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European Union published EU Directives as regulatory compliance requirements across EU Countries. An EU Directive is not in itself a law, but is a Directive to the governments of EU members to prepare laws implementing the Directive.



Products must be CE-Marked in Compliance with applicable EU Directive(s).




SIEMIC provides the following services to CE Compliance with:

Product Safety (Low Voltage Directive 73/23/EEC)
Electromagnetic Compatibility (EMC Directive 89/336/EEC, amended by 92/31/EEC, 93/97/EEC and 93/68/EEC)
Radio and Telecom Terminal Equipment (R&TTE Directive 95/5/EEC)
Routes to CE Compliance
CE Marking
Maintaining Compliance


PRODUCT SAFETY

The EU Product Safety Regulation was enforced on Oct 3rd, 1994. These regulations implement a European Council Directive (92/59/EEC) which was made in 1992. The regulations require:

- that any product supplied to a consumer in the course of a commercial activity, must be safe.
- a supplier should provide consumers with relevant information regarding the risks inherent in any product, where such risks are not immediately obvious without adequate warnings.
- a supplier should take steps to be aware of the risks associated with the use of supplied products

'product' means any product intended for consumers, or likely to be used by consumers, supplied whether for consideration (i.e. payment) or not and in the course of a commercial activity. It applies whether the product is new, used or reconditioned.

'safe' means any product which under normal or foreseeable conditions of use, including duration, does not present any risk or only the minimum risks compatible with the product's use, considered as acceptable and consistent with a high level of protection for the safety and health of persons, taking into account in particular:

(a) the characteristics of the product, including its composition, packaging, instructions for assembly and maintenance;
(b) the effect on other products, where it is reasonably foreseeable that it will be used with other products;
(c) the presentation of the product, the labeling, any instructions for its use and disposal and any other indication or information provided by the producer; and
(d) the categories of consumers at serious risk when using the product, in particular children, and the fact that higher levels of safety may be obtained or other products presenting a lesser degree of risk may be available shall not of itself cause the product to be considered other than a safe product.

The Low Voltage Directive (LVD) 73/23/EEC is one a series of measures introduced under article 100a of the Treaty of Rome. The effect of the directive has been to introduce identical requirements for the safety of electrical products in every country within the European Economic Area (EEA).

EMC

For the majority of electrical and electronic products, EMC requirements in the European Union are covered by the EMC Directive, 89/336/EEC, amended by 92/31/EEC, 93/97/EEC and 93/68/EEC.

Certain product types have EMC requirements which are covered by other EU Directives. These are:

Motor vehicles - covered by the Automotive EMC Directive, 95/54/EEC
Active implantable medical devices - covered by the Active Implantable Medical Device Directive, 90/385/EEC.
Medical devices - covered by the Medical Devices Directive, 93/42/EEC
In vitro diagnostic medical devices - covered by the In-vitro Diagnostic Medical Devices Directive, 98/79/EEC
Marine equipment, covered by the Marine Equipment Directive, 96/98/EEC
Equipment for use in aircraft in flight, covered by Council Regulation No 3922/91.

The EMC Directive covers electrical appliances, systems and installations. The Directive covers both emissions and immunity. However, products covered by other directives noted above have EMC requirements which are covered by the provisions in those specific directives.

The subject of the scope of the EMC Directive with relation to:

• components
• finished products
• systems
• installations

Products considered electromagnetically passive are excluded from the scope of the directive. Examples are:

• cable and cabling systems
• equipment containing only resistive loads without any automatic switching device
• batteries and accumulators

Certain other equipment is also considered exempt, for example:

• fuses
• circuit breakers without electronic parts, or other parts which are electromagnetically active
• manual switches, without parts which are electromagnetically active
• filament lamps
• quartz wrist watches, without additional functions

In addition, radio equipment used by radio amateurs is specifically excluded, unless the equipment is commercially available.


RADIO AND TELECOM TERMINAL EQUIPMENT

Radio and Telecom Terminal Equipment is regulated under R&TTE Directive 99/5/EC. Manufacturers, suppliers and importers of such equipment must apply one of the conformity assessment procedures of the Directive before CE marking the equipment and placing it on the market of the European Economic Area (EEA).

This Directive entered into force on 8 April 2000. After this date no new approvals under previous national or European laws could be issued. There was a transition period from 8th April 2000 to 7th April 2001 under which apparatus approved under previous national or European legislation could continue to be be supplied. However, from 8th April 2001 all apparatus within the scope of this Directive must comply with its provisions before being placed on the EEA market.

The scope of the R&TTE Directive relates to the equipment and components which fit within the definitions of radio equipment and telecommunications terminal equipment given in the directive.

