CE Approval Guide for Manufacturers <21>
Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Ecodesign of energy related products
Equipment and protective systems intended for use potentially explosive atmospheres
Explosives for civil uses
In vitro diagnostic medical devices
Noise emission in the environment
Non-automatic weighing instruments
Personal protective equipment
If your product(s) fall(s) within the sector of Radio Equipment the Directive 2014/53/EU on Radio equipment applies.
- Directive 2014/53/EU on Radio Equipment
- For further information on Directive 2014/53/EU on Radio equipment, please visit the Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs webpage dedicated to this sector by following this link: http://ec.europa.eu/growth/sectors/electrical-engineering/red-directive_en
Directive 2014/53/EU on Radio Equipment specifies, in Article 3, the essential requirements the product must meet in order for the manufacturer to affix the CE marking.
Radio equipment encompasses all products that use the radio frequency spectrum (like mobile phones, gate openers or broadcast transmitters).
The essential requirements as laid out in Article 3 of the Directive 2014/53/EU entail that radio equipment shall be constructed so as to ensure:
- the protection of health and safety of persons and of domestic animals and the protection of property
- an adequate level of electromagnetic compatibility
- that it both effectively uses and supports the efficient use of radio spectrum so as to avoid harmful interference.
Other essential requirements of public interest (such as the protection of personal privacy and data, access to emergency services and services for users with disabilities) may also apply if specific Delegated Acts have been adopted.
Manufacturers shall ensure that radio equipment shall be so constructed that it can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum.
Need for notified body?
Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.
A notified body is involved depending on which conformity assessment procedure has been applied.
A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number shall follow the CE marking.
When the Notified Body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the EU Declaration of Conformity (EU DoC) to declare on his sole responsibility conformity of each individual product to the relevant Directive. The establishment of the EU DoC is a legal obligation.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.
The manufacturer shall perform a conformity assessment of the radio equipment with a view to meeting the essential requirements set out in Article 3.
Article 17 of the Directive prescribes the conformity assessment procedures which are applicable.
Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity. The EU Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. Manufacturers shall keep the EU declaration of conformity for 10 years after the radio equipment has been placed on the market.
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.
Affix CE marking
Once the necessary steps have been successfully completed, the CE marking must be affixed in accordance with Articles 19 and 20 of the Directive.
The CE marking shall consist of the initials 'CE' taking the following form:
When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.
If a Notified Body is involved in the production control phase, its identification number must be also displayed as provided for in Article 20 (3) of the Directive.
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