Which Products Require an EU Notified Body?

Certain products require the involvement of a notified body before they can be sold in the European Union. Whether that is the case depends on the applicable EU regulations and directives, and whether the product belongs to a certain category.

In this guide, we provide examples of product types that require the use of a notified body, while also explaining the basis.

Personal Protective Equipment (PPE)

According to the Personal Protective Equipment Regulation, PPE is defined as equipment that protects users against health and safety risks.

There are three risk categories of PPE, two of which require use of a notified body. The table below lists the risk categories, along with examples of products listed in the PPE Guidelines document, for each category. It also specifies whether you need a notified body for the risk category in question.

Product category	Product examples	Notified body required?
Category I	Non-corrective sunglasses Diving goggles and face masks with integrated snorkel Ski goggles Light headgear that protects the scalp Professional clothing to protect against the rain Sport shoes	No
Category II	Eye filters Head protection for sports against mechanical impact Face protection equipment (e.g. face shields) Diving and immersion suits Beekeeper garments Protective clothes for waterskiing	Yes
Category III	Hearing protection Equipment to protect against falls (e.g. climbing carabiners) Respiratory protective equipment Equipment to protect against electric shock Life jackets PPE designed to protect against high-pressure jets with a pressure of over 200 bars	Yes

Electronics

The following table lists directives and regulations that apply to electronics and their product scope. It also explains the circumstances under which a notified body is needed for each directive or regulation.

Regulation	Product scope	Notified body required?
RoHS Directive	Electrical and electronic equipment (EEE) in the categories listed in Annex I Examples: a. Washing machines b. Toasters c. Personal computers	No
Low Voltage Directive	Electrical equipment with a voltage range between 50-100V (AC) and 57-1500V (DC).	No
Radio Equipment Directive	Radio equipment.	Yes, but only if harmonised standards are not applied, or when they do not exist for your product.
EMC Directive	Apparatus or fixed installations Examples: a. Electronic taximeters d. Road traffic signal systems e. Arc welding equipment	Article 14 specifies that you can choose between using either: a. The conformity assessments in Annex III that require you to use a notified body, or b. The conformity assessment in Annex II that does not require you to use a notified body
Ecodesign for Sustainable Products Regulation	All physical products, except those listed in Article 1(2)	Article 4 of this regulation indicates that the EU Commission should adopt delegated acts to inform manufacturers which conformity assessments they can use. You may need to use a conformity assessment body for some of those assessments.
Cyber Resilience Act	Products with digital elements designed to connect to a device or network via data or physical means	Yes, when harmonised standards, common specifications or European cybersecurity certification schemes exist (but are not, or partially, applied) or do not exist.

Batteries

The table in this section lists types of batteries listed in the Batteries Regulation, and examples of such batteries. It also explains when you need a notified body for those products.

As we could not find examples of products in the regulation, we found some examples from both an EU briefing document and e-commerce websites.

Battery type	Product examples	Notified Body required?
Portable batteries	AA batteries Mobile phone batteries	No
Electric vehicle batteries	Lithium-ion batteries Lead-acid batteries	Yes, when the conditions set in Articles 7 and 8 apply
Rechargeable industrial batteries	Lithium-ion rechargeable batteries Nickel-cadmium batteries	Yes, when the conditions specified in Articles 7 and 8 apply
Light means of transport (LMT) batteries	Batteries for e-bikes Batteries for e-scooters	Yes, when the conditions specified in Articles 7 and 8 apply
Starting, lighting and ignition (SLI) batteries	Automotive batteries Marine and RV batteries	Yes, when the conditions in Article 8 apply

Toys

The Toy Safety Directive defines toys as products intended for play by children under 14 years. Whether you need a notified body depends on the existence and application of harmonised standards.

Situation	Notified body required?
Harmonised standards exist and are applied	No
Harmonised standards exist, but were not applied	Yes
Harmonised standards do not exist	Yes

Construction Products

A construction product is a product or set of products manufactured for use in building projects. The Construction Products Regulation features several systems of assessment and verification for constancy of performance (AVCP). Whether you require a notified body depends on which system of AVCP you use.

