Frequently Asked Questions

and

answers
for
successful
CE  marking

 

 

 

1 What is a “New Approach” directive?

 

The aim of the New Approach is twofold:

 

(a)       to ensure the free movement of industrial products within the internal market of the European Union;

(b)        to guarantee the safety of European consumers and users of these products.

 

The "New Approach" concept was developed by the European Commission in 1985 to accelerate the process of harmonisation of Member State legislation for a series of industrial products. The concept makes it possible firstly to limit intervention by European legislators in essential safety regulations, and secondly allows firms to choose the technical means of incorporating these in the manufacture of their products.

 

To do this, Community bodies adopt "directives", framework texts which each Member State can use as uniform common denominators for transposition into national laws. Contrary to the old directives, which required manufacturers to follow strict and precise technical enacting terms, new approach directives are based on two important ideas:

 

¶   the obligation to meet essential safety requirements that are identical throughout the European Union (EU) and the European Economic Area (EEA);

 

¶   cross reference to voluntarily applicable harmonized (EN) European standards for the technical specifications of a product.

2        what is CE marking?

 

CE marking is the visual symbol, printed on products placed on the market, signifying that the product meets the essential safety requirements of a “New Approach” directive. It is therefore a passport allowing free movement of the product throughout the territory of the European Union.

 

 

 

 

 

 

3        What is a harmonised (EN) European standard?

 

Within the framework of the "New Approach", a harmonized EN translates essential safety requirements outlined in directives into technical instructions. In some ways it is a technical specification which provides manufacturers with “how to” information. Although their application is voluntary, compliance with a harmonized European standard confers a presumption of conformity to the basic safety requirements laid down in the relevant directive. These European standards are only said to be harmonized once they have appeared in the Official Journal of the European Communities (OJEC).

 

 

 

4        can a product be covered by several “New Approach” directives?

 

YES. A single product may give rise to different risks. Example: a mains-powered electronically-controlled machine is covered by the “machine” directive in terms of mechanical hazards, by the “electromagnetic compatibility” directive in terms of the risk of electromagnetic disturbance it might cause or which might affect it, and by the “low voltage” directive in terms of its electrical hazards.

 

Another example - a mains-powered medical diagnostic device is covered:

 

·      by the “medical devices” directive in terms of the risks to which patients or medical personnel are exposed when it is in use,

·      the “electromagnetic compatibility” directive in terms of the electromagnetic disturbance it might cause or which might affect it.

 

However, for the “medical devices” directive, in this particular instance, this problem only arises during the interim period, ie until 14 June 1998, from which date only directive 93/42 (medical devices) will be compulsory.

 

 

 

 

5        Will a product covered by several directives have several CE markings?

 

NO. By means of a single CE marking the manufacturer or person responsible for first placing the product on the market certifies conformity to the essential safety requirements of the various directives which apply to the product concerned. However, the directives to which a product conforms must be specified and quoted on the declaration(s) of conformity by the manufacturer or his agent, who must also prepare supporting documentation for this marking (production documents, technical documents, etc) for each directive concerned.

 

 

6        How do I know if my product is covered by the “machines”, “PPE”, “electromagnetic compatibility”, “low voltage” or “medical devices” directives?

 

By referring to the texts of the directives or those of the national measures which transposed them Like all “New Approach” texts, these directives give a field of application identifying product groups that are covered and, where relevant, product groups that are excluded which may be covered by other specific directives. It is not possible here to list all fields of application for all of these directives, but only a few examples of products that are covered or excluded:

 

X Examples of products covered by the EMC:

Household electrical appliances, radio and television receivers, radio and broadcasting transmitters, lamps with a starter for fluorescent lighting, telecommunication equipment, electronically-controlled machines, etc.

 

XExamples of products excluded from the EMC:

Radio equipment used by amateur radio enthusiasts, except where equipment is available in the shops, motorised vehicles, etc.

