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CE marking and manufacturers' and/or importers' legal obligations

Any European manufacturer selling into the EU must comply with the CE Directives that are relevant to their products.

Products which are manufactured outside the EU must also comply with the relevant CE Directives.

It is the sole responsibility of the importer of products manufactured outside the EU to ensure that they have been correctly CE marked by the manufacturer and a Technical File produced.

If products are manufactured outside the EU and not CE marked then it is the sole responsibility of the Importer to ensure CE marking of the product and produce a Technical File of his own.

OVERVIEW

The sections below explain the basics of CE marking

  1. What is CE marking?
  2. What are EU Directives?
  3. What is Due Diligence?
  4. How is CE Marking enforced?
  5. Who enforces CE marking?
  6. Declaration of Conformity
  7. What is a Technical File?

1. What is CE Marking?

Designed to enable free trade around European Union (EU) member States (note: some non EU countries like Turkey have adopted CE marking procedures)

It places responsibility with the manufacturer or importer of goods or whoever places the equipment on the market in the EU.

It relates to EU Directives (European Law) designed to ensure safety on the market place.

Most products require only self-certification but this should be backed up with any relevant testing such as EMC.

Just putting a CE mark on a product is not evidence of compliance in itself it has to be backed up by the Technical File (see section 7)

2. What are EU Directives?

'New Approach' Directives (Community Law) set out the essential requirements (on safety for example), written in general terms, which must be met before products may be sold in the UK or anywhere else in the European Community.

  • The directives also explain how manufacturers are able to demonstrate conformity with the essential requirements.
  • The directives do not contain all the required technical requirements.
  • Products which meet the essential requirements are to display the CE mark.
  • European harmonised standards provide the detailed technical information enabling manufacturers to meet the essential requirements.

3. What is Due Diligence?

Any manufacturer or importer should:

  • Know what is required to sell products into EU
  • Declare that they have met the relevant requirements.
  • Demonstrate compliance with relevant applicable Directives.
  • Be properly prepared.
  • Be ready to defend themself in court.
  • Produce a technical file.
  • Be confident in their safety case.

4. How is CE Marking enforced?

Directives are agreed, adopted & accepted by the governments of the member states into national law.

The Directives are “transposed into UK Law” as statutory Instruments.

This gives the Directives the same status as other laws in this country.

5. Who enforces CE marking?

Local trading standards departments within their region.

The Office of Communications (Ofcom) that has responsibility where enforcement relates to the protection and management of the radio spectrum.

The enforcement authority can:

  • Challenge any product on the Market
  • Pull samples from the Market for examination
  • Request a manufacturer, importer or retailer to provide their Technical file
  • Enlist the assistance of 3rd Party Laboratories to test or check products
  • Respond to public complaint
  • Notify other member states
  • Instigate criminal proceedings resulting in potential:
    • Banning of a product from sale
    • Ordering a product recall
    • Payment of fines
    • Imprisonment of responsible persons

6. Declaration of Conformity (DoC)

A formal statement that the product complies with applicable Directives and Standards

It should be signed by responsible person within the organisation (e.g. company director)

It is not evidence of compliance in itself.

A DoC is a minimum legal requirement and should have:-

The name and address of the manufacturer or their authorised representative

A description of the equipment including type, model and any other information that clearly relates the equipment to the Declaration.

A reference to the directives and standards applied harmonised standards that have been applied and when harmonised standards have not been applied, references to International or National standard(s) with which conformity is declared.

If standards have not been applied, reference should be made to other specifications adopted or to the safety objectives that have been applied and satisfied.

Identification of the signatory which must be someone empowered to enter into commitments on behalf of the manufacturer (or their authorised representative).

A formal declaration statement - the last two digits of the year in which CE marking was affixed.

7. Technical File

A technical file is the documented evidence to show that the product properly complies with the requirements of the directives which apply to it.

The documentation must be such as to enable enforcement authorities to assess the conformity of the electrical equipment to the requirements of the Regulations.

It must cover the design, manufacture and operation of the equipment.

It can be the same document as your design file for the equipment.

It forms the basis of the safety case.

DIRECTIVES

There are 20+ Directives that require CE Marking and below are the ones that would most typically be applicable to electrical/electronic products.

Directive                 Title of Directive

2004/108/EC            Electromagnetic compatibility (EMC)

1999/5/EC                Radio Equipment and Telecommunications Terminal Equipment (R & TTE)

2011/65/EU              Restriction of Hazardous Substances (RoHS)

2002/96/EC              Waste electrical and electronic equipment (WEEE)

Compliance is demonstrated by various harmonised standards as follows:

Directive                   Assessment standard

EMC                         EN 61326-1                         

R & TTE                    EN 61011 & ETSI               

RoHS                        SI 2008 No. 37        

WEEE                       SI 2006 No. 3289

'Harmonised Standard' is a standard that:

  • Supports one or more Directives.
  • Has been produced by CEN or CENELEC.
  • Has been published in the Official Journal of the EC (OJ).
  • At least one national standards body has published it.
  • Provides a presumption of conformity with the EHSRs.

