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A CE mark indicates that a product is compliant with all applicable EU regulations and directives that mandate CE marking. Such EU directives and regulations apply to a wide range of products, including electronics, toys, helmets, sunglasses, and medical devices.
In this guide, we list 34 directives and regulations for which the CE marking is required. Each section includes product examples and requirements that EU importers and manufacturers must be aware of.
2026 Update: We added the following new EU regulations, which mandate CE marking:
- EU Cybersecurity Act
- Toy Safety Regulation
- Construction Product Regulation 2024
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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.
We could not find any Notified Body requirements in the Directive.
Product scope
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:
- Lamps
- Charging cables
- Electrical hair care appliances
- Electrical outdoor barbecue appliances
Annex II of the Directive includes a list of exempted products, such as household plugs and socket outlets.
Harmonised standards (examples)
EN 60335-2-2 Household and similar electrical appliances – Safety – Part 2-2: Particular requirements for vacuum cleaners and water-suction cleaning appliances
EN 60432-2 – Incandescent lamps – Safety specifications – Part 2: Tungsten halogen lamps for domestic and similar general lighting purposes
EN ISO 11252 – Lasers and Laser-related Equipment – Laser Device – Minimum Requirements for Documentation
EN ISO 60825-2 – Safety of laser products – Part 2: Safety of optical fibre communication systems (OFCS)
EN 60998-1 – Connecting devices for low-voltage circuits for household and similar purposes – Part 1: General requirements
Learn more
- Low Voltage Directive (LVD): An Essential Guide
- List of Products Covered by the Low Voltage 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 should still be able to operate as intended.
According to the product and installations, Notified Body involvement may be required. We suggest getting in touch with a reputable lab testing company to assess your specific case.
Product scope
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:
- Electronic taximeters
- Sewing machines
- Fire alarm systems
- Electrical lighting
Products classified as “inherently benign”, such as quartz watches, are exempted from the scope of the directive.
Harmonised standards (examples)
EN 1155 – Building hardware – Electrically powered hold-open devices for swing doors – Requirements and test methods
EN 55014-1 – Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 1: Emission
EN 60669-2-1 – Switches for household and similar fixed electrical installations – Part 2-1: Particular requirements – Electronic switches
Learn more
- Electromagnetic Compatibility (EMC) Directive: An Essential Guide
- List of Products Covered by the EMC Directive
Radio Equipment Directive (RED)
The Radio Equipment Directive establishes electrical safety, electromagnetic compatibility, radio spectrum use efficiency, and other requirements for radio equipment.
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 harmonised standards, then the conformity assessment procedure may be completed without Notified Body involvement.
However, if the manufacturer or importer has not applied harmonised standards – or such standards do not exist for the product – then a Notified Body is required, either via EU-type examination or conformity based on full quality assurance.
Product scope
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:
- Wireless microphones
- Laptops
- Smartwatches
- Routers
- Devices with WiFi capabilities
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)
EN 303 354 V1.1.1 – Amplifiers and Active Antennas for TV Broadcast Reception in Domestic Premises; Harmonised Standard Covering the Essential Requirements
EN 302 077 V2.3.1 – Transmitting equipment for the Digital Audio Broadcasting (DAB) service; Harmonised Standard for access to radio spectrum
EN 300 433 V2.1.1 – Citizens’ Band (CB) radio equipment; Harmonised Standard covering the essential requirements of Article 3(2) of the Directive 2014/53/EU
Learn more
- Radio Equipment Directive (RED): An Essential Guide
- List of Products Covered by the Radio Equipment Directive (RED)
RoHS Directive
The RoHS Directive restricts the use of hazardous substances in electrical and electronic equipment (EEE) to protect human health and avoid environmental pollution.
More specifically, the RoHS Directive restricts the use of the following substances:
- 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
Categories of EEE covered by this Directive
1. Large household appliances.
2. Small household appliances.
3. IT and telecommunications equipment.
4. Consumer equipment.
5. Lighting equipment.
6. Electrical and electronic tools.
7. Toys, leisure and sports equipment.
8. Medical devices.
9. Monitoring and control instruments including industrial monitoring and control instruments.
10. Automatic dispensers.
11. 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
- Automatic dispensers
- Lighting products
- Household appliances
- Electrical medical devices
Harmonised standards (examples)
EN IEC 63000 – Technical Documentation for the Assessment of Electrical and Electronic Products with Respect to the Restriction of Hazardous Substances
Learn more
- EU Restriction of Hazardous Substances Directive (RoHS): An Essential Guide
- List of Products Covered by RoHS
Batteries and Batteries Waste Regulation
The Batteries Regulation establishes safety and sustainability requirements for batteries and waste batteries sold in the EU. Specifically, it sets requirements such as the following:
- Substance restrictions
- Extended producer responsibility (EPR) requirements
- Digital battery passport
Note that the requirements vary according to the type of battery. This includes the involvement of a Notified Body, which is only required for some types of batteries.
