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.
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)
'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.
3. What is Due Diligence?
Any manufacturer or importer should:
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.
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:
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.
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.
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
2014/30/EU Electromagnetic compatibility (EMC)
2014/53/EU Radio Equipment (RED)
2011/65/EU Restriction of Hazardous Substances (RoHS2)
2012/19/EU Waste electrical and electronic equipment (WEEE)
Compliance is demonstrated by various harmonised standards as follows:
Directive Assessment standard
EMC SI 2016/1091 BS EN 61326 - 1:2013
RED SI 2017/1206 ETSI EN 300 200-1
RoHS SI 2012/3032 BS EN 50581:2012
WEEE SI 2018/102 BS EN 50419:2013
'Harmonised Standard' is a standard that:
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:
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
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:
Compliance is against 'Essential Requirements', not standards.
Restriction of Hazardous Substances Directive (RoHS2)
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.
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.
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.
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.
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 RED 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.