These standards, produced under a mandate from Member States through the Commission, provide the technical measures to meet the EHSRs.

Electro Magnetic Compatibility Directive (EMC)

This applies to geotechnical sensors which have outputs of voltage, mA, Ohms, and vibrating wire.

Whilst vibrating wire is technically passive once the sensor is attached to a readout then the EMC directive will apply and therefore it is deemed “good practice” to apply the EMC directive to it.

Typical instruments include:

  • In-place inclinometers
  • Load cells
  • Pressure cells
  • Piezometers
  • Extensometers
  • Crack meters
  • Strain gauges
  • Data loggers

All products should be designed and manufactured to ensure that:

The electromagnetic disturbance it generates does not exceed a level above which radio and telecommunications equipment or other equipment cannot operate as intended.

It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.

Low Voltage Directive (LV)

This applies to instruments and associated equipment with a Voltage rating of between 50-1000Vac and 75-1500 Vdc

Voltage ratings refer to the voltage of the electrical input or output, not to voltages which may appear inside the equipment.

Typical products include

  • Data loggers (without radio)
  • Surge arrestors

Products must:

  • Be marked with their rated characteristics.
  • Clearly marked with the brand name or the trade mark, where that is not possible, on the packaging.
  • Be made in such a way as to ensure that it can be safely and properly assembled and connected.
  • Protect against hazards arising from the electrical equipment:
  • Ensure that persons and domestic animals are adequately protected against the danger of physical injury or other harm which might be caused by direct or indirect contact.
  • that temperatures, arcs or radiation which would cause a danger, are not produced.
  • that the insulation must be suitable for foreseeable conditions.

Radio and Telecommunications Terminal Equipment Directive (R&TTE)

This applies to any instrument which uses any form of radio communication including Bluetooth.

Typical instruments are:

  • Portable inclinometers
  • Data loggers (with radio)
  • Wireless systems

Compliance is against 'Essential Requirements', not standards.

  • Health & Safety (as required by 2006/95/EC (LVD) (includes any RF exposure requirements)
  • EMC (as required by 2004/108/EC (EMC-D)
  • Radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference.

Restriction of Hazardous Substances  Directive (RoHS)

Applies to all electronic components used to manufacture sensors and readout equipment.

Restricts the use of Hazardous Substances – lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls or polybrominated diphenyl.

  • Applies to Electrical & Electronic Equipment 'EEE'.
  • Applies to complete products.
  • Involves the complete supply chain and should be able to demonstrate documented evidence of compliance from suppliers.

Waste electrical and electronic equipment Directive (WEEE)

All electrical equipment is required to be recycled unless it is permanently installed (non-retrievable) as is typical with geotechnical instruments. However it is the responsibility of the manufacturer or distributor to ensure that facilities exist to allow re-cycling of all unwanted products and if required is available for all products supplied by Geosense.

IMPORTANCE

Whilst most people think that CE marking is based around quality it is not. The main philosophy behind CE marking is one of SAFETY and COMPLIANCE. The majority of Geotechnical and structural instruments have electronic components and electrical signals including vibrating wire. More and more are now using radio and Bluetooth systems.

EMC

Products and systems which use electricity and/or electronics are said to be Electromagnetically Compatible when their emissions do not cause unacceptable interference with other electrical and/or electronic products and systems, and when they have sufficient immunity to operate as required in their electromagnetic environment.

The increase in electronic component density in equipment, on and around construction sites, particularly in urban areas, associated with an increase in clock frequencies and a more and more polluted electromagnetic environment, lead to a higher risk of equipment electrical failures.

If products have not been correctly designed and tested to prove compliance to the EMC Directive then they could cause serious implications on functional or personal safety.

One major source of EMC for instruments is their cables. These tend to run along routes on site together with other cables carrying power and other signals which often have 'dirty' signals e.g. generators. To ensure that instruments are not affected by this EMC it is vital that instruments use appropriate screened cable to avoid the EMC being transferred from the surroundings into the sensor and or data logger.

R & TTE

Radio waves are simply part of the electromagnetic spectrum and have different frequencies. Frequencies between about 3 kHz and 300GHz comprise the radio frequency (RF) band.

The R&TTE Directive applies to all equipment that uses the RF spectrum and all terminal equipment attached to public telecommunication networks (PSTN).

Such equipment includes transceivers, transmitters and modems.