Product scope
This Regulation applies to all categories of batteries, namely portable batteries, starting, lighting and ignition batteries (SLI batteries), light means of transport batteries (LMT batteries), electric vehicle batteries and industrial batteries, regardless of their shape, volume, weight, design, material composition, chemistry, use or purpose. It shall also apply to batteries that are incorporated into or added to products or that are specifically designed to be incorporated into or added to products.
Product examples
- Portable batteries
- Starting, lighting and ignition batteries (SLI batteries)
- Light means of transport batteries (LMT batteries)
- Electric vehicle batteries
- Industrial batteries
Harmonised standards (examples)
The following standards are currently under draft:
prEN 18060 – Road vehicles – Rechargeable batteries with internal energy storage – Performance of alkali-Ion (Li-Ion, Na-Ion), Pb, NiMH and combined chemistries EV modules and batteries
prEN 18061 – Road vehicles — Electrically propelled vehicles — Steps, conditions and protocols for the safe repair and re-use of modules and batteries originally designed for EV applications
prEN IEC 60086-1 – Primary batteries – Part 1: General
prEN IEC 60086-2-1 – Primary batteries – Part 2-1: Physical and electrical specifications of batteries with aqueous electrolyte
Learn more
Ecodesign
The Ecodesign for Sustainable Products Regulation sets a framework for ecodesign requirements of consumer products sold in the EU.
Specifically, it sets requirements concerning a digital passport for your product, the destruction of certain unsold consumer products, and others. Additionally, you will have to comply with requirements set by specific delegated acts, which will be different according to the product category.
A Notified Body may also be required, according to the provisions set in the delegated acts.
Ecodesign for Sustainable Products Regulation (ESPR)
Introduction / explain what the regulation or directive covers and its purpose (no update unless necessary)
Product scope
This Regulation applies to any physical goods that are placed on the market or put into service, including components and intermediate products.
Product examples
Here are several examples of products covered by the Ecodesign for Sustainable Products Regulation:
- Apparel
- Footwear
- Furniture
- Electronic appliances
Harmonised standards (examples)
According to the regulation, delegated acts should specify harmonised standards for the different product categories. At the moment of writing this guide, we could not find any harmonised standards.
Learn more
Ecodesign for Sustainable Products Regulation: An Overview
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 may have a big impact on energy consumption.
The directive mainly sets requirements on the energy efficiency of household appliances and other products, with the goal of protecting the environment.
Besides the Directive, there are specific implementing measures that detail the energy efficiency requirements for different groups of products that fall into the scope of the Directive.
Product scope
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:
- Light sources
- Ovens
- Dishwashers
- Heaters
- Fans
- Fridges
Harmonised standards (examples)
EN 60436 – Electric dishwashers for household use – Methods for measuring the performance
EN 30-2-1 – Domestic cooking appliances burning gas – Part 2-1: Rational use of energy – General
EN 14511-2 – Air conditioners, liquid chilling packages and heat pumps with electrically driven compressors for space heating and cooling – Part 2: Test conditions
EN 62552 – Household refrigerating appliances – Characteristics and test methods
Learn more
Software / IT
Artificial Intelligence Regulation
The Artificial Intelligence Regulation establishes rules for selling, employing, and using artificial intelligence systems in the EU. As well as banning specific AI practices, the regulation also sets requirements such as:
- Requirements for high-risk artificial intelligence systems and their operators
- Transparency rules for specific AI systems
- Rules for selling general-purpose AI models
A conformity assessment procedure is required for high-risk artificial intelligence systems, which are defined in Article 6. This includes, for example, AI systems that are used as safety components in products. A Notified Body may be required in some cases.
Product scope
This Regulation applies to:
(a) providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models in the Union, irrespective of whether those providers are established or located within the Union or in a third country;
(b) deployers of AI systems that have their place of establishment or are located within the Union;
(c) providers and deployers of AI systems that have their place of establishment or are located in a third country, where the output produced by the AI system is used in the Union;
(d) importers and distributors of AI systems;
(e) product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark;
(f) authorised representatives of providers, which are not established in the Union;
(g) affected persons that are located in the Union.
