List of CE Marking Directives and Regulations: An Overview

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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 and other requirements that EU importers and manufacturers must be aware of.

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What are CE marking directives and regulations?

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.

Further, it is not allowed to print a CE mark on a product if such product is not covered by any EU legislation that requires the CE mark.

What are the requirements for CE marking directives and regulations?

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:

  • Declaration of Conformity
  • Technical File
  • Risk Assessment
  • Labeling
  • User instructions
  • Test Report
  • EU-type Examination Certificate (when the involvement of a notified body is required)

CE marking directives

Electric and Electronic Products

Low Voltage Directive (LVD)

The Low Voltage Directive regulates electrical and electronic equipment designed for use with a voltage rating of between 50 and 1,000 Volts for alternating current and between 75 and 1,500 Volts for direct current.

The directive requires that products under its scope must be safe for users under general circumstances and proper use.

The LVD is a self-assessed directive and, as such, doesn’t generally require the involvement of a Notified Body.

Product Scope

We quote from Article 1 of the Directive:


“This Directive shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, other than the equipment and phenomena listed in Annex II.”


Product Examples

Here we list some examples of products under the Low Voltage Directive (LVD):

Annex II of the Directive includes a list of exempted products, such as household plugs and sockets outlets.

Harmonised Standards (Examples)

a. EN 60335: Safety Requirements for Household and Similar Electrical Appliances

b. EN 60432: Safety Requirements for Incandescent Lamps

c. EN ISO 11252: Lasers and Laser-related Equipment – Laser Device – Minimum Requirements for Documentation

d. EN 60825: Safety Requirements for Laser Products

e. EN 60998: Requirements for Connecting Devices for Low Voltage Circuits for Household and Similar Purposes

Learn More

Electromagnetic Compatibility (EMC) Directive

The Electromagnetic Compatibility (EMC) Directive aims to regulate the electromagnetic emissions caused by electrical or electronic equipment in order to ensure that such products do not disturb the normal functioning of radio, telecommunication, and other electrical or electronic products, which shall still be able to operate as intended.

According to the product and installations, Notified Body involvement might be required. We suggest getting in touch with a reputable lab testing company to assess your specific case.

Product Scope

We quote from Article 2 of the Directive:


“This Directive shall apply to equipment as defined in Article 3.”


According to Article 3, “Equipment” is defined as any apparatus or fixed installation.

‘Apparatus’ means any appliance that generates electromagnetic disturbance or would be affected by the disturbance.

‘Fixed installation’ refers to a combination of apparatus intended to be used in a fixed location.

Product Examples

Here are some examples of products that fall under the Electromagnetic Compatibility (EMC) Directive:

  • E-bikes
  • Washing machines
  • LED walls
  • AC adapters
  • Electrical motors

Products that are classified as “inherently benign”, such as quartz watches, are exempted from the scope of the directive.

Harmonised Standards (Examples)

a. EN 13309: Construction Machinery – Electromagnetic Compatibility of Machines with Internal Power Supply

b. EN 55014: Electromagnetic Compatibility – Requirements for Household Appliances, Electric Tools and Similar Apparatus

c. EN 60669: Switches for Household and Similar Fixed Electrical Installations

Learn More

Radio Equipment Directive (RED)

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.

Product Scope

We quote from Article 1 of the Directive:


“This Directive establishes a regulatory framework for the making available on the market and putting into service in the Union of radio equipment.”


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.

Product Examples

Here we list some examples of radio equipment that fall under the Radio Equipment Directive (RED):

Note that Annex I of the directive lists some radio equipment that is excluded from the scope of the directive, such as amateur radio kits.

Harmonised Standards (Examples)

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

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RoHS Directive

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.

More specifically, the RoHS Directive restricts the use of several chemical substances, including:

  • Lead (Pb)
  • Mercury (Hg)
  • Cadmium (Cd)
  • Hexavalent chromium (Cr6+)
  • Polybrominated biphenyls (PBB)
  • Polybrominated diphenyl ether (PBDE)
  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Butyl benzyl phthalate (BBP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP)

Product Scope

We quote from Annex I of the Directive:


“Categories of EEE covered by this Directive

    • Large household appliances
    • Small household appliances
    • Consumer equipment
    • Lighting equipment
    • Electrical and electronic tools
    • Toys, leisure and sports equipment
    • Medical devices
    • Other EEE not covered by any of the categories above”

Product Examples

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.

