The CE mark indicates that a product is compliant with all applicable directives and regulations – which requires the CE mark. As such, the CE mark can be found in various products, from bicycle helmets and sunglasses to power banks and face masks.
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 must be aware of.
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 require the involvement of a Notified Body.
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.
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.
Here some examples of products that fall under the Electromagnetic Compatibility (EMC) Directive:
- Washing machines
- LED walls
- AC adapters
- Electrical motors
Products that are classified as “inherently benign”, such as quartz watches, are exempted by the scope of the directive.
Radio Equipment Directive (RED)
The Radio Equipment Directive (RED) establishes a regulatory framework, including electrical safety, and 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.
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.
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)
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
- Automatic dispensers
- Lighting products
- Electrical medical devices
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.
Here we list some examples of products that fall under the Ecodesign Directive:
- Vacuum cleaners
- Electrical motors
- Welding equipment
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
- EN 71-4: Experimental sets for chemistry and related activities
- EN 71-5: Chemical toys (sets) other than experimental sets
- EN 71-6: Graphical symbols for age warning labeling
- EN 71-7: Finger paints
Note that, according to the directive, in some case, 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
Here some examples of products under the scope of the Toys Safety Directive:
- Wooden toys
- Fabric toys
- Education kits
- Finger paints
- Electronics toys
- Children’s furniture with play features
Annex I of the directive lists exempted products such as puzzles with more than 500 pieces, bicycles with a maximum saddle height higher than 435 mm.
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.
Here we list some examples of products that fall under the Personal Protective Equipment (PPE) Regulation:
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.
Construction Products Regulation
The Construction Products Regulation (CPR) established rules and standards for products used for construction purposes in the market of 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.
Here some examples of products that fall under the Construction Products Regulation (CPR):
- Steel beams
- Steel cables
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.
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 stethoscope 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
Here a shortlist of products that fall under the Medical Devices Regulation:
- Face masks and respirators
- Examination gloves
- Prescription glasses
- Medical diagnostic machinery
In Vitro Diagnostic Medical Devices, such as cotton swabs, pregnancy test strips are excluded, as they are covered by a specific regulation.
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 market of the EU.
This Regulation is also applicable to performance studies 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 of the human.
Note that Class A sterile, Class B, Class C, and Class D devices need Notified Body involvement.
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
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.
Here some examples of products that are covered by the Measuring Instruments Directive:
- Heat meters
- Gas meters
- Water meters
- Electricity metering equipment
- Dimensioning systems
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.
Examples of products under the Non-Automatic Weighing Instruments Directive:
- Retail scales
- Industrial scales
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.
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.
Here some machinery covered by the Machinery Directive:
- Sawing machinery
- Hydraulic presses
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.
Here some examples of products covered by Hot Water Boilers Directive:
- Standard boilers
- Low-temperature boilers
- Gas-condensing boilers
Conversely, here some examples of products exempted by the directive:
- Hot water boilers capable of being fired by multiple fuels
- Water heater for bathing and showering purposes
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.
There are 57 types of equipment covered by the directive, mainly used on construction sites, parks, gardens, and landfills.
Here some examples of products that fall under the Noise Emission in the Environment Directive:
- 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.
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.
Here 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.
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, that for a product classified under the category I is generally optional.
Here some examples of products regulated by the Pressure Equipment Directive:
- Pressure vessels
- Shell and water tube boilers
- Process pipeworks
- Relief valves
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.
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.
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.
The directive covers lifts permanently installed in buildings and construction sites.
Annex II of the directive lists exempted products, such as:
- Construction site hoists
- Lifts for military or police purposes
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.
The regulation covers cableways designed to transport people, while it doesn’t cover cableways designed to transport goods.
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 that have a hull length shorter than 12 meters, Notified Body involvement is generally required for compliance.
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.
Rail System Interoperability Directive
The Rail System Interoperability Directive sets standards for community rail systems concerning the design, construction, placing 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.
Railway vehicles are the main subject of this directive.
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
Here some examples of products covered by the directive, when used in an environment subject to explosie hazards:
- Industrial plugs
- Cable accessories
Conversely, here some examples of product 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
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.
This Directive applies to most explosives for civil uses.
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.
This Directive applies to pyrotechnic articles designed for commercial use, including:
- Stage pyro
- Products that produce war-gaming battle effects
- Seat-belt pre-tensioners