The definition of AI systems is provided in Article 3 of the regulation.
Product examples
Here we list some examples of covered AI systems:
- Biometric identification systems
- Critical infrastructure systems
- Educational and vocational training systems
- Employment, worker management, and self-employment access systems
- Private and public services access systems
- Law enforcement systems
- Asylum, border control management, and migration systems
The regulation sets several exemptions. For example, it does not apply to AI systems or AI models that are:
- Used exclusively for military or national security purposes
- Developed for scientific research, testing, and development
- Used for non-professional activity
Learn more
AI Act (Artificial Intelligence Regulation (EU) 2024/1689): An Overview
EU Cybersecurity Act
This Act aims to ensure that digital products that are connected to a network, such as baby monitors or modems, are protected against cyber threats.
The manufacturer should demonstrate that the covered products comply with the essential cybersecurity requirements set out by the Act using one of the conformity assessment procedures listed in Article 32. A Notified Body is required for some of these procedures.
Product scope
This Regulation applies to products with digital elements made available on the market, the intended purpose or reasonably foreseeable use of which includes a direct or indirect logical or physical data connection to a device or network.
Product examples
Here we list some product examples taken from the regulation:
- Baby monitoring systems
- Physical and virtual network interfaces
- Routers
- Modems
- Switches
- Smart home general-purpose virtual assistants
- Password managers
Learn more
EU Cyber Resilience Act: An Essential Guide
Machinery
Machinery Regulation
The Machinery Regulation establishes health and safety requirements for completed and partially completed machinery.
The regulation only allows the sale of machinery products that comply with the safety and health requirements in Annex III and that are correctly installed, maintained, and used as intended.
A Notified Body is required for many of the products covered by the regulation. However, for products listed in Annex I, Part B, you can apply the Internal production control conformity assessment if the product complies with relevant standards and requirements. This means that, in this case, you would not need a Notified Body.
Product scope
This Regulation applies to machinery and the following related products:
(a) interchangeable equipment;
(b) safety components;
(c) lifting accessories;
(d) chains, ropes and webbing;
(e) removable mechanical transmission devices.
This Regulation also applies to partly completed machinery.
Product examples
The regulation covers machinery and related products, such as:
- Hand-held drain cleaners
- Transportable table saws
- Electrically-powered lawn mowers
- Steam cleaners
Harmonised standards (examples)
EN ISO 12100 – Safety of machinery – General principles for design – Risk assessment and risk reduction
EN 1837 – Safety of machinery – Integral lighting of machines
EN ISO 13849-1 – Safety of machinery – Safety-related parts of control systems – Part 1: General principles for design
EN 1870-6 – Safety of woodworking machines – Circular sawing machines – Part 6: Circular sawing machines for fire wood
Learn more
Machinery Regulation: An Essential Guide
List of Products covered by the Machinery Regulation
Machinery Directive
The Machinery Directive will be replaced by the Machinery Regulation in January 2027. According to Article 52 of the Regulation, EC type-examination certificates and approval decisions issued under the Directive should remain valid until they expire.
As for the Regulation, the Machinery Directive also establishes safety requirements for completed and partially completed machinery.
Product scope
This Directive applies to the following products:
(a) machinery;
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) chains, ropes and webbing;
(f) removable mechanical transmission devices;
(g) partly completed machinery.
Product examples
- Power tools
- Food processing machinery
- Service robots
Harmonised standards (examples)
EN ISO 13482 – Robotics – Safety requiremernts for service robots
EN 1678 – Food processing machinery – Vegetable cutting machines – Safety and hygiene requirements
EN ISO 11148-10 – Hand-held non-electric power tools – Safety requirements – Part 10: Compression power tools
Learn more
Machinery Directive: An Essential Guide for EU Importers
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.
The directive provides two options for the conformity assessment procedure of the regulated outdoor machinery. When such equipment is subject to permissible sound power levels, the Notified Body’s involvement is required.
When the equipment is only subject to noise marking, manufacturers should apply the internal control of the production procedure, which does not require the involvement of a Notified Body.
Product scope
This Directive applies to equipment for use outdoors listed in Articles 12 and 13 and defined in Annex I.
Product examples
There are many types of equipment covered by the directive, mainly used on construction sites, parks, gardens, and landfills. Here are some examples:
- Dozers
- Dumpers
- Excavators
- Lawn trimmers
- Power generators
Note that the directive does not cover equipment used as a means of transport of goods or passengers or for military purposes.
