List of Products Covered by CE Marking: An Overview

Planning to import and sell products in the European Union, but not sure if your products must be CE marked? In this guide, we list toys, watches, electronics and other products that fall within the scope of one or more CE marking directives.

What is CE Marking

The CE mark is a mandatory compliance mark, informing the consumer that the product is compliant with all applicable EU directives/regulations for which the CE mark is required. Here are some regulations for which the CE mark is mandatory:

• RoHS
• Low Voltage Directive
• Toy Safety Directive
• Personal Protective Equipment Directive
• Medical Devices Directive
• Machinery Directive

As such, the CE mark can be found on everything from phone chargers and game consoles to bike helmets, sunglasses and teddy bears. Keep in mind that the CE mark is not optional in case one or more “CE directives” apply to your product. Likewise, products falling outside the scope of such directives/regulations should not be CE marked.

Toys

Toys products designed or intended for use by children under 14 years of age are covered under the Toy Safety Directive and, as such, need to be CE marked.

In order to comply with the directive, besides preparing all the relevant documentation such as DoC and technical file, your toys shall also comply with the EN 71 standards.

Here are some example of EN 71 standards:

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

If you are planning to import electronic toys, you shall comply with both EN 71 and EN 62115 standards.

Examples

• Wooden toys
• Electronic toys
• Plastic toys
• Educational toys

Electronics

All electronics products are covered by one or more CE marking directive and, as such, they must be CE marked. Here you find a list of the most common CE directives that apply to electronics products.

RoHS Directive

The RoHS Directive regulates certain hazardous substances (e.g lead and mercury) in electrical and electronic equipment.

Low Voltage Directive

The Low Voltage Directive (LVD) only applies to electronics products operating with an input or output voltage between:

• 50 and 1000 V for alternating current
• 75 and 1500 V for direct current

Many consumer and industrial electrical equipment would fall into the scope of LVD such as household appliances, laser equipment, and alternators.

EMC Directive

The EMC Directive regulates electronics products that might cause electromagnetic interference with other devices, such as TVs and house appliances.

Radio Equipment Directive

The Radio Equipment Directive (or RED) regulates both safety and electromagnetic interference of radio equipment such as Wi-Fi, RFID, and Bluetooth devices.

Examples

• Bluetooth speakers
• USB flash drive
• Computer laptop
• Electric razor
• Digital cameras
• Video game consoles
• Paper shredders
• Printers

Wrist Watches

Electronics wristwatches are covered by the RoHS directive, which as said restricts heavy metals in electronic components and metallic parts in contact. In addition, smartwatches are also covered by the RED. As such, any watches that contain electronics components must be CE marked.

Examples

• Electronic wristwatches
• Quartz watches
• Smartwatches

Note that the RoHS and RED are not applicable to automatic and mechanical watches.

AC Adapters

Many AC adapters are regulated by LVD, EMC, and RoHS Directives. In particular, LVD applies to most AC adapters as they normally have input voltage ranging from 110 up to 240 volts AC. As explained above, products that work at these voltages follow under the LVD.

Examples

• Laptop AC adapters
• Interchangeable Medical AC adapters
• Universal power AC adapters

LED Lighting Products

LED lighting products are covered by one or more CE marking Directive and, as such, they must be CE marked.

For instance, the RoHS Directive applies to all LED lighting products; the LVD applies to all LED lighting that has a voltage range in 50 to 1000V AC or 120 to 1500V DC, and the EMC applies to LED lighting that causes interference with other electronic devices.

Also, the Ecodesign directive applies to all LED lighting products (except for the use in theatres or museums), and the RED applies to smart LED lighting that are featured with Wi-Fi, Bluetooth or 3G/4G/LTE devices.

Examples

• LED light strips
• LED billboard
• LED lamps
• Smart LED light bulbs

Sunglasses

Sunglasses and other eyewear products are classified as Personal Protective Equipment (PPE) in the European Union. Most sunglasses placed in the market are categorized into Category I under the PPE Directive and, as such, they must be CE marked.

The PPE directive provides specific EN standards that apply to sunglasses and eyewear. EN standards are usually voluntary however it is beneficial for importers to create a presumption of conformity.