The following are examples of products that fall under the RoHS Directive:

  • Electronic toys
  • Speakers
  • Earphones
  • Automatic dispensers
  • Lighting products
  • Electrical medical devices

Harmonised Standards (Examples)

a. EN 50581: Technical Documentation for the Assessment of Electrical and Electronic Products with Respect to the Restriction of Hazardous Substances

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

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Ecodesign Directive

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.

Besides the main Directive, there are specific regulations that detail the energy efficiency requirements for each of the 28 groups of products that fall into the scope of the directive.

Product Scope

We quote from Article 1 of the Directive:


“This Directive establishes a framework for the setting of Community ecodesign requirements for energy-related products with the aim of ensuring the free movement of such products within the internal market.”


According to Article 2 of the Ecodesign Directive, ‘Energy-related product’ means any goods and parts that have an impact on energy consumption during use.

Product Examples

Here we list some examples of products that fall under the Ecodesign Directive:

  • Heaters
  • Fans
  • Vacuum cleaners
  • Electrical motors
  • Welding equipment

Harmonised Standards (Examples)

a. EN 62552: Household refrigerating appliances – Characteristics and test methods

b. EN 61591: Household range hoods and other cooking fume extractors — Methods for measuring performance

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Toys Safety Directive

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.

The safety requirements of the Toy Safety Directive are compiled in the EN Standards 71 in 14 parts, including:

  • EN 71-1: Mechanical and physical properties
  • EN 71-2: Flammability
  • EN 71-3: Specification for migration of certain elements

Note that, according to the directive, in some cases, the conformity assessment procedure might require Notified Body involvement, including when:

  • No harmonized standards for the product exists
  • Harmonized standards exist but the manufacturer or importer didn’t apply them
  • The manufacturer or importer deems the use of a Notified Body necessary

Product Scope

We quote from Article 2 of the Directive:


“This Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys).”


Product Examples

Here are some examples of products under the scope of the Toys Safety Directive:

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.

Harmonised Standards (Examples)

a. EN 71-1: Mechanical and physical properties

b. EN 71-2: Flammability

c. EN 71-3: Specification for migration of certain elements

d. EN 71-4: Experimental sets for chemistry and related activities

e. EN 71-5: Chemical toys (sets) other than experimental sets

f. EN 62115: Electric Safety of Toys

Learn More

Personal Protective Equipment (PPE) Regulation

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.

Note that PPE that is classified as either Category II or III requires Notified Body involvement.

Product Scope

We quote from Article 2 of the Directive:


“This Regulation applies to PPE.”


Risk Categories and Product Examples

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.

Category I

Category I PPE are designed to protect the users from the risks of superficial mechanical injury;

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:

  • Gardening gloves
  • Cut-resistant gloves
  • Face masks
  • Ski goggles
  • Sunglasses

Category II

Category II PPE is designed to protect the users from medium risks such as physical, electrical, and chemical injuries that are not sufficient to cause death or irreversible damage to users. Examples of Category II PPE include:

  • Protective footwear
  • Reflective clothing
  • Bicycle helmets
  • Automatic welders’ protective filters
  • Laser adjustment filters

Category III

Category III PPE is designed to protect users from severe risks that could lead to death or irreversible damage to health. Examples of Category III PPE include:

  • Flame-retardant clothing
  • Anti-static protective clothing
  • Chemical protective coveralls

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.

Harmonised Standards (Examples)

a. EN 136: Respiratory Protective Devices – Full Face Masks – Requirements, Testing, Marking

b. EN 142: Respiratory Protective Devices – Mouthpiece Assemblies – Requirements, Testing, Marking

c. EN 352: Hearing Protectors: General Requirements – Part 1: Ear- Muffs

d. EN 342: Protective Clothing: Ensembles and Garments for Protection against Cold

e. EN 397: Industrial safety helmets

Learn More

Construction Products Regulation

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.