The directive also applies to radio equipment and telecommunications terminal equipment, which is intended to be used within the scope of other Directives, eg, Medical Devices Directive 93/42/EEC without prejudice to Directive 93/42/EEC; Medical Devices Directive 90/385/EEC without prejudice to Directive 90/385/EEC; Vehicle Directive 72/245/EEC without prejudice to Directive 72/245/EEC; and Vehicle Directive 92/61/EEC without prejudice to Directive 92/61/EEC.

The R&TTE Directive does not apply to:

1. Radio equipment used by radio amateurs unless the equipment is available commercially. Kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment.
2. Marine equipment falling within the scope of Council Directive 96/98/EC.
3. Cable and wiring.
4. Receive only radio equipment intended solely for the reception of sound and TV broadcasting services.
5. Civil aviation products, appliances and components.
6. Air traffic management equipment and systems.
7. Apparatus exclusively used for activities concerning public security, defence, State security (including the economic well-being of the State in the case of activities pertaining to State security matters) and the activities of the State in the area of criminal law.

ROUTES TO CE COMPLIANCE

The Standards Route

Products are assumed to comply with the requirements of the EU Directive(s), if they can be shown to comply with the appropriate Harmonized Standard, as published in the Official Journal of the European Union. If there is a product specific harmonized standard, then this standard must be used, otherwise the appropriate generic harmonized standard can be used.

The manufacturer must build a technical file showing how the product complies with the appropriate Harmonized Standard. Most frequently, this will include a test report from a third party test house. Nevertheless, compliance may be justified on the basis of the manufacturer's own measurements, or even based purely on engineering arguments, without any test results. It is clear, though that the manufacturer's own data or engineering arguments would come under much greater scrutiny than a third party test report, in the case where the European authorities have reason to examine a manufacturer's claim to compliance.

The Technical Construction File (TCF) Route

The manufacturer may choose to build a Technical Construction File and present it to a Competent Body for assessment. If the competent body agrees that the TCF proves compliance with the Directive, it will issue a certificate certifying this. Reasons for using the TCF route include:

- There are no Harmonized Standards for the product
- Full Testing to the Harmonized Standard in impractical due to the size or location of the product
- A product range of many similar products, where testing each version would not be economical

EC Type Examination Certification

This is particularly applicable to the RTTE Directive which sets out a regulatory framework for radio and telecommunications terminal equipment in the European Union. Such apparatus must comply with certain essential requirements.

There are no references to specific technical standards in the Directive itself. Instead, reference is made to essential requirements that are generic. All apparatus must meet health & safety and EMC requirements. These requirements are cross-referenced to directives dealing specifically with such matters (Directives 73/23/EEC and 89/336/EEC respectively).

In addition, radio equipment is required to use spectrum efficiently and to avoid harmful interference.
Exceptionally, additional essential requirements, usually referred to as "Article 3.3" requirements, that relate to interworking, network harm, privacy, avoidance of fraud, access to emergency services and/or users with a disability may be imposed.

Since there are no references to specific standards, manufacturers have choice and responsibility in which technical standards to apply. Where the relevant parts of harmonized standards are used, then compliance with the essential requirements can be safely assumed.

The absence of harmonized standards does not mean that compliance with essential requirements cannot be demonstrated. Manufacturers may use any appropriate standards but there is not the guaranteed presumption of conformity that comes with the use of harmonized standards. For that reason, manufacturers may choose to or be obliged to involve a notified body (or other third party) in the assessment of conformity.

The Notified Body will issue an EC type examination certificate based on the evaluation.

CE Marking

By CE Marking the product and/or the packaging, the manufacturer declares that the product complies with all applicable EU Directives. For some products, the EMC Directive may be the only applicable directive, but for the majority of electrical and electronic products, other directives, usually related to safety, will be applicable, e.g. the Low Voltage Directive, the Machinery Directive, the RTTE Directive, etc.
In addition to the CE Marking, the manufacturer must prepare and sign a Declaration of Conformity. A copy of the DoC must be included with each item of the product shipped. Many manufacturers include the DoC in the User Manual. It is also recommended to include a copy of the DoC in shipping documents.

Maintaining Conformity

The manufacturer should take steps to ensure that his production remains compliant with the Directive. These steps may include:

• Basic quality procedures that ensure consistent production of the product
• Review of the effect on compliance of changes in design or of the applicable standards
• Periodic retesting (at least on a comparison basis)
• These measures must be documented, so that the manufacturer can prove to the authorities, if requested, that steps are taken to ensure continued compliance.

SIEMIC provides compliance testing, certification and consultancy on CE Compliance. To get an Estimate from SIEMIC, download SIEMIC International Approvals Questionnaires Form, complete the form with a list of products.