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The CE mark is a symbol that a manufacturer (see definition below) affixes to a product so that it can be sold in Europe. The mark is mandatory for products which fall under one of 24 European directives. The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance and environmental requirements. CE stands for “Conformité Européenne", the French for European conformity.

The mark is required in all 27 member states of the EU, as well as Iceland, Norway, and Liechtenstein. Switzerland accepts the CE mark for some products and Turkey actually requires that many products be CE marked.

The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under its own name.

The Canadian Standards Association (CSA) or the Underwriters’ Laboratories (UL) marks, for example, can only be used when those organizations have determined that a product meets applicable standards. European organizations do not grant authorization to use the CE mark as it is not owned by any particular body. The manufacturer is responsible for its proper use.

The manufacturer, whether established inside or outside the EU, is ultimately responsible for affixing the CE mark and is also responsible for its proper use. The manufacturer established outside the EU may appoint an authorized representative established in the EU to act on his behalf. CE marking is about more than affixing a symbol to a product.

How do you know if your product requires a CE mark? The first step is to see if your product is covered under one or more of the 24 CE directives below. If your product falls under any of these directives, it needs to be CE marked.24 CE directivesDirective NumberProduct Category2006/95/ECLow Voltage

For example, the EU directive for products which fall under theThe EMC directive first limits electromagnetic emissions of equipment in order to ensure that, when used as intended, such equipment does not disturb radio and telecommunication as well as other equipment. The directive also governs the immunity of such equipment to interference and seeks to ensure that this equipment is not disturbed by radio emissions when used as intended.- European Commission

Determining whether your product falls under one or more directives can be difficult. For example, if you manufacture electronic packaging machines with a conveyer belt, several directives will impact you. If you want to know which directives apply, you will have to go through each of the 24 directives (product coverage is sometimes found in an annex). There is no reference tool or database that lists which directives might be applicable to certain products. A trade commissioner can help you navigate these complexities.

Once you have figured out if your product falls under one or more directives, it’s time to assess if your product conforms to the applicable directive(s) and, if not, how you will achieve conformity.

The European Commission often provides mandates to European organizations (CEN, CENELEC and ETSI) to develop standards which are harmonized with the essential requirements of the directives.

In many cases, manufacturers may rely on standards other than harmonized standards in order to demonstrate compliance with the essential requirements in the directives. One notable exception to this rule is the Construction Products Regulation which makes the use of harmonized standards mandatory.

The European Commission often provides detailed guidelines on the application of specific directives, including details on the interpretation of the essential requirements of the directive. While these guidelines do not have legal value (only the official text of the directive does), they are often written in consultation with Member State authorities that enforce the directives.

Below is an excerpt of a table of harmonized standards for construction products, though not all tables have the same format:Harmonized standards for construction productsESOReference and title of the harmonised standard

(and reference document)Reference of superseded standardDate of applicability of the standard as a harmonised European standardDate of the end of the co-existence period Note 4CENEN 1:1998

EN 40-4:2005/AC:200601/01/200701/01/2Column 1: ESO, or the European Standards Organization, is the group responsible for the adoption and publication of EU standards. For the construction products above, the European Committee for Standardization (CEN) is the author.

Once you have identified the essential requirements in the directives and harmonized standards applicable to your product, you need to determine whether your product meets the applicable requirements, and whether you need to have a conformity assessment body test and certify your product to ensure that this is the case.

Some directives require that products be tested and certified by a third-party organization in order to ensure their conformity with applicable essential requirements. Whereas these organizations are known worldwide as conformity assessment bodies, they are also known in Europe as notified bodies (NB). If applicable directives do not require the use of an NB, manufacturers may rely on their own in-house facilities to assess their product’s conformity.

The EU has reduced the number of products that require NB assessment. The Low Voltage directive, for example, does not require the use of an NB. European authorities are increasingly putting the onus on manufacturers to prove their products are compliant.