This section lists the different systems of AVCP and when a notified body is required. Note that the regulation lists four types of notified bodies in Annex V that perform the different systems of AVCP:

• “Notified product certification body”
• “Notified factory production control certification body”
• “Notified assessment validation body”
• “Notified laboratory”

The EU’s “Construction Products Regulation (CPR)” page lists six delegated decisions that specify which systems of AVCP apply to which construction products or families of construction products. The product examples listed in the table below come from those delegated decisions.

System of Assessment and Verification of Constancy of Performance	Product examples	Notified body required?
System 1+	Anchor devices	Yes – a notified product certification body
System 1	Manhole covers and gully tops	Yes – a notified product certification body
System 2+	Metal-faced sandwich panels for structural use Geosynthetics (membranes and textiles) used for drainage	Yes – a notified factory production control certification body
System 3	Ventilation ducts and pipes for air ventilation Septic tanks	Yes – a notified laboratory
System 3+	We could not find an example	Yes – a notified assessment validation body
System 4	Balustrade kits Railing kits	No

Medical Devices

The Medical Devices Regulation sets requirements for different types of medical devices. This section lists medical device classes and product examples. It also explains in which cases you need a notified body.

We found examples of products in the Guidance on classification of medical devices document published by the EU.

Medical device class	Product examples	Notified body required?
Class I	Adhesive bandages Examination gloves	Yes, but only for devices that: a. Are sterile, or b. Have a measuring function, or c. Are reusable surgical instruments
Class IIa	Short term corrective contact lenses Tracheal tubes	Yes
Class IIb	Long-term use urethral stents Long-term use urinary catheters	Yes
Class III	Neuro-endoscopes Spinal needles	Yes

Measuring Instruments

The Measuring Instruments Regulation sets requirements for different types of measuring instruments. You generally need a notified body to perform the conformity assessment on your product.

Instrument-specific Annex	Product scope	Notified body required?
Annex III	Water meters	Yes
Annex IV	Gas meters and volume conversion devices	Yes
Annex V	Active electrical energy meters	Yes
Annex VI	thermal energy meters	Yes
Annex VII	measuring systems for the continuous and dynamic measurement of quantities of liquids other than water	Yes
Annex VIII	Automatic weighing instruments	Yes
Annex IX	Taximeters	Yes
Annex X	Material measures	Yes
Annex XI	Dimensional measuring instruments	Yes
Annex XII	Exhaust gas analysers	Yes

Gas Appliances

The Gas Appliances Regulation covers appliances that burn gaseous fuels for purposes such as cooking and refrigeration. It also covers fittings, that is, safety devices designed for incorporation into an appliance.

Product type	Notified body required?
Appliances	Yes
Fittings	Yes

Other regulations that require a notified body

There are other directives and regulations that require you to use notified bodies for certain products and situations. The EU’s “Search by Legislation” page lists 34 directives and regulations for which you need to use a notified body.

Here are the directives and regulations from the list that are not mentioned in the previous sections of this guide:

• Noise Emission in the Environment Directive
• Transportable Pressure Equipment Directive
• Pyrotechnic Articles Directive
• Recreational Craft Directive
• Explosives for Civil Uses Directive
• Simple Pressure Vessels Directive
• Non-Automatic Weighing Instruments Directive
• Lifts Directive
• Equipment for Explosive Atmospheres (ATEX) Directive
• Pressure Equipment Directive
• Marine Equipment Directive
• Rail System Interoperability Directive
• Active Implantable Medical Devices Directive
• Hot Water Boilers Directive
• In-Vitro Diagnostic Medical Devices Regulation
• Cableway Installations Regulation
• EU Fertilising Products Regulation
• Unmanned Aircraft Systems Regulation
• Interoperability of Electronic Road Toll Systems Regulation
• Machinery Regulation

Note that additional regulations that require the use of a notified body, such as the Artificial Intelligence Act (Regulation (EU) 2024/1689), may exist.