Toys
Toy 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 chemical and heavy metals concentration limit, 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 may require Notified Body involvement, including when:
- No harmonised standards for the product exist
- Harmonised standards exist, but the manufacturer or importer did not apply them
- The manufacturer or importer deems the use of a Notified Body necessary
Product scope
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:
- Foam floor puzzles
- Stuffed toys
- Height gauges shaped like soft toys
- Electrical toys
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)
EN 71-1 – Safety of toys – Part 1: Mechanical and physical properties
EN 71-2 – Safety of toys – Part 2: Flammability
EN 71-3 – Safety of toys – Part 3: Specification for migration of certain elements
EN 71-4 – Safety of toys – Part 4: Experimental sets for chemistry and related activities
EN 71-5 – Safety of toys – Part 5: Chemical toys (sets) other than experimental sets
EN 62115 – Electric Toys – Safety
Learn more
- Toy Safety Directive: An Essential Guide for Importers and Manufacturers
- List of Products Covered by the Toy Safety Directive and EN 71
Toy Safety Regulation
The Toy Safety Regulation will replace the Toy Safety Directive in 2030. As such, its objective is to ensure that toys are safe for children up to 14 years of age.
Note that, in the following cases, the involvement of a Notified Body is required in order to comply with some of the requirements of the regulation:
- When relevant harmonised standards do not exist
- When harmonised standards exist but are not applied
- When relevant harmonised standards are published with a restriction that applies to the toy in question
- When the manufacturer deems that third-party verification is required
The regulation also sets requirements for a digital passport.
Product scope
This Regulation applies to products that are designed or intended, whether or not exclusively, for use in play by children under 14 years of age (toys).
Product examples
Here we list some examples of products that are under the scope of the Regulation:
- Aquatic toys
- Functional toys
- Activity toys
- Gustative games
Note that Annex I lists products that are excluded from the scope of the Regulation, such as playground equipment intended for public use and toy steam engines.
Harmonised standards
At the moment of updating this guide, we could only find harmonised standards for the Toy Safety Directive (e.g. EN 71 standards). This is probably due to the fact that the Toy Safety Regulation will only apply from 2030.
While the current standards harmonised under the Toy Safety Directive may still apply, at the moment, we cannot be certain.
Learn more
EU Toy Safety Regulation: An Essential Guide
Personal Protective Equipment (PPE) Regulation
The Personal Protective Equipment (PPE) Regulation establishes design and manufacturing requirements for personal protective equipment sold in the EU 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 in the environment associated with its 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
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 minimal risks such as:
- Superficial mechanical injury
- Contact with cleaning materials of weak action
- Contact with hot surfaces not exceeding 50 °C
Examples of Category I PPE include:
- Sunglasses
- Gardening gloves
- Cut-resistant gloves
- Face masks
- Ski goggles
Category II
Category II PPE is designed to protect the users from risks that are not listed under Category I or III. Examples of Category II PPE include:
- Bicycle helmets
- Protective footwear
- Reflective clothing
- 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-defence, and resistance to non-extreme climate conditions is often exempted from the PPE Regulation, although there are some exceptions.
Harmonised standards (examples)
EN 136 – Respiratory Protective Devices – Full Face Masks – Requirements, Testing, Marking
EN 142 – Respiratory Protective Devices – Mouthpiece Assemblies – Requirements, Testing, Marking
EN 352 – Hearing Protectors: General Requirements – Part 1: Ear- Muffs
EN 342 – Protective Clothing: Ensembles and Garments for Protection against Cold
EN 397 – Industrial safety helmets
Learn more
- Personal Protective Equipment (PPE) Regulation: An Essential Guide
- List of Products Covered by the PPE Regulation
Construction Products
Construction Product Regulation 2011
The Construction Products Regulation provides a regulatory framework to assess the performance of construction products from the perspective of mechanical resistance, stability, health, environmental impact, and more.
The CE marking is only required for products that are covered by harmonised standards. For products that are not fully covered by harmonised standards, you can request a European Technical Assessment (ETA) from a Technical Assessment Body (TAB) if you want to affix the CE marking to your product.
In both cases, you will then need an assessment and verification of consistency of performance (AVCP), which generally requires the involvement of a Notified Body.
Product scope
‘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:
- Doors
- Windows
- Gates
- Floorings
- Roof lights
Harmonised standards (examples)
EN 490 – Concrete Roofing Tiles and Fittings for Roof Covering and Wall Cladding – Product Specifications
EN 517 – Prefabricated Accessories for Roofing – Roof Safety Hooks
EN 1036 – Glass in Building – Mirrors from Silver-coated Float Glass for Internal Use – Part 2: Evaluation of Conformity; Product Standard
Construction Product Regulation 2024
The Construction Product Regulation 2024 (CPR 2024) replaces the Construction Product Regulation 2011 (CPR 2011) as of January 2026. Its goal is to set performance and safety requirements for construction products.