Examples

• Polarized sunglasses
• Prescription sunglasses
• Sports sunglasses
• Performance sunglasses

Personal Protective Equipment (PPE)

All PPEs are covered by the PPE Directive and must be CE marked. PPE refers to all equipment intended to protect the user against hazards such as falling objects and collision, and it might cover both workwear and sportswear.

Importers shall classify their PPE products according to the Directive guidelines, then comply with relevant requirements. Here is an overview of the PPE category classifications:

Category I: Simple PPE designed to protect users to reduce minimal risks. For example sunglasses, eye protectors for dust, safety gloves, and earplugs.

Category II: Intermediate PPE to protect users from physical, electrical, and chemical injury. For example safety spectacles, work helmets, protective clothing.

Category III: PPE products that protect against serious consequences such as death or irreversible damage to health. For example eye protectors for using at extremely intensive IR radiation environments, and protective breathing apparatus.

Examples

• Safety helmets
• Safety gloves
• Eye protectors
• Safety shoes

You can learn more about importing sunglasses & eyewear products in this guide.

Machinery

The Machinery Directive covers most machinery imported and sold in the EU market. If your products match the definition provided by the directive as below, you will need to comply with the Machinery directive and attach a CE mark on the products:

• Interchangeable equipment
• Safety components
• lifting accessories
• Removable mechanical transmission devices
• Ropes, chains, and webbing

For products that utilize both human and non-human effort, to apply forces and control movement to perform an intended action, it is considered as a machine and it is covered under the machinery directive.

Examples

• Treadmill
• Rowing machine
• Hot steel rolling machines
• Ready-mix concrete trucks
• Drill presses

Bicycles

Most bicycles placed in the market are considered as transportation vehicles, and they are not covered by CE directives. For instance, you do not need to CE mark road bikes, BMX bikes or mountain bikes.

However, if the bicycle’s saddle height is less than 435 mm, then it is considered as a toy bicycle and it is covered by the Toy Safety Directive. As such, you will need to comply with EN 71 standards and CE mark the products.

Also, if you are planning to import and sell E-bikes into the EU market, certain CE Directive applies. For example, most E-bikes would fall into the scope of the Machinery, RoHS, and EMC directives.

Therefore, E-bikes and toy bicycles are covered by CE directives and must be CE-marked.

Examples

• E-bikes
• Toy bicycle

Medical Devices

The Medical Devices Directive is a CE directive, which applies to medical devices and their accessories placed in the EU market. Medical devices are defined as any instrument, apparatus, appliance, software, implant, reagent, material or another article intended to be used for medical purposes, such as:

• Medical diagnosis
• Medical treatment
• Alleviation of disease
• Prevention of disease

In addition, certain types of products are also considered as medical devices, such as:

• Products for cleaning, disinfection, and sterilization of medical devices
• Devices for the control and support of conception

CE marking is required for all products that fall into the scope of the medical devices directive.

Examples

• Medical masks
• Plastic syringes
• Medical thermometers
• Glucose meters
• Oxygen concentrators ventilators
• Medical nebulizes

Note that the medical devices directive does not apply to the following devices:

• In vitro diagnostic devices
• Active implantable devices
• Medicinal products derived from blood
• Cosmetic products

Construction Materials

Construction products are regulated by the Construction Products Regulation (CPR) which is also a CE directive. The CPR aims to improve the performance of construction products and achieve the proper functioning of the internal market in the EU.

Any product or kit which is produced and placed on the market for construction works such as buildings and civil engineering works, it is considered as a construction material, and it shall comply with the CPR. Also, the CPR applies to construction products that have either direct or indirect effects on the performance of the construction works.

Harmonized standards can be used to assess the performance of construction products, and affix the CE marking if it satisfies the requirements.

Additional Resources

1. CE Marking (European Commission Website)

2. List of CE Marking Service Companies

3. List of RoHS Lab Testing Companies

4. List of EMC Directive Testing Companies:

5. List of Low Voltage Directive (LVD) Lab Testing Companies

6. List of EN 71 Lab Testing Companies