 

X Examples of products covered by the LV:

Household electrical appliances, programmable logic controllers, measuring equipment, data processing equipment, electrical conductors, lamps, etc.

 

X Examples of products excluded from the LV:

Electrical equipment intended for use in an explosive atmosphere, electro radiology and medical electrical equipment, electrical components of lifts and elevators, electrical meters, power outlets (sockets and plugs) for household use, power-supply devices for electric fences, specialist electrical equipment intended for use on ships, planes or on railways.

 

X Examples of medical devices:

Products for the care of contact lenses, condoms, syringes, devices used in dentistry, breathing and anaesthesia equipment, thermometers, lasers, etc.

 

X Examples of medical devices excluded:

Devices for in vitro diagnosis, cosmetic products, human blood, blood by-products, plasma, organs, tissue or cells of human origin, organs, tissue or cells of animal origin (except for the use of tissue made non-viable), personal protective equipment (depending on its purpose), biocides.

 

X Examples of active implantable medical devices:

Pacemakers, neurostimulators and implantable pumps, also cochlear implants.

 

X Examples of machines:

Practically anything that is capable of movement for a particular purpose is concerned, in particular lifting equipment and mobile equipment, cardan shafts, robotised and automated workshops, circular saws and sawing machines, smoothing, planing, tenoning machines, presses, plastics and rubber moulding machines, cartridge-operated hammers, etc.

 

X Examples of machines excluded:

Machines for which the sole source of energy is directly-employed human strength (eg: pliers, scissors, etc), special funfair equipment, steam boilers and pressure vessels, firearms, sea-going vessels and mobile offshore units, agricultural and forestry tractors, machines falling into the category of household electrical (< 4KW), audiovisual equipment, etc.

 

X Examples of PPE:

Swimming and skiing goggles, most helmets, including sports helmets, clothing allowing intervention in exceptional or extreme atmospheric conditions, lifebuoys and life jackets worn continuously, breathing apparatus, etc.

 

X Examples excluded from PPE:

Helmets intended for use with 2-wheel or 3-wheel motor vehicles, spectacles, PPE designed and manufactured for the armed forces or police, equipment providing self-defence against assault (aerosol generators), equipment designed and manufactured for private use, such as washing-up gloves, boots or umbrellas, etc.

 

 

 

 

 

7        what are the national texts transposing these directives?

 

EMC (89/336/EEC,92/31/EEC):

·      The Electromagnetic Compatibility Regulations Of 05/10/92, Statutory Instruments No 2372 Of 1992

·      The Electromagnetic Compatibility (Amendment) Regulations Of 02/12/94, Statutory Instruments No 3080 Of 1994

LOW VOLTAGE(73/23/EEC):

·      Guidance To Electrical Equipment For Use At Work U.K. Hsr 18, Statutory Instruments No 1366 Of 12/08/75

·      Guidance To Electrical Equipment For Use At Work U.K. Hsr 18, Statutory Instruments No 1208 Of 30/07/76

·      Guidance To Electrical Equipment For Use At Work U.K. Hsr 18, Statutory Instruments No 137 Of 18/05/77

·      Electricity Supply Regulations 1977

·      The Low Voltage Electrical Equipment (Safety) Regulations 1989, Statutory Instruments No 728 Of 1989

·      The Electrical Equipment (Safety) Regulations 1994 Of 15/12/94, Statutory Instruments No 3260 Of 1994

MACHINES(89/392/EEC,91/368/EEC,93/44/EEC):

·      The Supply Of Machinery (Safety) Regulations 1992 Of 30/11/92, Statutory Instruments No 3073 of 1992

·      The Supply Of Machinery (Safety) Regulations 1994 Of 26/07/94, Statutory Instruments No 2063 Of 1994

PPE (89/686/EEC), 93/95/EEC):

·      The Personal Protective Equipment Regulations 1992 Of 10/12/92, Statutory Instruments No 3139 Of 10/12/92

