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The “New Approach” Directives for the CE marking have been designed by the European Union in order to cover all the essential requirements for products from various sectors.
We report here a few guidelines according to Directives of interest:
EMC Directive
Verify requirements
Directive 2014/30/EU on Electromagnetic Compatibility (EMC) specifies in detail the essential requirements the product has to meet in order for the manufacturer to affix the CE marking.
Directive 2014/30/EU is intended to ensure that equipment liable to generate or to be affected by electromagnetic disturbance can be used in the electromagnetic environment for which it has been designed, without causing disturbances to other equipment or being affected by them.
The essential requirements regarding electromagnetic compatibility for equipment are set out in Annex I of the Directive.
The EMC Directive covers apparatus sold as single functional units to end users and It does not cover equipment which is specifically intended to be incorporated into a fixed installation and is not otherwise commercially available.
Also these are excluded from the scope of the Directive: radio equipment and telecommunications terminal equipment (objective of the RED Directive), aeronautical products and radio equipment used by radio amateurs.
A Notified Body is required?
Under the EMC conformity assessment procedures, the manufacturer is obliged to perform an EMC assessment of the apparatus. The EMC Directive does not require the intervention of a Notified Body. However, the manufacturer or his authorised representative in the Community can present technical documentation to a Notified Body which will review it and assess whether the technical documentation properly demonstrates that the requirements of the Directive have been met. If this is the case, the Notified Body will issue a statement confirming it. This statement shall be part of the technical documentation.
Then the manufacturer draws up the Declaration of Conformity to declare on his sole responsibility conformity to the relevant Directive. The establishment of the DoC is a legal obligation.
The Declaration of Conformity must include:
a reference to the Directive;
an identification of the apparatus;
the manufacturer’s details such as name and address;
a dated reference of the specifications under which conformity is declared (e.g.: technical standards used);
the date of the declaration;
the identity and signature of the person empowered to bind the manufacturer or his authorised representative.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, the manufacturer should consult the NANDO database.
Compliance verification
The conformity assessment process for apparatus covered by this Directive consists of an internal production control procedure carried out by the manufacturer. This entails checking that the equipment meets the electromagnetic compatibility requirements set out in Annex I, or that the relevant European Harmonised Standards have been correctly applied.
The manufacturer draws up and signs the EC Declaration of Conformity.
Once the chosen conformity assessment process is complete, the manufacturer can affix the CE marking to the equipment. This must be done in accordance with the instructions set out in Annex V of the Directive.
Technical documentation
Annex II to the EMC Directive requires the manufacturer to establish the technical documentation, that must enable the assessment of the conformity of the appliance with the requirements of the Directive.
The technical documentation should comprise:
A general description of the apparatus;
Evidence of compliance with the harmonised standards, if any, applied in full or in part;
Where the manufacturer has not applied harmonised standards, or has applied them only in part, a description and explanation of the steps taken to meet the essential requirements of the Directive, including a description of the electromagnetic compatibility assessment set out in Annex II, point 1, results of design calculations made, examinations carried out, test reports, etc;
A statement from the notified body, when the procedure referred to in Annex III has been followed.
The manufacturer or his authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed on the market.
LVD Directive
Verify requirements
Directive 2014/35/EU on Low Voltage Devices specifies in detail the essential requirements the product must meet in order for the manufacturer to affix the CE marking.
Directive 2014/35/EU is intended to remove all obstacles to the sale of low voltage electrical equipment within the EU, while, at the same time, ensuring that they offer the highest possible level of safety.
“Low voltage devices” are defined as any equipment designed for use with a voltage rating between 50 and 1,000 V for alternating current and between 75 and 1,500 V for direct current. Annex II to the Directive contains a list of equipment not covered, including electrical components of lifts, electricity meters, plugs and socket outlets for domestic use.
The Directive 2014/35/EU specifies that equipment must not endanger the safety of people, animals or property “when properly installed and maintained and used in applications for which it was made”. The key safety objectives for equipment covered are listed in Annex I.
It is necessary to consult the Directive in order to ensure that the product complies with all the essential requirements.
