• descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product
• a list of the harmonised standards applied in full or in part, and where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of the Directive including a list of other relevant technical specifications applied
• a copy of the EU declaration of conformity
• where the conformity assessment module in Annex III has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved
• results of design calculations made, examinations carried out, etc.
• test reports
• an explanation of the compliance with the requirement of Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10).
The manufacturer or their authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
What about information for the user? See article 10.8 of the Directive, and its language regime which depends on national regimes. Any potential restrictions or requirements for authorisation of use of the radio equipment in certain Member States shall be marked in order to alert the user.
At the time of writing many standards which were harmonised under the old directive are not as yet listed as harmonised under the new radio equipment directive. If you need to use a standard which is not yet harmonised it is advisable to seek advice from a notified body as you will need the services of such to certify your product and therefore have sufficient evidence of compliance to the radio equipment directive.
CEM International are a Notified Body for the Radio Equipment Directive and can provide assistance with certification.