Be prepared:To find the notified bodies appointed by European authorities to carry out conformity assessment, use NANDO - the New Approach Notified and Designated Organisationsdatabase. Manufacturers can search for a notified body by country and by directive. While the vast majority of notified bodies are located in Europe, a number of them have subsidiaries or contractual relations with certification bodies or testing laboratories located in Canada or in the United States to service North American clients.

How do you know that your product complies with the essential requirements in the applicable directives? You will have to test and document that your product actually conforms. Each directive outlines which conformity assessment procedures - also referred to as modules - a manufacturer can undertake. There are 8 conformity assessment modules. The applicable directives outline which module(s) apply for a particular product category.Module A: Internal production control

Notified body:ascertains, by performing or having performed examinations and tests, that the specimen(s) meet(s) the applicable provisions and is manufactured in accordance with the technical documentation

The manufacturer can hire a service provider for their access to test facilities but will pay simply for testing or other elements of conformity assessment, not consulting and certification, which is also what an NB is hired to do. A company can assess conformity of products by itself if it has the required facilities to test its product. This method is much less expensive.

The manufacturer is required to use an NB to assess conformity and certify its products, but it ultimately remains responsible for their conformity with EU essential requirements.

Conformity assessment to the European directives for CE marking may consist of different activities, including product testing, visual inspection, risk analysis as well as a review of product labels and instructions.

Many directives allow the manufacturer to choose among different conformity assessment procedures for the same product. Knowing all your options can yield significant savings in time and money.

All CE marking directives impose an obligation for the manufacturer to create and make available technical documentation (or a technical file) containing information that demonstrates that the product conforms to the requirements of the directive.

Technical documentation relevant to a CE-marked product must be kept for at least 10 years from the last date the product was manufactured, unless the directive provides for a later date. The technical documentation must be provided on demand to enforcement authorities, often within short timelines. The technical documentation needs to be kept up-to-date, especially when the product is modified or is subject to updated conformity assessment procedures.

Although several of the CE marking directives and European national laws impose that user information (e.g., user manuals) be translated into the official languages of the countries where they are sold, the rest of the technical documentation can be maintained in any EU language (including English or French).

EU law does not require that the technical documentation be located in Europe. The situation is different for the Declaration of Conformity (See step 6). However, EU importers must ensure that the exporter provides that file to EU enforcement authorities. Furthermore, EU importers or distributors marketing products under their own names are required to have a copy of the complete technical documentation.

If European harmonized standards have been applied then evidence of compliance is required. At a minimum this will be a dated list of the European harmonized standards applied and the results obtained on their application;

The document certifying compliance with CE marking directives is the Declaration of Conformity. The Declaration of Conformity is an acknowledgement by the manufacturer that they are responsible for the compliance of its products with the applicable directives.

The declaration should be available to authorities at the EU point of entry. Contrary to the complete technical documentation (which does not necessarily need to be shared with importers and distributors in some cases – see step 5), the Declaration of Conformity should be made available to EU distributors, who may be required to provide it to national authorities immediately upon request.

The CE mark must be affixed to all new products, whether manufactured in the Member States or in third countries; to used and second-hand products imported from third countries; and to substantially modified products that are subject to directives as new products.

Directives may exclude the application of the CE mark on certain products (specified below), even if the directive otherwise applies to the product. These specific exceptions vary from directive to directive.

The CE mark may not, in principle, be affixed until the conformity assessment procedure has been completed to ensure that the product complies with all the provisions of the relevant directives. This will usually be at the end of the production phase. However, if the CE mark forms an inseparable part of the product, or of a component, for example by stamping or casting, the mark can be affixed at any other stage of the production phase, provided that the conformity of the product is verified as appropriate throughout the production phase.

The CE marking shall, as a rule, be affixed to the product or to its data plate. However, it may instead be affixed to the packaging or to the accompanying documents if:affixing the mark is impossible

The CE mark consists of the letters ‘CE’, sometimes followed by the identification number of a notified body, as below. The identification number of the NB is added only when that NB has been involved in the production phase of the product.