·      The Personal Protective Equipment (EC Directive) (Amendment) Regulations Of 05/09/94, Statutory Instruments No 2326 Of 1994

ACTIVE IMPLANTABLE MEDICAL DEVICES(90/385/EEC):

·      Consumer Protection Regulations Of 10/12/92, Statutory Instruments No 1992/3146 Of 10/12/92

MEDICAL DEVICES(93/42EEC):

·      The Medical Devices Regulations Of 28/11/94, Statutory Instruments No3017 Of 1994

 

 

8        Despite everything I still don’t know if my product, which is slightly unusual, is covered by the regulations?

 

Most difficulties concerning the interpretation of texts raised by special cases have today been resolved. However, if this is not true in your own case, you can write to your Euro Info Centre or to the national authority responsible, who will be able to provide an interpretation corresponding to your equipment, or refer the matter to the European Commission.

 

9        What are the final dates for bringing my products into conformity with the applicable directive(s)?

 

“New Approach” directives all specify an interim period. This gives manufacturers time to bring their products progressively into conformity with essential Community safety requirements. Therefore, until the end of this period, manufacturers can continue to place on the market products which comply only with the national regulations in force in the country in which their products are sold, subject to the application of other directives.

 

The EMC directive came into force on 1 January 1992 with an interim period running until 31 December 1995. Since 1 January 1996, compliance with the directive has been compulsory for all EMC products.

 

The LV directive came into force on 26 September 1974. Compulsory CE marking for the products it covers was only introduced by a modifying text in 1993 (directive 93/68/CEE), making it a real New Approach directive. From 1 January 1997, all LV products must have CE marking.

 

The "Machines" directive has been applicable since 1 January 1995, following an interim period which lasted two years.

 

The "PPE" directive has been applicable since 1 July 1995, following an interim period which lasted three years.

 

Directive 93/42/CE "medical devices" came into force on 1 January 1995, with an interim period set to expire on 13 June 1998. From 14 June 1998, all medical devices must have CE marking in order to be distributed freely in the European Union.

 

Directive 90/385/CEE "active implantable medical devices" has been applicable since 1 January 1995. Since this date, active implantable medical devices are subject to compulsory CE marking in the European Union.

 

 

 

 

10      It would appear that even at the catalogue stage, products must be in conformity. Is this true?

 

Indeed it is, since the notion of first placing on the market is comparable to offering for sale. From that time, machines offered for sale in a catalogue must meet the requirements if they are intended for use in Europe. There is only one exception to this principle, and this is exhibitions, where the equipment on offer does not need to meet the requirements if a written information panel, legible by visitors, is provided.

 

 

11      Customers have asked me for CE marking during the interim period. Is this allowed?

 

Yes. From the time directives enter into force, even in the interim period, a customer may well prefer to purchase a product that already has CE marking. Either for safety reasons, or because he may prefer not to stock non-conforming products that would be difficult to move after the final date. This is a commercial matter between manufacturers and their customers, even if this request is often perceived by the manufacturer as legally unfounded or as a temporary or hidden hindrance.

 

Companies see the interim period in different ways: a commercial advantage or simply a period of time in which to bring products into conformity.

 

 

12      There seem to be several directives relating to machines and personal protective equipment. How do I identify which one(s) to apply?

 

An important distinction must be made between obligations affecting manufacturers or designers of machines (or those responsible for first placing the product on the European market, directive 89/392 amended) and those affecting users of machines (directive 89/655 amended). The same distinction is valid for PPE manufacturers (directive 89/686 amended) and PPE users (directive 89/656).

 

·      In the first case, the managers of companies which manufacture machines or PPE (or those responsible for first placing them on the European market) must ensure that their products meet the "essential safety requirements" indicated in the applicable directives and, once this is the case, provide them with CE marking to indicate that they are in conformity, on pain of no longer being able to sell their machines in the European Economic Area (E.E.A.) nor in the home market.

