EU CE Marking Guide: Directives, Regulations & Standards

The ce marking indicates that a product complies with the relevant CE directives and regulations. These regulations apply to a wide range of products, including electronics, toys, helmets, sunglasses, and medical devices.

This guide provides a detailed overview of the main EU directives and regulations that require the CE marking. It also explains product examples and requirements that EU importers and manufacturers need to pay attention to, while preserving relevant harmonized standards (examples) for practical use and technical reference.

1. What Are CE Marking Directives and Regulations?

* The EU requires that if a product complies with one or more CE directives or regulations, importers and manufacturers must affix the CE marking to their products.

* Currently, there are over thirty such directives and regulations, covering a wide scope with varying requirements.

* Most directives use technical characteristics for applicability rather than product names, so determining which rules apply depends on your specific product.

2. What Are the Requirements of CE Marking Directives and Regulations?

* Compliance with relevant harmonized standards and technical specifications

* Declaration of Conformity (DoC)

* Technical documentation

* Risk assessment

* Labeling and user instructions

* Test reports

* EU Type Examination Certificate (if notified body involvement is required)

3. Key Product Categories and Related Directives/Regulations (With Harmonized Standards)

1. Ecodesign for Sustainable Products Regulation

a. Scope: All physical goods placed on the EU market, including components and intermediate products.

b. Product Examples: Apparel, footwear, furniture, electronics

c. Harmonized Standards (Examples): None specified as of writing.

2. Electrical and Electronic Products

low voltage directive (LVD)

1. Product Examples: Lamps, charging cables, electric hair appliances, outdoor electric grills

2. Harmonized Standards (Examples):

* EN 60335-2-2 Household and similar electrical appliances—Vacuum cleaners

* EN 60432-2 Incandescent lamps—Tungsten halogen lamps

* EN ISO 11252 Laser equipment

* EN ISO 60825-2 Safety of laser products—Fibre communication systems

* EN 60998-1 Low-voltage connecting devices

Electromagnetic Compatibility (EMC) Directive

1. Product Examples: Taxi meters, sewing machines, fire alarm systems, lighting equipment

2. Harmonized Standards (Examples):

* EN 1155 Electrically powered hold-open devices for swing doors

* EN 55014-1 EMC—Household appliances—Emission

* EN 60669-2-1 Switches for fixed installations—Electronic switches

Radio Equipment Directive (RED)

1. Product Examples: Wireless microphones, laptops, smartwatches, routers, WiFi devices

2. Harmonized Standards (Examples):

* EN 303 354 Amplifiers and active antennas for home TV broadcast reception

* EN 302 077 Digital audio broadcasting (DAB) transmission equipment

* EN 300 433 Citizen band (CB) radio equipment

RoHS Directive

1. Product Examples: Electronic toys, vending machines, lighting products, household appliances, medical devices

2. Harmonized Standards (Examples):

* EN IEC 63000 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances

Ecodesign Directive

1. Product Examples: Light sources, ovens, dishwashers, heaters, fans, refrigerators

2. Harmonized Standards (Examples):

* EN 60436 Household electric dishwashers—Performance measurement

* EN 30-2-1 Gas cooking appliances—Energy efficiency

* EN 14511-2 Air conditioners and heat pumps—Testing conditions

* EN 62552 Household refrigerating appliances—Characteristics and test methods

Battery Regulation

1. Product Examples: Portable batteries, electric vehicle batteries, industrial batteries

2. Harmonized Standards (Examples) (most are in draft):

* prEN 18060 Performance of rechargeable batteries for EVs

* prEN 18061 Safety, servicing, and reuse of batteries for EVs

* prEN IEC 60086-1 Primary batteries—General

* prEN IEC 60086-2-1 Primary batteries—Aqueous electrolyte

3. Toy Safety Directive

a. Product Examples: Foam floor puzzles, plush toys, electric toys

b. Harmonized Standards (Examples):