However, as far as we understand it, the requirements of the CPR 2011 should still apply to construction products that are subject to harmonised standards under the CPR 2011, and for which there are no standards harmonised under the CPR 2024. You can find more information in Article 95 of the CPR 2024.
In general, the CE marking is required if a harmonised standard applies to the product, or if the manufacturer requires a European Technical Assessment (ETA). In this case, an assessment and verification system (AVS) and a digital product passport are also required. Note that some types of AVS also require the involvement of a Notified Body.
Product scope
This Regulation applies to construction products, including used products, and to the following items:
(a) key parts of products; and
(b) parts or materials intended to be used for products covered by this Regulation, if the manufacturer of those parts or materials so requests.
Product examples
Here are some examples of covered products:
- Floorings
- Construction adhesives
- Windows
- Sanitary appliances
Harmonised standards
At the moment of updating this guide, we could not find any harmonised standards under the CPR 2024.
Learn more
- Construction Products Regulation (CPR) 2024: An Essential Guide
- List of Products Covered by the EU Construction Products 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 patients and users.
Product scope
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 for the highest risk. Products such as cardiovascular catheters, aneurysm clips, hip-joint implants, and prosthetic heart valves are considered 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, and
- Are not reusable surgical instruments
Product examples
Here is a short list 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 and pregnancy test strips, are excluded, as they are covered by a specific regulation.
Harmonised standards (examples)
EN IEC 60601-2-83 – Medical Electrical Equipment – Part 2-83: Particular Requirements for the Basic Safety and Essential Performance of Home Light Therapy Equipment
EN ISO 17664-1 – 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
- Medical Devices Regulation: An Essential Guide
- Products covered by the Medical Devices Regulation: An Overview
In-Vitro Diagnostic Medical Devices Regulation
The In-Vitro Diagnostic Medical Devices Regulation establishes rules for selling or utilising human-use in vitro diagnostic medical devices and associated accessories.
Product scope
This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union.
Medical Devices Classes
The regulation divides in-vitro diagnostic medical devices into four classes – Classes A, B, C, and D, where class D medical devices are of the highest risk.
Class A: These are low-risk in-vitro diagnostic medical devices, such as those used for general laboratory diagnostic purposes, or specimen receptacles.
Class B: These are moderate-risk in-vitro diagnostic medical devices that do not belong to any other class, such as devices for detecting glucose.
Class C: These are high-risk in-vitro diagnostic medical devices, mainly meant for self-testing purposes. They include human genetic testing devices, blood grouping devices, and cancer staging devices.
Class D: These are the highest-risk in-vitro diagnostic medical devices that are used, for example, to detect transmissible agents and determine the infectious load of a fatal disease.
A Notified Body is generally required.
Product examples
- Nucleic acid quantitation kits
- FSH device for fertility testing in blood
- Devices intended for detecting HPV
- Devices intended for blood grouping
Harmonised standards (examples)
EN ISO 11135 – Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 13408-1 – Aseptic processing of health care products – Part 1: General requirements
EN ISO 15223-1 – Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
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
Measurement Instruments
Measuring Instruments Directive
The Measuring Instruments Directive regulates measuring instruments sold in the EU. In particular, according to the directive, measuring instruments should provide an accurate measurement.
Note that, according to the product, Notified Body involvement may be required.
Product scope
This Directive applies to the measuring instruments defined in the instrument-specific Annexes III to XII
You can find the full list in the text of the Directive.
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)
EN 1359 – Gas Meters – Diaphragm Gas Meters
EN 12405-1 – Gas meters – Conversion devices – Part 1: Volume conversion
EN 12261 – Gas Meters – Turbine Gas Meters
EN 14236 – Ultrasonic Domestic Gas Meters
Non-Automatic Weighing Instruments Directive
The Non-Automatic Weighing Instruments Directive sets down the regulatory requirements, specifications, and standards for weighing equipment.
It stipulates that it is compulsory to conduct a product performance assessment and ensure the products meet all essential requirements before being sold in the EU. Notified Body involvement is generally required.
Product scope
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
Harmonised standards (examples)
EN 45501 – Metrological Aspects of Non-Automatic Weighing Instruments
Gas and Pressure Equipment
Gas Appliances Regulation
The Gas Appliances Regulation covers a wide range of appliances that function by means of burning gaseous fuels for the purpose of cooking, heating, refrigerating, lighting, and washing. The regulation establishes procedures from the aspects of design, structure, and safety.