Conversely, when the product is not fully covered by relevant harmonized standards, a technical assessment body shall provide a European Technical Assessment.

Product Scope

We quote from Article 2 of the Directive:


“‘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;”


Product Examples

Here are some examples of products that fall under the Construction Products Regulation (CPR):

  • Lumber
  • Concrete
  • Steel beams
  • Steel cables
  • Rivets
  • Joints

Harmonised Standards (Examples)

a. EN 490: Concrete Roofing Tiles and Fittings for Roof Covering and Wall Cladding – Product Specifications

b. EN 517: Prefabricated Accessories for Roofing – Roof Safety Hooks

c. EN 1036: Glass in Building – Mirrors from Silver-coated Float Glass for Internal Use – Part 2: Evaluation of Conformity; Product Standard

Learn More

Medical Devices

Medical Devices Regulation

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.

Product Scope

We quote from Article 1 of the Directive:


“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.

Medical Devices Classes

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 I: Medical devices that have the lowest perceived risk. Products belonging to this category include stethoscopes and corrective glasses.

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.

Generally speaking, medical devices need the involvement of a Notified Body. The only exception is represented by medical devices of Class I that:

  • Are not placed in the market in a sterile condition
  • Do not have any measuring function

Product Examples

Here is a shortlist of products that fall under the Medical Devices Regulation:

In-Vitro Diagnostic Medical Devices, such as cotton swabs, and pregnancy test strips are excluded, as they are covered by a specific regulation.

Harmonised Standards (Examples)

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

Learn More

In-Vitro Diagnostic Medical Devices Regulation

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.

This Regulation is also applicable to performance studies on in-vitro diagnostic medical devices and accessories conducted in the EU.

According to the definition elaborated by this regulation, in-vitro diagnostic products are reagents, instruments, and systems used for the purpose of diagnosing disease or other conditions in humans.

Note that Class A sterile, Class B, Class C, and Class D devices need Notified Body involvement.

Product Scope

We quote from Article 1 of the Directive:


“This Directive shall apply to in-vitro diagnostic medical devices and their accessories”


Product Examples

Below you find some examples of products that fall under the In-Vitro Diagnostic Medical Devices Regulation:

  • Red / blue nasal swabs
  • Pregnancy test strips
  • Blood test kit
  • Urine test kit
  • Covid-19 test kit
  • HIV test kit

Harmonised Standards (Examples)

a. EN ISO 13485: Medical Devices – Quality Management Systems -requirements for Regulatory Purposes

b. EN ISO 15223: Medical Devices – Symbols to Be Used with Information to Be Supplied by the Manufacturer – Part 1: General Requirements

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

Learn More

Measurement Instruments

Measuring Instruments Directive

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.

Note that, according to the product, Notified Body involvement might be required.

Product Scope

We quote from Article 2 of the Directive:


“This Directive applies to the measuring instruments defined in the instrument-specific Annexes III to XII”


Please visit the Measuring Instruments Directive to learn more.

Product Examples

Here are some examples of products that are covered by the Measuring Instruments Directive:

  • Heat meters
  • Gas meters
  • Water meters
  • Electricity metering equipment
  • Taximeters
  • Dimensioning systems

Harmonised Standards (Examples)

a. EN 1359: Gas Meters – Diaphragm Gas Meters

b. EN 1434: Heat Meters

c. EN 12261: Gas Meters – Turbine Gas Meters

d. EN 14236: Ultrasonic Domestic Gas Meters

Learn More

Non-Automatic Weighing Instruments Directive

The Non-Automatic Weighing Instruments Directive sets down the regulatory requirements, specifications, and standards for weighing equipment for manufacturers and importers to conduct conformity assessments.

Product Scope

We quote from Articles 1 and 2 of the Directive:


Article 1

“This Directive shall apply to all non-automatic weighing instruments.”

Article 2

“ ‘non-automatic weighing instrument’ or ‘instrument’ means a weighing instrument requiring the intervention of an operator during weighing;”


Product Examples

Examples of products under the Non-Automatic Weighing Instruments Directive:

  • Retail scales
  • Industrial scales
  • Weighbridges

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.

