List of CE Marking Directives and
Regulations: An Overview
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.
Content Overview
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Electric and Electronic Products
o Low Voltage Directive (LVD)
o Electromagnetic Compatibility (EMC) Directive
o Radio Equipment Directive (RED)
o RoHS Directive
o Ecodesign Directive
Toys Safety Directive
Personal Protective Equipment (PPE) Regulation
Construction Products Regulation
Medical Devices
o Medical Devices Regulation
o In Vitro Diagnostic Medical Devices Regulation
Measurement Instruments
o Measuring Instruments Directive
o Non-Automatic Weighing Instruments Directive
Machinery
o Machinery Directive
o Hot Water Boilers Directive
o Noise Emission in the Environment Directive
Gas & Pressure Equipment
o Gas Appliances Regulation
o Pressure Equipment Directive
o Simple Pressure Vessels Directive
Transportation
o Lifts Directive
o Cableway Installations Regulation
o Recreational Craft Directive
o Rail System Interoperability Directive
Explosives
o Equipment for Explosive Atmospheres (ATEX) Directive
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Explosive for Civil Use Directive
Pyrotechnic Articles Directive
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.
Product Examples
Here we list some examples of products under the Low Voltage Directive
(LVD):
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AC adapters
 LED lighting
 Electrical coffee machines
 Kitchen mixers
 Hairdryers
Annex II of the Directive includes a list of exempted products, such as
household plugs and sockets outlets.
Learn More
a. Low Voltage Directive for EU For Importers
b. List of Products Covered by the Low Voltage Directive
c. Official Text of the Directive
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 Examples
Here some examples of products that fall under the Electromagnetic
Compatibility (EMC) Directive:
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E-bikes
 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.
Learn More
a. List of Products Covered by the EMC Directive
b. Official Text 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.
Product Examples
Here we list some examples of radio equipment that fall under the Radio
Equipment Directive (RED):
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Bluetooth speakers
 Bluetooth earphones
 RFID devices
 Smartphones
 Smart TVs
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.
Learn More
a. List of Products Covered by the Radio Equipment Directive (RED)
b. Official Text of the Directive
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:
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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 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:
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Electronic toys
Speakers
Earphones
Automatic dispensers
Lighting products
Electrical medical devices
Learn More
a. List of Products Covered by RoHS
b. Official Text of the Directive
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 Examples
Here we list some examples of products that fall under the Ecodesign
Directive:
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Heaters
Fans
Vacuum cleaners
Electrical motors
Welding equipment
Learn More
a. List of Products Covered by the Ecodesign Directive
b. Official Text of the Directive
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:
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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:
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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 Examples
Here some examples of products under the scope of the Toys Safety
Directive:
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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.
Learn More
a. List of Products Covered by the Toy Safety Directive (EN 71)
b. Official Text of the Directive
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 Examples
Here we list some examples of products that fall under the Personal Protective
Equipment (PPE) Regulation:
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Sunglasses
 Face masks and respirators
 Helmets
 Working gloves
 Safety goggles
 Earmuffs
 Earplugs
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.
Learn More
a. List of Products Covered by the PPE Regulation
b. Official Text of the Regulation
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.
Product Examples
Here some examples of products that fall under the Construction Products
Regulation (CPR):
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Lumber
Concrete
Steel beams
Steel cables
Rivets
Joints
Learn More
a. Official Text of the Regulation
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.
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:
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Are not placed in the market in a sterile condition
Do not have any measuring function
Product Examples
Here a shortlist of products that fall under the Medical Devices Regulation:
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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.
Learn More
a. Medical Devices Directive
b. List of Products Covered by the Medical Devices Directive
c. Official Text of the 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.
Product Examples
Below you find some examples of products that fall under the In Vitro
Diagnostic Medical Devices Regulation:
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Red / blue nasal swabs
Pregnancy test strips
Blood test kit
Urine test kit
Covid-19 test kit
HIV test kit
Learn More
a. Official Text of the Regulation
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 Examples
Here some examples of products that are covered by the Measuring
Instruments Directive:
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Heat meters
Gas meters
Water meters
Electricity metering equipment
Taximeters
Dimensioning systems
Learn More
a. Official Text of the Directive
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 Examples
Examples of products under the Non-Automatic Weighing Instruments
Directive:
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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.
Learn More
a. Official Text of the Directive
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 Examples
Here some machinery covered by the Machinery Directive:
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Treadmills
Sawing machinery
Hydraulic presses
Chains
Ropes
Webbing
Learn More
a. List of Products Covered by the Machinery Directive
b. Official Text of the Directive
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 Examples
Here some examples of products covered by Hot Water Boilers Directive:
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Standard boilers
 Low-temperature boilers
 Gas-condensing boilers
Conversely, here some examples of products exempted by the directive:
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Hot water boilers capable of being fired by multiple fuels
Water heater for bathing and showering purposes
Learn More
a. Official Text of the Directive
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 Examples
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:
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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
a. Official Text of the Directive
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 Examples
Here some examples of products that fall under the scope of the Gas
Appliances Regulation:
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Space heating machines
Cooking machines
Water heating machines
Note that the regulation doesn’t cover appliances designed to be used in
industrial premises.
Learn More
a. Official Text of the Regulation
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.
Product Examples
Here some examples of products regulated by the Pressure Equipment
Directive:
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Pressure vessels
Shell and water tube boilers
Process pipeworks
Relief valves
Learn More
a. Official Text of the Directive
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 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.
Learn More
a. Official Text of the Directive
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 Examples
The directive covers lifts permanently installed in buildings and construction
sites.
Annex II of the directive lists exempted products, such as:
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Construction site hoists
Cableways
Lifts for military or police purposes
Learn More
a. Official Text of the Directive
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 Examples
The regulation covers cableways designed to transport people, while it doesn’t
cover cableways designed to transport goods.
Learn More
a. Official Text of the Directive
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.
Product Examples
This directive covers product such as:
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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.
Learn More
a. Official Text of the Regulation
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.
Product Examples
Railway vehicles are the main subject of this directive.
Learn More
a. Official Text of the Directive
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 Examples
Here some examples of products covered by the directive, when used in an
environment subject to explosie hazards:
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Lighting
Enclosures
Industrial plugs
Cable accessories
Sockets
Conversely, here some examples of product that aren’t covered by the
directive:
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Medical devices used in the medical environment
Domestic-used equipment where the environment is generally
safe
Personal protective equipment covered by the PPE Regulation
Learn More
a. Official Text of the Directive
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 Examples
This Directive applies to most explosives for civil uses.
Learn More
a. Official Text of the Directive
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 Examples
This Directive applies to pyrotechnic articles designed for commercial use,
including:
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Fireworks
Stage pyro
Products that produce war-gaming battle effects
Seat-belt pre-tensioners