Sometimes several notified bodies are involved in the production phase, where more than one directive is applicable. In these situations, several identification numbers follow the CE mark.

Be prepared:The CE mark must be easily seen and accessible for all parties. It could, for instance, be affixed on the back or underside of a product. A minimum height of 5 mm is required to ensure that it is legible. It shall also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces. (For example, some product standards use a rub test with water and petroleum spirits). However, this does not mean that the CE mark must form an integral part of the product.

The CE mark indicates that a product is compliant with all applicable directives and regulations – which in turn requires the CE mark. Such ‘CE marking directives’ and regulations apply to a wide range of products, including electronics, toys, helmets, sunglasses, and medical devices.

In this guide, we list the directives and regulations for which the CE mark is required. Each directive and regulation also includes a product list andother requirements that EU importers and manufacturers must be aware of.

The European Commission requires that manufacturers place the CE mark on their products if such products are covered by one or more of the CE marking directives or regulations. Additional requirements also apply, as we explain in the next section.

Currently, there are more than 20 CE marking directives and regulations. Each one covers a certain product scope and describes the technical and regulatory requirements for manufacturers, importers, and distributors.

Many CE marking directives and regulations do not list the specific products under their scope. Instead, these list the general product scope (e.g. input and output voltage). Therefore, it is sometimes confusing for manufacturers or importers to determine which particular directive or regulation applies to their products.

CE marking directives and regulations specify technical, regulatory, environmental, or other requirements for manufacturers, importers, or distributors. Each directive and regulation have different requirements for the product it covers. Here we summarized some general requirements:

The Radio Equipment Directive (RED) establishes a regulatory framework, including electrical safety, electromagnetic compatibility, radio spectrum use efficiency, and other circulation requirements, for the radio equipment placed in the EU market.

Note that radio equipment is defined as any electrical or electronic device that intentionally emits and/or receives aiming at radio communication and/or determination.

Also, according to the directive, if the manufacturer or importer demonstrates compliance via relevant harmonized standards, then the conformity assessment procedure might be completed without Notified Body involvement.

However, if the manufacturer or importer has not applied harmonized standards – or such standards do not exist for the product – then a Notified Body shall be required, either via EU-type examination or conformity based on full quality assurance.

According to Article 2 of the Directive, ‘radio equipment’ is defined as any electrical or electronic product that intentionally emits and/or receives radio waves for the purpose of radio communication. This can include WiFi, LTE, 5G, Bluetooth or GPS-enabled devices.

a. EN 303 354 V1.1.1 Amplifiers and Active Antennas for TV Broadcast Reception in Domestic Premises; Harmonised Standard Covering the Essential Requirements

b. EN 300 422-1 V2.1.2 Wireless Microphones; Audio Pmse Up to 3 GHz; Part 1: Class a Receivers; Harmonised Standard Covering the Essential Requirements

The RoHS Directive restricts the use of hazardous substances in electrical and electronic equipment (EEE) and establishes waste disposal methods for such products in order to protect human health and avoid environmental pollution.

The RoHS Directive applies to almost all electronic products placed in the European Union market, although there are some exemptions listed on the annexes of the directive.

b. EN IEC 63000: Technical Documentation for the Assessment of Electrical and Electronic Products with Respect to the Restriction of Hazardous Substances

The Ecodesign Directive sets up the regulatory framework for improving the performance of the so-called “energy-related products”, that is electrical and electronic products that might have a big impact on energy consumption.

The directive mainly sets compulsory requirements on the energy efficiency of household appliances and other products, with the goal of protecting the environment.

The Toy Safety Directive establishes safety requirements for toys and certain types of children’s products intended to be used by children under 14 years of age.

It requires that products under the scope of the directive must follow the technical requirements regarding the chemicals and heavy metals concentration limit, mechanical/physical properties specification, flammability rate, and more.

Annex I of the directive lists exempted products such as puzzles with more than 500 pieces, and bicycles with a maximum saddle height higher than 435 mm.