Harmonised Standards (Examples)

EN 4550:1 Metrological Aspects of Non-Automatic Weighing Instruments

Learn More

Machinery

Machinery Directive

The Machinery Directive establishes technical requirements for a wide range of machinery in terms of design, structure, installation, and safety usage in all member states of the European Union.

According to article 12 of the directive, if the machinery is mentioned in Annex IV, for example, a circular saw and was not manufactured according to the relevant harmonized standards, or such standards do not fully cover all essential safety requirements, then the involvement of a Notified Body is needed.

Product Scope

We quote from Article 1 of the Directive:


“This Directive applies to the following products:

  • Machinery
  • Interchangeable equipment;
  • Safety components;
  • Lifting accessories
  • Chains, ropes and webbing
  • Removable mechanical transmission devices
  • Partly completed machinery”

Product Examples

Here is some machinery covered by the Machinery Directive:

  • Treadmills
  • Sawing machinery
  • Hydraulic presses
  • Chains
  • Ropes
  • Webbing

Harmonised Standards (Examples)

a. EN ISO 12100: Safety of Machinery – General Principles for Design – Risk Assessment and Risk Reduction

b. EN 349: Safety of Machinery – Minimum Gaps to Avoid Crushing of Parts of the Human Body

c. EN 614: Safety of Machinery – Ergonomic Design Principles – Part 1: Terminology and General Principles

d. EN 981: Safety of Machinery – System of Auditory and Visual Danger and Information Signals

e. EN 1837: Safety of Machinery – Integral Lighting of Machines

Learn More

Hot Water Boilers Directive

The Hot Water Boilers Directive sets out eco-design requirements as well as energy efficiency requirements for hot-water boilers with an output of no less than 4 kW and no more than 400 kW, operated in liquid or gaseous fuels.

Generally speaking, this directive requires the involvement of a Notified Body.

Product Scope

We quote from Article 1 of the Directive:


“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’.”


According to Article 2, ‘boiler’ means the combined boiler body-burner unit which is designed to transmit to water the heat released from burning.

Product Examples

Here are some examples of products covered by the Hot Water Boilers Directive:

  • Standard boilers
  • Low-temperature boilers
  • Gas-condensing boilers

Conversely, here are some examples of products exempted by the directive:

  • Hot water boilers are capable of being fired by multiple fuels
  • Water heater for bathing and showering purposes

Learn More

Noise Emission in the Environment Directive

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.

When the equipment is only subject to noise marking, manufacturers may choose the process of self-certification with necessary monitoring.

Product Scope

We quote from Article 2 of the Directive:


“This Directive applies to equipment for use outdoors listed in Articles 12 and 13 and defined in Annex I.”


According to Article 12, equipment subject to noise limits include:

  • Builders hoists for the transport of goods
  • Compaction machines
  • Hand-held concrete-breakers and picks,
  • Construction winches
  • Dozers
  • Dumpers

Please visit the Noise Emission in the Environment Directive to read the details.

Product Examples

There are 57 types of equipment covered by the directive, mainly used on construction sites, parks, gardens, and landfills.

Here are some examples of products that fall under the Noise Emission in the Environment Directive:

  • Dozers
  • Dumpers
  • Excavators
  • Lawn trimmers
  • Power generators

Note that the directive doesn’t cover equipment used as a means of transport of goods or passengers or for military purposes.

Learn More

Gas & Pressure Equipment

Gas Appliances Regulation

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.

Conformity with the Gas Appliances Regulation requires Notified Body involvement.

Product Scope

We quote from Articles 1 and 2 of the Directive:


Article 1

“This Regulation applies to appliances and fittings.”

Article 2

“ ‘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.“


Product Examples

Here are some examples of products that fall under the scope of the Gas Appliances Regulation:

  • Space heating machines
  • Cooking machines
  • Water heating machines

Note that the regulation doesn’t cover appliances designed to be used in industrial premises.

Harmonised Standards (Examples)

a. EN 26: Gas-fired Instantaneous Water Heaters for Sanitary Uses Production, Fitted with Atmospheric Burners

b. EN 30: Domestic Cooking Appliances Burning Gas – Part 1-1: Safety – General

c. EN 203: Gas Heated Catering Equipment – Part 1: General Safety Rules

Learn More

Pressure Equipment Directive

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.