* EN 71-1 Safety of toys—Mechanical and physical properties

* EN 71-2 Safety of toys—Flammability

* en 71-3 Safety of toys—Migration of certain elements

* EN 71-4, EN 71-5 Chemical experimental sets and toys

* EN 62115 Electric toys—Safety

4. Personal Protective Equipment (PPE) Regulation

a. Risk Categories/Product Examples:

* Category I: Sunglasses, gardening gloves, cut-resistant gloves

* Category II: Bicycle helmets, safety shoes, high-visibility clothing

* Category III: Flame-retardant suits, anti-static protective clothing, chemical protective suits

b. Harmonized Standards (Examples):

* EN 136 Respiratory protective devices—Full face masks

* EN 142 Mouthpiece assemblies

* EN 352-1 Hearing protectors—Ear muffs

* EN 342 Protective clothing—Ensembles and garments for protection against cold

* EN 397 Industrial safety helmets

5. Construction Products Regulation

a. Product Examples: Doors, windows, flooring, roof lights

b. Harmonized Standards (Examples):

* EN 490 Concrete roofing tiles and fittings

* EN 517 Roof safety hooks

* EN 1036 Interior silvered float glass mirrors for buildings

* EN 13015 Maintenance for lifts and escalators

6. Medical Device regulations

Medical Device Regulation

1. Product Examples: Masks, examination gloves, prescription glasses, diagnostic devices

2. Harmonized Standards (Examples):

* EN iec 60601-2-83 Medical electrical equipment—Phototherapy equipment

* EN ISO 17664-1 Information for processing of medical devices

In Vitro Diagnostic Medical Devices Regulation

1. Product Examples: Nucleic acid test kits, FSH fertility devices, HPV testing devices

2. Harmonized Standards (Examples):

* EN ISO 11135 Sterilization of health care products—Ethylene oxide

* EN ISO 13408-1 Aseptic processing—General requirements

* EN ISO 15223-1 Medical devices—Symbols for information to be supplied

* EN ISO 25424 Sterilization—Low temperature steam and formaldehyde

7. Measuring Instruments Directives

Measuring Instruments Directive

1. Product Examples: Heat meters, gas meters, water meters, electricity meters

2. Harmonized Standards (Examples):

* EN 1359 Diaphragm gas meters

* EN 12405-1 Conversion devices

* EN 12261 Turbine gas meters

* EN 14236 Ultrasonic gas meters

Non-automatic Weighing Instruments Directive

1. Product Examples: Retail scales, industrial scales, weighbridges

2. Harmonized Standards (Examples):

* EN 45501 Metrological aspects of non-automatic weighing instruments

8. Machinery and Machinery Safety Directives

1. Product Examples: Handheld drain cleaners, table saws, electric lawnmowers, steam cleaners

2. Harmonized Standards (Examples):

* EN ISO 12100 Safety of machinery—General principles

* EN 1837 Safety of machinery—Integral lighting

* EN ISO 13849-1 Safety-related parts of control systems

* EN 1870-6 Woodworking machines—Circular saw machines

9. Outdoor Noise Emission Directive

Product Examples: Bulldozers, dumpers, excavators, lawn mowers, generators

Harmonized Standards (Examples): Refer to the specific equipment.

10. Artificial Intelligence Regulation

Product Examples: Biometric identification systems, infrastructure management, education/employment AI, law enforcement systems

Harmonized Standards (Examples): See EU AI Act supporting standards and high-risk AI technical files.

11. Unmanned Aircraft Systems Regulation

Product Examples: Drones for hazardous goods transport, drones for people, remote ID drones

Harmonized Standards (Examples):

* EN 4709-002 Unmanned aircraft systems—Direct remote identification

12. Hot Water Boiler Directive

Product Examples: Standard boilers, low temperature boilers, condensing gas boilers

Harmonized Standards (Examples): See the relevant boiler equipment standards.