Conformity with the Gas Appliances Regulation requires Notified Body involvement.
Product scope
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 does not cover appliances designed to be used in industrial premises.
Harmonised standards (examples)
EN 30-1-1 – Domestic Cooking Appliances Burning Gas – Part 1-1: Safety – General
EN 30-1-2 – Domestic cooking appliances burning gas – Part 1-2: Safety – Appliances having forced-convection ovens
EN 203-1 – Gas Heated Catering Equipment – Part 1: General Safety Rules
EN 15502-1 – Gas-fired heating boilers – Part 1: General requirements and tests
Pressure Equipment Directive
The Pressure Equipment Directive regulates pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar 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 unless the product is classified under category I.
Product scope
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
- Piping
- Pressure accessories
Harmonised standards (examples)
EN 334 – Gas Pressure Regulators for Inlet Pressures Up to 100 Bar
EN 12178 – Refrigerating systems and heat pumps – Liquid level indicating devices – Requirements, testing and marking
EN 12778 – Cookware – Pressure cookers for domestic use
Simple Pressure Vessels Directive
The Simple Pressure Vessels Directive establishes procedures for simple pressure vessels in terms of design, manufacturing, safety, and other essential requirements.
Generally speaking, the directive requires Notified Body involvement.
Product scope
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 for 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 that are not intended to be fired.
Harmonised standards (examples)
EN ISO 9606 – Qualification testing of welders – Fusion welding – Part 1: Steels
EN 10207 – Steels for simple pressure vessels – Technical delivery requirements for plates, strips and bars
Transportation
Lifts Directive
The Lifts Directive regulates lifts in terms of design, manufacture, installation, safety rules, and more. In particular, the essential requirements listed in Annex I should be followed.
This Directive generally requires Notified Body involvement.
Product scope
1. This 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.
The directive also applies to safety components.
Product examples
The directive covers lifts permanently installed in buildings and construction sites.
Article 1 lists exempted products, such as:
- Construction site hoists
- Cableways
- Lifts for military or police purposes
Harmonised standards (examples)
EN 81-20 – Safety Rules for the Construction and Installation of Lifts – Lifts for the Transport of Persons and Goods – Part 20: Passenger and Goods Passenger Lifts
EN 81-73 – Safety rules for the construction and installation of lifts – Particular applications for passenger and goods passenger lifts – Part 73: Behaviour of lifts in the event of fire
EN 12016 – Electromagnetic Compatibility – Product Family Standard for Lifts, Escalators and Moving Walks – Immunity
EN 13015 – Maintenance for lifts and escalators – Rules for maintenance instructions
Cableway Installations Regulation
The Cableway Installations Regulation sets up rules for cableways designed for the purpose of transporting people. This regulation involves requirements for the design, construction, safety analysis, and more.
Note that the conformity assessment procedures specified by this Regulation require Notified Body involvement.
Product scope
This Regulation applies to new cableway installations designed to transport persons, to modifications of cableway installations requiring a new authorisation, and to subsystems and safety components for cableway installations.
Product examples
The regulation covers cableways designed to transport people, while it does not cover cableways designed to transport goods.
Harmonised standards (examples)
EN 1709 – Safety Requirements for Cableway Installations Designed to Carry Persons – Precommissioning Inspection, Maintenance, Operational Inspection and Checks
EN 1908 – Safety Requirements of Cableway Installations Designed to Carry Persons – Tensioning Devices
EN 1909 – Safety Requirements for Cableway Installations Designed to Carry Persons – Recovery and Evacuation
EN 13796-2 – Safety requirements for cableway installations designed to carry persons – Carriers – Part 2: Slipping resistance tests for grips
Recreational Craft Directive
The Recreational Craft Directive sets out requirements for the design, manufacture, and safety of recreational crafts and the components of these products.
Excluding some types of crafts with a hull length shorter than 12 meters, Notified Body involvement is generally required for compliance.
Product scope
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 directive.
Product examples
This directive covers products such as:
- Personal watercraft powered by engines
- Craft propulsion engines
Crafts that are propelled solely by human power, such as canoes, kayaks, and surfboards, are excluded.