The Personal Protective Equipment (PPE) Regulation establishes designing and manufacturing requirements for personal protective equipment (PPE) placed in the EU market for the purpose of protecting the health and safety of the user, either on worksites or other places that present potential physical danger.

The regulation classifies PPE into Category I, II, or III, depending on the level of risk of the environment associated with their use. The hazardous levels are arranged in ascending order.

Annex I of the Personal Protective Equipment Regulation established three risk classes for which PPE is intended to protect users. Below we explain the differences among these classes.

contact with cleaning materials of weak action or prolonged contact with water; contact with hot surfaces not exceeding 50 °C or other types of relatively minor risks take place in the working environment. Examples of Category I PPE include:

Protective equipment that is intended for military use, self-defense, and resistance to non-extreme climate conditions are often exempted from the PPE Regulation, although there are some exemptions, which you can find in the text of the regulation itself.

The Construction Products Regulation (CPR) established rules and standards for products used for construction purposes in the EU. The Regulation provides a regulatory framework to assess the performance of construction products from the perspective of mechanical resistance, stability, flammability, health, environmental impact, and more.

According to Annex III of the regulation, when the product is covered by harmonized standards then Notified Body involvement might not be necessary in order to complete a declaration of performance.

“‘construction product’ means any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works;”

The Medical Devices Regulation applies to medical devices and their accessories and establishes a regulatory framework for the safety and health of the patients and users.

“This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.”

‘Medical Device’ can mean any instrument, apparatus, appliance, material, or other articles intended to be used for diagnosing, preventing, monitoring, predicting or alleviating disease, disability, physiological or pathological problems.

The regulation classifies medical devices into four classes: Class I, IIa, IIb, and III, where the medical devices of Class III hold the highest risk. The higher the number is, the stricter the rules that apply to the products.

Class IIa: Medical devices that have some potential low to medium risk and can generally be used for less than 30 days. Products belonging to this category include surgical gloves, hearing aids, and diagnostic ultrasound machines.

Class IIb: Medical devices that might constitute medium to high-risk to the patients and are generally designed to be used for more than 30 days. Products belonging to this category include long-term corrective contact lenses and surgical lasers.

Class III: Medical devices that have the potential highest risk. Products such as cardiovascular catheters, aneurysm clips, hip-joint implants, and prosthetic heart valves are considered as Class III medical devices.

a. EN IEC 60601: Medical Electrical Equipment – Part 2-83: Particular Requirements for the Basic Safety and Essential Performance of Home Light Therapy Equipment

b. EN ISO 17664: Processing of Health Care Products – Information to Be Provided by the Medical Device Manufacturer for the Processing of Medical Devices – Part 1: Critical and Semi-critical Medical Devices

The In-Vitro Diagnostic Medical Devices Regulation lays down rules and regulatory requirements for in-vitro diagnostic medical devices intended to be used by humans in the EU.

c. EN ISO 25424: Sterilization of Health Care Products – Low Temperature Steam and Formaldehyde Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

The Measuring Instruments Directive regulates measuring instruments placed in the market of the EU. In particular, according to the regulation, measuring instruments shall provide an accurate measurement.

This directive stipulates that, for all non-automatic weighing instruments, it is compulsory to conduct a product performance assessment and ensure the products meet all essential requirements of the EU legislation before being marketed among the member states of the EU. Notified Body involvement is generally required.

“This Directive, which comes under the SAVE programme concerning the promotion of energy efficiency in the Community, determines the efficiency requirements applicable to new hot-water boilers fired by liquid or gaseous fuels with a rated output of no less than 4 kW and no more than 400 kW, hereinafter called ‘boilers’.”

The Noise Emission in the Environment Directive regulates the noise emissions into the environment generated by machinery used in outdoor areas, including the conformity assessment procedure and technical documentation.

The directive provides two options for certification of the regulated outdoor machinery. When such equipment is subject to permissible sound power levels, the Notified Body involvement is required in the aspects of product design manufacturing procedures.