Compliance verification
Conformity assessment for products covered by the Low Voltage Devices Directive takes the form of an internal production control procedure carried out by the manufacturer himself, without the involvement of a third party. The details of this procedure are set out in Annex IV to the Directive.
The manufacturer or his authorised representative (established in the EU) must draw up and sign the EC Declaration of Conformity.
Annex III.B of the Directive describes the content of the Declaration of Conformity as follows:
name and address of the manufacturer or his authorised representative established within the Union;
a description of the electrical equipment;
reference to the harmonised standards;
where appropriate, reference to the specifications regarding which conformity is declared (e.g.: technical standards used);
identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorised representative established within the Union;
the last two digits of the year in which the CE marking was affixed (for the first time).
The declaration of conformity must be drawn up in at least in one of the official languages of the Union.
In the event of a national authority challenging a manufacturer’s conformity assessment, a Notified Body can draw up a report in response, though this must be submitted by the manufacturer or the importer.
To find the Notified Bodies appointed by the Member States, the manufacturer should consult the NANDO database.
Manufacturers are required to work with the market surveillance authorities in each Country where the equipment is sold. The manufacturer must take all appropriate actions to eliminate risks posed by low voltage electrical equipment.
Technical documentation
After completion of the assessment, the assessment procedure must be documented as set out in Directive 2014/35/EU, Annex IV, Nr. 3.
The technical documents must enable the assessment of conformity of the appliance with the requirements of the Directive. It must, as far as it is relevant for such an assessment, cover the design, manufacture and operation of the electrical equipment.
The technical file should comprise:
a general description of the electrical equipment,
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment,
a list of the standards applied in full or in part, and descriptions of the solutions adopted to satisfy the safety aspects of this Directive where standards have not been applied,
results of design calculations made, examinations carried out, etc.,
test reports.
The manufacturer or his 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 is placed on the market.
RED Directive
Verify requirements
Directive 2014/53/EU on Radio Equipment specifies in detail the essential requirements the product must meet in order for the manufacturer to affix the CE marking.
It is defined “radio equipment” an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination.
The essential requirements entail ensuring the health and safety of users (as expected by the Directive 2014/35/EU LVD, but with no voltage limit applying), as well as protection requirements with respect to electromagnetic compatibility (as expected by the Directive 2014/30/EU EMC), and an efficient use of the spectrum so as to avoid harmful interference. Other essential requirements, such as the protection of personal privacy and data, access to emergency services and services for users with disabilities, may also apply if specific Commission decisions have been adopted.
A Notified Body is required?
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.
Depending on the type of apparatus and whether or not harmonised standards are used, the Directive foresees different possibilities of assessment procedures. When the manufacturer did not use Harmonised Standards, or when these do not exist, it must present its technical file to a Notified Body, which will review it.
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 Declaration of Conformity (legal obligation) to declare, on his sole responsibility, conformity of each individual product to the relevant Directive.
The 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.
To find the Notified Bodies appointed by the Member States, the manufacturer should consult the NANDO database.
Compliance verification
The RED Directive offers a number of conformity assessment procedures, for example:
Module B – EU-type examination – EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of the radio equipment and verifies and attests that the technical design of the radio equipment meets the essential requirements set out in Article 3 of Directive 2014/53/EU.
EU-type examination shall be carried out by assessment of the adequacy of the technical design of the radio equipment through examination of the technical documentation and supporting evidence, without examination of a specimen (design type).
Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EC Declaration of Conformity.
Technical documentation
The Annex V of RED Directive describes the content of Technical Documentation.
The technical documents must enable the assessment of the conformity of the product with the requirements of the Directive.
The manufacturer or their authorised representative established in the European Community 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.
About information for the user: see article 6.3 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.
Once the necessary steps have been successfully completed, the CE logo must be affixed to the product.
Affix CE marking
The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and to the accompanying document.
The CE marking shall consist of the initials “CE” taking the following form:
The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.
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.
However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the “CE” marking has to indicate conformity only with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.
NOTICE: For RED Directive, if a Notified Body is involved in the evaluation activity, its identification number must be also displayed.