Harmonised standards (examples)
EN ISO 7840 – Small craft – Fire-resistant fuel hoses
EN ISO 9094 – Small craft – Fire protection
EN ISO 10087 – Small craft – Craft identification – Coding system
EN ISO 10088 – Small craft – Permanently installed fuel systems
EN ISO 16180 – Small craft – Navigation lights – Installation, placement and visibility
Learn more
Recreational Craft Directive: Guide for EU Importers and Manufacturers
Rail System Interoperability Directive
The Rail System Interoperability Directive sets requirements concerning the design, construction, placement in service, and more for rail systems. Its main goal is to achieve overall compatibility of the EU rail system.
This directive requires the involvement of a Notified Body.
Product scope
This Directive lays down the provisions relating to, for each subsystem, the interoperability constituents, the interfaces and procedures, and the conditions of overall compatibility of the Union rail system required in order to achieve its interoperability.
Product examples
This directive covers rail systems. It does not cover metros, trams, and networks that are separate from the rest of the EU.
Harmonised standards (examples)
EN 12663-2 – Railway applications – Structural requirements of railway vehicle bodies – Part 2: Freight wagons
EN 13232-3 – Railway applications – Track – Switches and crossings – Part 3: Requirements for wheel/rail interaction
EN 61375-2-1 – Electronic railway equipment – Train communication network (TCN) – Part 2-1: Wire Train Bus (WTB)
EN 62621 – Railway applications – Fixed installations – Electric traction – Specific requirements for composite insulators used for overhead contact line systems
Explosives
Equipment for Explosive Atmospheres (ATEX) Directive
The ATEX Directive defines the essential health and safety requirements 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
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 full scope
Product examples
Here are some examples of products covered by the directive, when used in an environment subject to explosive hazards:
- Fans
- Vacuum cleaners
- Electrostatic hand-held spraying equipment
Conversely, here are some examples of products that are not covered by the directive:
- Medical devices used in the medical environment
- Domestic-use equipment where the environment is generally safe
- Personal protective equipment covered by the PPE Regulation
Harmonised standards (examples)
EN 1127-1 – Explosive atmospheres – Explosion prevention and protection – Part 1: Basic concepts and methodology
EN 14986 – Design of fans working in potentially explosive atmospheres
EN 1755 – Industrial Trucks – Safety Requirements and Verification – Supplementary Requirements for Operation in Potentially Explosive Atmospheres
EN 17348 – Requirements for design and testing of vacuum cleaners for use in potentially explosive atmospheres
Explosive for Civil Use Directive
The Explosive for Civil Use Directive regulates the design, manufacturing and supply of civil explosive products to protect humans and properties. It requires Notified Body involvement.
Product scope
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.
Harmonised standards (examples)
EN 13630-1 – Explosives for civil uses – Detonating cords and safety fuses – Part 1: Requirements
EN 13631-2 – Explosives for civil uses – High explosives – Part 2: Determination of thermal stability of explosives
EN 13763-3 – Explosives for civil uses – Detonators and relays – Part 3: Determination of sensitiveness to impact
EN 13938-1 – Explosives for civil uses – Propellants and rocket propellants – Part 1: Requirements
Pyrotechnic Articles Directive
This directive sets up safety rules and market circulation rules for pyrotechnic articles in the EU. It requires the involvement of a Notified Body.
Product scope
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
- Pyrotechnic articles for vehicles
Harmonised standards (examples)
EN ISO 14451-8 – Pyrotechnic articles – Pyrotechnic articles for vehicles – Part 8: Requirements and categorization for igniters (ISO 14451-8:2013)
EN 15947-4 – Pyrotechnic articles – Fireworks, Categories F1, F2 and F3 – Part 4: Test methods
EN 16256-3 – Pyrotechnic articles – Theatrical pyrotechnic articles – Part 3: Requirements for construction and performance
EN 16261-3 – Pyrotechnic articles – Fireworks, Category 4 – Part 3: Test methods
Unmanned Aircraft Systems Regulation
The Unmanned Aircraft Systems Regulation establishes design and safety requirements for unmanned aircraft systems (UAS). This includes requirements concerning:
- Maximum take-off mass
- Maximum speed
- Maximum attainable height
- Stability
UAS covered by Chapter II requires a Notified Body assessment. Conversely, products covered by Chapter III must undergo certification issued by the competent authority, as explained in Regulation (EU) 2019/947.
Product scope
1. Chapter II of this Regulation applies to the following products:
(a) UAS intended to be operated under the rules and conditions applicable to the ‘open’ category of UAS operations or to operational declarations under the ‘specific’ category of UAS operations pursuant to Regulation (EU) 2019/947, except privately built UAS, and bearing a class identification label as set out in Parts 1 to 5, 16 and 17 of the Annex to this Regulation indicating to which of the seven UAS classes referred to in Implementing Regulation (EU) 2019/947 it belongs;
(b) class C5 accessories kits as set out in Part 16;
(c) remote identification add-ons as set out in Part 6 of the Annex to this Regulation.