 

·      The second case concerns company managers who use machines or PPE (already placed on the European market) in their firms, so that they can be sure that they are not putting the workers who use them at risk. In addition, they are required where necessary to modify machines accordingly, in line with the instructions outlined in the corresponding directive.

 

Both cases concern machines and PPE, and compliance with European regulations; however the first case deals principally with new machines and PPE (unless they originate from a country outside the EEA), while the second covers machines and PPE that are in service.

 

 

 

13      What are my obligations with regard to the directive that applies to me?

 

You have to ensure that products meet the "essential safety requirements” of the directive which applies to them, and draw up and supply the supporting documents inherent in CE marking.

 

For EMC:

Electrical and/or electronic appliances must be designed:

X not to generate an excessive level of electromagnetic disturbance,

X to operate without interference from electromagnetic disturbance.

 

For LV:

Electrical appliances must provide safe and simple connections, be insulated and provide adequate protection, users must be correctly informed. Also, these appliances must take into account risks of non-electrical origin at the design stage.

 

For Machines:

The essential health and safety requirements which machines must meet fall into two categories:

 

1.   requirements common to all machines in terms of general product safety (eg: elimination or reduction of risks wherever possible, considering not only normal use of the machine but also possible abnormal situations, etc). These requirements concern controls and control circuits for shutting down the machine, mechanical risks, specified characteristics of guards and protective devices, maintenance operations, etc (eg: controls must be clearly visible and identifiable, located to ensure their safe use).

2.   additional requirements applicable to machines presenting special risks or in connection with particular operating constraints such as consideration for food hygiene, lifting, mobility, etc.

 

For PPE:

«PPE must provide, under conditions of use conforming to its intended purpose, adequate protection against the risks incurred.»

 

The essential safety requirements which PPE must meet fall into three categories:

 

1.   Common requirements applicable to all PPE concerning design methods, harmlessness, factors relating to comfort, efficiency, etc.

2.   Additional requirements common to several groups or types of PPE. For example PPE which contains adjustment systems, or which envelops the parts of the body to be protected, or which is subject to ageing, etc.

3.   Additional requirements specific to the risks to be prevented. For example, mechanical impact, physical assault, drowning, dangerous substances and infectious agents, etc.

 

For Medical Devices:

 

1.   General requirements:
devices must be designed so that their use does not compromise the safety and health of patients and users;

2.   Requirements concerning design and construction:
the manufacturer must ensure that the characteristics and performance of medical devices does not deteriorate during transportation and storage.

The main risks to be eliminated therefore concern:

 

·      specific properties of the product:
the toxicity of materials used in its construction, incompatibility with materials, substances or gases in contact with the device, etc.

·      risk of infection for the patient or user:
devices must be easy to handle, sterile products must meet very strict requirements, the packaging system must minimise all risk of bacterial contamination, etc.

·      risks related to the environment in which it is located:
magnetic fields, electrostatic discharges, interference, variations in temperature or pressure, etc.

·      risk of use contrary to the purpose of the device:
to overcome this risk the directives include numerous requirements concerning labelling and the drawing up of written instructions.

 

 

14      How should I proceed in concrete terms?

 

“New Approach” directives do not contain any precise technical specifications which provide the manufacturer with “how to” information enabling him to meet the essential safety requirements they outline.

They refer the reader to standards for this purpose, in particular to the harmonized (EN) European standards, which constitute the reference tool of the state of the art most widely used by professionals. Consequently, the harmonized European standards have two aims: to translate “essential safety requirements” into technical instructions, and to confer a presumption of conformity to the directive.

 

 

 

15      What if there is no standard for my product, or the existing standard is not adapted to my product?

 

This problem can arise in the case of customised products. The manufacturer can then establish his own frame of reference, a set of in-house technical specifications or “good manufacturing practices”. These must sometimes be validated (eg: EMC directive) through the intervention of a competent organisation.

 

 

 

16      So to fulfil my obligations and apply CE marking, I simply have to comply with the harmonised standards or another frame of reference?