13. Gas and Pressure Equipment Regulations

Gas Appliances Regulation

1. Product Examples: Space heaters, cookers, water heaters

2. Harmonized Standards (Examples):

* EN 30-1-1 Gas cooking appliances—Safety

* EN 30-1-2 Gas cooking appliances

* EN 203-1 Gas heated catering equipment

* EN 15502-1 Gas-fired heating boilers

Pressure Equipment Directive

1. Product Examples: Pressure vessels, piping, pressure accessories

2. Harmonized Standards (Examples):

* EN 334 Gas pressure regulators

* EN 12178 Liquid level indicators

* EN 12778 Domestic pressure cookers

Simple Pressure Vessels Directive

1. Product Examples: Mass-produced welded simple pressure vessels

2. Harmonized Standards (Examples):

* EN ISO 9606 Qualification testing of welders

* EN 10207 Steel for simple pressure vessels

14. Transport-related Directives

Lifts Directive

1. Product Examples: Permanently installed building lifts

2. Harmonized Standards (Examples):

* EN 81-20 Safety rules for passenger and goods lifts

* EN 81-73 Lift behavior in the event of fire

* EN 12016 Electromagnetic compatibility

* EN 13015 Lift and escalator maintenance

Cableway Installations Regulation

1. Product Examples: New passenger cableway installations

2. Harmonized Standards (Examples):

* EN 1709 Safety requirements for passenger cableways

* EN 1908 Tensioning devices

* EN 1909 Recovery and evacuation

* EN 13796-2 Grips—Slip resistance test

Recreational Craft Directive

1. Product Examples: Motorboats, propulsion engines

2. Harmonized Standards (Examples):

* EN ISO 7840 Small craft—Fire-resistant fuel hoses

* EN ISO 9094 Small craft—Fire protection

* EN ISO 10087 Craft identification

* EN ISO 10088 Permanent fuel systems

* EN ISO 16180 Navigation lights—Installation and visibility

Railway Interoperability Directive

1. Product Examples: Railway vehicles, track equipment

2. Harmonized Standards (Examples):

* EN 12663-2 Railway vehicle body structure

* EN 13232-3 Switches and crossings

* EN 61375-2-1 Train communication network

* EN 62621 Composite insulators for overhead contact lines

15. Explosives and Related Products Regulations

ATEX Directive for Equipment in Explosive Atmospheres

1. Product Examples: Fans, vacuum cleaners, electrostatic spraying equipment

2. Harmonized Standards (Examples):

* EN 1127-1 Explosion prevention and protection

* EN 14986 Design of fans for explosive atmospheres

* EN 1755 Supplementary requirements for industrial trucks

* EN 17348 Design of vacuum cleaners for explosive atmospheres

Civil Explosives Directive

1. Product Examples: Detonators, explosives

2. Harmonized Standards (Examples):

* EN 13630-1 Detonating cords and safety fuses

* EN 13631-2 High explosives—Thermal stability

* EN 13763-3 Detonators—Impact sensitivity

* EN 13938-1 Propellants—Requirements

Pyrotechnic Articles Directive

1. Product Examples: Fireworks, vehicle pyrotechnics

2. Harmonized Standards (Examples):

* EN ISO 14451-8 Vehicle pyrotechnic articles

* EN 15947-4 Fireworks—Test methods

* EN 16256-3 Stage pyrotechnic articles—Requirements and performance

* EN 16261-3 Fireworks—Test methods

Fertilizing Products Regulation

1. Product Examples: Fertilizers, lime, soil improvers

2. Harmonized Standards (Examples):

* EN 17816 Lime materials—Physical and chemical properties

* EN 17817 Fertilizers and lime—Content determination

* EN 12580 Soil improvers—Content determination

* EN 15560 Inorganic fertilizers—Total nitrogen

* EN 12946 Lime materials—Calcium and magnesium content