The Gas Appliances Regulation covers a wide range of household appliances function by means of burning gaseous fuels for the purpose of cooking, heating, refrigerating, lighting, and washing. The regulation establishes harmonized standards and procedures from the aspects of design, structure, and safety.

“ ‘appliances’ means appliances burning gaseous fuels used for cooking, refrigeration, air-conditioning, space heating, hot water production, lighting or washing, and also forced draught burners and heating bodies to be equipped with such burners.“

The Pressure Equipment Directive regulates pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar gauge in terms of safety requirements, product design, and manufacturing procedures.

The directive classifies pressure equipment into four categories, ranging from I to IV. The hazardous levels are arranged in ascending order. Conformity with the directive requires Notified Body involvement. Note, however, for a product classified under the category I is generally optional.

“ ‘pressure equipment’ means vessels, piping, safety accessories, and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs.”

The Simple Pressure Vessels Directive establishes procedures for simple pressure vessels in terms of design, manufacturing, safety, conformity assessment procedures, free movement, and other essential requirements for these products.

The Lifts Directive regulates lifts in terms of design, manufacture, components, installation, safety rules, and maintenance methods. The directive provides standards for manufacturers, importers and owners of lifts to refer to.

(c) goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier.”

The Cableway Installations Regulation sets up rules for cableways designed with the purpose of transporting people. This regulation involves requirements for the design, components, construction, subsystems, installations, infrastructure, operation, safety analysis, and the process of the cableway entry into service in the EU market.

a. EN 1709: Safety Requirements for Cableway Installations Designed to Carry Persons – Precommissioning Inspection, Maintenance, Operational Inspection and Checks

The Rail System Interoperability Directive sets standards for community rail systems concerning the design, construction, placement in service, upgrading, renewal, operation, and maintenance of the system, as well as the health condition of the staff who operate the system.

The ATEX Directive defines the essential health and safety requirements and conformity assessment procedures for equipment and protective systems used in an environment with potential explosive hazards in the EU market.

Most of the products regulated by this directive require Notified Body involvement. However, there are some exceptions, which can be found in Article 13 of the Directive

‘pyrotechnic article’ means any article containing explosive substances or an explosive mixture of substances designed to produce heat, light, sound, gas or smoke or a combination of such effects through self-sustained exothermic chemical reactions.”

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And yet a great specializing generalist may arise, who " can tell? Some twentieth-century Aristotle may be now tugging at his bottle, as little dreaming as are his parents or his friends of a conquest of the mind, beside which the wonderful victories of the Stagirite will look pale. The value of a really great student to the country is equal to half a dozen grain elevators or a new transcontinental railway.‎

Conference, recognising the importance of promoting greater freedom and fuller development of commercial intercourse within the Empire, believes that these objects may be best secured by leaving to each part of the Empire liberty of action in selecting the most suitable means for attaining them, having regard to its own special conditions and requirements, and that every effort should be made to bring about cooperation in matters of mutual interest.‎

That upon matters of importance requiring consultation between two or more Governments which cannot conveniently be postponed until the next Conference, or involving subjects of a minor character or such as call for detailed consideration, subsidiary Conferences should be held between representatives of the Governments concerned specially chosen for the purpose.‎

I say: Fear not! Life still Leaves human effort scope. But, since life teems with ill, Nurse no extravagant hope; Because thou must not dream, thou need"st not then despair ! A long pause.‎

A BROWN, sad-coloured hillside, where the soil Fresh from the frequent harrow, deep and fine, Lies bare; no break in the remote sky-line, Save where a flock of pigeons streams aloft, Startled from feed in some low-lying croft, Or far-off spires with yellow of sunset shine; And here the Sower, unwittingly divine, Exerts the silent forethought of his toil. Alone he treads the glebe, his measured stride Dumb in the yielding soil ; and though small joy Dwell in his heavy face, as spreads the blind Pale...‎

War, and, without wishing to commit any of the governments represented, recognizes and affirms the need of developing for the service of the Empire a General Staff, selected from the forces of the Empire as a whole...‎Less