Product Scope

We quote from Articles 1 and 2 of the Directive:


Article 1

“This Directive shall apply to the design, manufacture, and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.”

Article 2

“ ‘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.”


Product Examples

Here are some examples of products regulated by the Pressure Equipment Directive:

  • Pressure vessels
  • Shell and water tube boilers
  • Process pipe works
  • Relief valves

Harmonised Standards (Examples)

a. EN 334: Gas Pressure Regulators for Inlet Pressures Up to 100 Bar

b. EN 12178: Refrigerating Systems and Heat Pumps – Liquid Level Indicating Devices – Requirements, Testing, and Marking

c. EN 12778: Cookware – Pressure cookers for domestic use

Learn More

Simple Pressure Vessels Directive

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.

Generally speaking, the directive requires Notified Body involvement.

Product Scope

We quote from Article 1of the Directive:


“This Directive shall apply to simple pressure vessels (‘vessels’) manufactured in series with the following characteristics:

(a) the vessels are welded, intended to be subjected to an internal gauge pressure greater than 0,5 bar and to contain air or nitrogen, and are not intended to be fired;


Please read the Simple Pressure Vessels Directive to read the complete list of covered products.

Product Examples

The directive covers a wide range of vessels, including vessels welded, intended to be subjected to an internal gauge pressure greater than 0.5 bar containing air or nitrogen, and are not intended to be fired.

Harmonised Standards (Examples)

a. EN ISO 9606: Qualification Testing of Welders – Fusion Welding – Part 1: Steels

b. EN 10207: Steels for Simple Pressure Vessels – Technical Delivery Requirements for Plates, Strips and Bars

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Transportation

Lifts Directive

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.

This Directive generally requires Notified Body involvement.

Product Scope

We quote from Article 1of the Directive:


“…shall apply to lifts permanently serving buildings and constructions and intended for the transport of:

(a) persons;

(b) persons and goods;

(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.”


Product Examples

The directive covers lifts permanently installed in buildings and construction sites.

Annex II of the directive lists exempted products, such as:

  • Construction site hoists
  • Cableways
  • Lifts for military or police purposes

Harmonised Standards (Examples)

a. EN 81: Safety Rules for the Construction and Installation of Lifts – Lifts for the Transport of Persons and Goods – Part 20: Passenger and Goods Passenger Lifts

b. EN 12016: Electromagnetic Compatibility – Product Family Standard for Lifts, Escalators and Moving Walks – Immunity

c. EN 12385: Steel Wire Ropes – Safety – Part 3: Information for Use and Maintenance

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Cableway Installations Regulation

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.

Note that the conformity assessment procedures specified by this Regulation require Notified Body involvement.

Product Scope

We quote from Article 2 of the Directive:


“This Regulation applies to new cableway installations designed to transport persons, to modifications of cableway installations requiring a new authorization, and to subsystems and safety components for cableway installations.”


Product Examples

The regulation covers cableways designed to transport people, while it doesn’t cover cableways designed to transport goods.

Harmonised Standards (Examples)

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

b. EN 1908: Safety Requirements of Cableway Installations Designed to Carry Persons – Tensioning Devices

c. EN 1909: Safety Requirements for Cableway Installations Designed to Carry Persons – Recovery and Evacuation

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Recreational Craft Directive

The Recreational Craft Directive sets out requirements for the design, manufacture, and free movement rules of recreational crafts and the components of these products within the member states of the European Union.

Excluding some crafts with a hull length shorter than 12 meters, Notified Body involvement is generally required for compliance.

Product Scope

We quote from Article 2 of the Directive:


“This Directive shall apply to the following products:

(a) recreational craft and partly completed recreational craft;

(b) personal watercraft and partly completed personal watercraft;

(c) components listed in Annex II when placed on the Union market separately, hereinafter referred to as ‘components’;…


You can find the full list of covered products in the official text of the Cableway Installations Regulation.

Product Examples

This directive covers product such as:

  • Personal watercraft powered by engines
  • Craft propulsion engines

Crafts that are propelled solely by human power, such as canoes, kayaks, gondolas, pedalos, surfboards are excluded.