 

Be careful not to confuse results with the means of achieving them. Under the terms of the directives, your products must meet essential health and safety requirements and you must certify this conformity, or arrange for certification to be provided. The application of standards, even harmonised standards, is never compulsory. However, compliance with them presumes that your products meet the essential safety requirements outlined in the directives.

 

Effective proof that you have fulfilled your obligations implies a procedure involving several steps:

 

1.   Determine the class or the category into which your product falls according to the directive (generally, directives classify products according to their degree of danger)

2.   Follow the module of proof of conformity (or “conformity evaluation procedure”) described in the directive for this class or category,

3.   Obtain and draw up documents which certify the conformity of your products (eg: declaration of conformity),

4.   Affix the CE mark.

 

For EMC two modules of proof of conformity are provided:

 

(a)       if the product is manufactured in accordance with an EN; the manufacturer may carry out his tests himself or call in an outside organisation which he is free to choose. ("self-evaluation"):

 

 (b)      if the product is not manufactured in accordance with an EN or if it is only partially manufactured in accordance with an EN, or if an EN does not exist for the product, the manufacturer submits technical documentation to a “competent” organisation which evaluates conformity and issues, once this has been attested, a certificate of conformity.

 

SPECIAL CASES:

 

1.   For appliances designed for radio communication transmissions, the manufacturer must call in a notified organisation which will evaluate conformity and, once this has been attested, issue a type certificate to the manufacturer.

2.   Case of Low Voltage product: the manufacturer must certify that his products meet the essential safety requirements outlined in the directive.

 

The conformity certification procedure laid down by the LV directive is still that of internal manufacturing controls (or “self-evaluation” by the manufacturer), enabling him to carry out his tests freely or to select the outside organization of his choice. However, in cases where the manufacturer does not comply with the standards, or only partially complies with them, it is recommended, but not compulsory, to go through a notified organization.

 

Note that in cases where the conformity of a product is questioned, or in the event of a dispute, the inspection authorities may request a report from a notified organisation.

 

Although they differ on a number of points, the procedures applicable to machines and to PPE are similar:

 

1.   Self-certification:

This is the procedure which, as a general rule, applies to machines.

For PPE it is rather the exception (class I PPE- see question 17).

This procedure requires the manufacturer himself to declare that his product meets the essential safety requirements affecting it. He may carry out his tests or verifications, or have them carried out, without the need to go through an outside organisation.

 

He draws up and signs the declaration of conformity, creates technical documentation and affixes the CE marking.

 

2. Type examination:

This is the procedure by which an approved organisation (one only, however it may be in another Member State of the European Economic Area) establishes and certifies that a model of machine or PPE complies with the technical regulations affecting it.

New machines subject to this procedure are listed in appendix IV of the directive (art.R 233-86 of the Employment Code).

 

For PPE, the type examination procedure concerns classes II and III (see question 17)

 

For machines (and not for PPE) there is a simplified type examination procedure, on completion of which the organisation issues an “acknowledgement of receipt” or a “certificate of adequacy”.

 

3. Additional procedures

These are compulsory and apply only to PPE which affords protection against the most serious risks (class III). They supplement the procedure and are two in number, namely the “quality guarantee system” and the “product quality assurance system with supervision”. The manufacturer can choose between these additional procedures.

 

Case of medical devices (directive 93/42):

Self-certification (or self-evaluation) by the manufacturer concerns only class I equipment. For other classes of products, recourse to a notified organisation is therefore compulsory. The manufacturer may however choose from among several modules of proof, often associated (example: type examination, product quality assurance, full quality assurance system with examination of design, etc.).

 

 

 

 

17      With regard to harmonised standards applying to medical devices, what is the relationship between the EN 29000 series of standards and the EN 46000 series of standards?

 

They are complementary.

EN 29000 standards are general standards concerning the requirements of quality systems.

EN 46000 standards define for manufacturers of all medical devices specific additional requirements to the general requirements outlined in EN 29000 standards.

 

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