Chapter III of this Regulation applies to UAS operated under the rules and conditions applicable to the ‘certified’ and ‘specific’ categories of UAS operations pursuant to Implementing Regulation (EU) 2019/947 except when conducted under a declaration.
Product examples
We list here several examples of products covered by the regulation:
- UAS designed for transporting dangerous goods
- UAS designed for transporting people
- UAS designed for flying over crowds
Harmonised standards (examples)
We could only find one standard currently harmonised under the Unmanned Aircraft Systems Regulation:
EN 4709-002 – Aerospace series – Unmanned Aircraft Systems – Part 002: Direct Remote identification
CENELEC also lists several standards that are under approval.
Hot Water Boilers Directive
The Hot Water Boilers Directive sets out ecodesign requirements as well as energy efficiency requirements for hot-water boilers.
Generally speaking, this directive requires the involvement of a Notified Body.
Product scope
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 from the directive:
- Hot water boilers are capable of being fired by multiple fuels
- Some appliances with rated outputs of less than 6 kW
Fertilising Products Regulation
The Fertilising Products Regulation sets requirements for fertilising products (e.g., active substance content). In general, these products should not pose risks to the health of animals, humans, plants, or the environment.
The regulation generally requires manufacturers to employ the services of a Notified Body for fertilisers that contain certain component materials.
Product scope
Article 1
This Regulation applies to EU fertilising products.
Article 2
‘fertilising product’ means a substance, mixture, micro- organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, either on its own or mixed with another material, for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency
The regulation does not apply to animal by-products and plant protection products.
Product examples
This regulation covers EU fertilising products such as:
- Fertilisers
- Liming material
- Soil improvers
Harmonised standards (examples)
EN 17816 – Liming materials – Determination of physical and chemical properties and specific contaminants
EN 17817 – Fertilizers, liming materials and inhibitors. Determination of the quantity (declared by mass or volume)
EN 12580 – Soil improvers and growing media – Determination of a quantity
EN 15560 – Inorganic fertilizers – Determination of total nitrogen in calcium cyanamide nitrate free
EN 12946 – Liming materials – Determination of the calcium content and magnesium content – Complexometric method
FAQ
How do I know which CE marking regulations and directives apply?
This largely depends on the scope of the regulation or directive. For example, the Toy Safety Directive covers products with play value for children between the ages of 0 and 14.
If your product is a product with play value and intended for that age group, then your product is covered by the Toy Safety Directive.
The same logic applies to all other CE marking regulations and directives.
What are CE marking directives and regulations?
CE marking directives and regulations set safety and performance requirements that must be met by the manufacturer. These, in turn, mandate that the CE mark be affixed on the product or its packaging once certain requirements have been fulfilled.
For example, the Toy Safety Directive applies to toys sold in the EU. The CE mark is used to indicate that a particular toy is compliant with the Toy Safety Directive, and any other CE marking regulation or directive as well.
What are the requirements for CE marking directives and regulations?
CE marking regulations and directives generally set the following requirements for manufacturers:
- Ensure compliance with relevant standards
- Arrange testing to verify compliance
- Follow the relevant conformity assessment procedure
- Create a Declaration of Conformity
- Create technical documentation
- Create user instructions
- Affix product and packaging labelling
- Affix CE mark
- Certification by a Notified Body (if applicable)
Note that CE marking regulations and directives also set requirements for importers, distributors, and other economic operators. That being said, their responsibility is primarily focused on verifying that the manufacturer has complied with the applicable CE marking regulations and directives.
What CE Directive or Regulation applies to sea vessel/ship devices that secure equipment in place? I know Marine Directive does not apply. Machinery Directive expires Jan 2027 and replacement Machinery Regulation scope does not cover sea vessel equipment. Is there suitable Directive or Regulation?
Hi
What directive is applicable to a laser range finder working from 28V DC?
Thanks
Hello –
Thanks for the detailed explanation.
is it mandatory to get CE certificate when selling sunglasses in EU? Asking this because there are many sellers in amazon.co.uk/amazon.de selling sunglasses without any certification? is
there any control at the customs?
Thanks
Hello Serhan,
1. Sunglasses are covered by the PPE regulation, which also requires CE marking. There is a lot to it though than only certification.
2. Yes, there are controls at the customs, and after that too.
3. How do you know that those sellers are not compliant?