Harmonised Standards (Examples)

a. EN ISO 7840: Small craft – Fire-resistant fuel hoses

b. EN ISO 8099: Small craft – Waste systems – Part 1: Waste water retention

c. EN ISO 9094: Small craft – Fire protection

d. EN ISO 9097: Small craft – Electric fans

e. EN ISO 10087: Small craft – Craft identification – Coding system

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Rail System Interoperability Directive

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.

This directive requires the involvement of a Notified Body.

Product Scope

We quote from Article 1 of the Directive:


“This Directive applies to the rail system in the Member States, which may be broken down into subsystems for structural and functional areas.”


Product Examples

Railway vehicles are the main subject of this directive.

Harmonised Standards (Examples)

a. EN 12665: Light and Lighting – Basic Terms and Criteria for Specifying Lighting Requirements

b. EN 13103: Railway Applications – Wheelsets and Bogies – Non-powered Axles – Design Method

c. EN 61375: Electronic Railway Equipment – Train Communication Network (tcn)

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Explosives

Equipment for Explosive Atmospheres (ATEX) Directive

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

Product Scope

We quote from Article 1 of the Directive:


“This Directive shall apply to the following, hereinafter referred to as ‘products’:

(a) equipment and protective systems intended for use in potentially explosive atmospheres;


Please visit the Equipment for Explosive Atmospheres (ATEX) Directive to read the detailed information.

Product Examples

Here are some examples of products covered by the directive, when used in an environment subject to explosive hazards:

  • Lighting
  • Enclosures
  • Industrial plugs
  • Cable accessories
  • Sockets

Conversely, here are some examples of products that aren’t covered by the directive:

  • Medical devices used in the medical environment
  • Domestic-used equipment where the environment is generally safe
  • Personal protective equipment covered by the PPE Regulation

Harmonised Standards (Examples)

a. EN 1127: Explosive Atmospheres – Explosion Prevention and Protection

b. EN 1710: Equipment and Components Intended for Use in Potentially Explosive Atmospheres in Underground Mines

c. EN 1755: Industrial Trucks – Safety Requirements and Verification – Supplementary Requirements for Operation in Potentially Explosive Atmospheres

d. EN 1953: Atomising and Spraying Equipment for Coating Materials – Safety Requirements

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Explosive for Civil Use Directive

The Explosive for Civil Use Directive regulates the safety aspects, authorizations, and liability of manufacturing, importing and selling civil explosives products in the EU, and it requires Notified Body involvement.

Product Scope

We quote from Article 1 and 2 of the Directive:


Article 1

“This Directive shall apply to explosives for civil uses.

Article 2

‘explosives’ means the materials and articles considered to be explosives in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations.”


Product Examples

This Directive applies to most explosives for civil uses.
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Harmonised Standards (Examples)

a. EN 13630: Explosives for civil uses – Detonating cords and safety fuses – Part 1: Requirements

b. EN 13631: Explosives for civil uses – High explosives

c. EN 13763: Explosives for civil uses – Detonators and relays

d. EN 13938: Explosives for civil uses – Propellants and rocket propellant

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Pyrotechnic Articles Directive

This directive sets up safety rules and market circulation rules for pyrotechnic articles in the member states of the European Union, and it requires the involvement of a Notified Body.

Product Scope

We quote from Articles 1 and 2 of the Directive:
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Article 1

“This Directive shall apply to pyrotechnic articles.”

Article 2

“For the purposes of this Directive, the following definitions shall apply:

‘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.”


Product Examples

This Directive applies to pyrotechnic articles designed for commercial use, including:

  • Fireworks
  • Stage pyro
  • Products that produce war-gaming battle effects
  • Seat-belt pre-tensioners

Harmonised Standards (Examples)

a. EN ISO 14451: Pyrotechnic Articles – Pyrotechnic Articles for Vehicles

b. EN 15947: Pyrotechnic Articles – Fireworks, Categories F1, F2 and F3

c. EN 16256: Pyrotechnic Articles – Theatrical Pyrotechnic Articles

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
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