Notified Bodies in the European Union: A Complete Guide

The role of a Notified Body is to assess if a product is technically safe and compliant, correctly documented, and (in some cases) manufactured under the right conditions. In a way, the Notified Body act as a gatekeeper to the EU market – for more ‘high-risk’ and ‘sensitive’ products that cannot be ‘self-certified’.

That said, Notified Bodies are not government organizations. Instead, companies like Intertek and TUV are appointed to act as Notified Bodies for certain product categories.

In this guide, we explain what importers, exporters, and manufacturers must know about Notified Bodies and how they operate.

What is a Notified Body?

A Notified Body is an independent organization designated by an EU country to perform a set of assessments on products that are regulated by certain CE Marking directives or regulations. The conformity assessment might involve the following aspects:

a. Examines the technical design and conduct testing of the product in accordance with the technical requirements of the relevant directives or regulations

b. Review the relevant technical documentation, including the technical file, the user manual, and test reports

c. Audit the manufacturer’s quality management system

d. Perform product checks at random intervals

e. Draw up evaluation reports

f. Issue the EU-type examination certificate

The European Commission published a list of recognized notified bodies that perform assessment tests on products like toys, electronics, medical devices, and more.

The Commission assigns a 4-digit code to each Notified Body, with the purpose of uniquely identifying each company that acts as a Notified Body. The codes range from 0001-2900, and they must be placed below the CE Marking on the product and/or its packaging, and on the user manual.

Notified Bodies are designated for specific Directives and Regulations. Some of them only specialize in a single class of products and regulations, such as medical devices, while other companies are designated as Notified Body for several classes of products and regulations.

Lab Testing

Some Notified Bodies may also have the ability to perform the necessary product lab testing, and issue the related test reports.

However, not every Notified Body has the ability or proper facilities to carry out lab tests on behalf of manufacturers and importers. Notified Body that has the ability to perform on-site lab tests include:

• SGS
• TÜV SÜD
• BSI

Note that, although it’s possible to delegate testing to your Notified Body, there is no such obligation, as the Notified Body might also accept test reports from third-party lab testing companies.

Document Review

Notified Body shall also review the relevant technical documentation provided by the manufacturer or importer to demonstrate the safety and performance claims for the product. This might include:

• Technical file review
• User manual review
• Test reports review

On-Site Factory Visits

The conformity assessment procedure might also include, in some cases, factory visits at random intervals in order to supervise and evaluate the proper functioning of factory facilities. The visiting staff from the Notified Body may also carry lab tests in accordance with the requirements of specific directives and issue evaluation reports enclosed with test reports.

Other inspection activities might include the auditing of the manufacturer’s quality management system.

EC-type Examination Certificate

An EC-type examination certificate is issued by the Notified Body to confirm the compliance of a certain product with specific technical requirements or performance.

Under the current system, an EC-type examination certificate issued by a Notified Body is generally valid for three years. For products that bear higher potential risks to the users, the validity period may be shorter.

Which products require Notified Body Services?

Generally speaking, a Notified Body assessment is usually required for products that need higher and stricter safety standards, or that weren’t build according to harmonized EN standards. Here we list some categories of product that might require a Notified Body conformity assessment:

• Toys
• Electronica and electronic equipment
• Personal protective equipment
• Machinery
• Medical devices
• In Vitro diagnostic medical devices
• Measuring instruments
• Gas appliances
• Pressure equipment
• Lifts
• Hot water boilers
• Recreational crafts
• Explosives

What regulations or directives require Notified Body Services?

Most of the ‘CE Marking Directive and Regulations’ might require a Notified Body conformity assessment, even though not for all products that are under the scope of the directive. In this section, we introduce several directives that require the involvement of the notified body.

Radio Equipment Directive (RED)

The Radio Equipment Directive, which regulates most radio equipment devices placed in the market, requires the involvement of a Notified Body only if the manufacturer or importer didn’t follow the relevant harmonized standards, or such standards do not exist.

Here some examples of products that might require Notified Body assessment:

• Handheld radios
• Baby monitors
• Walkie talkies
• Smartphones
• Bluetooth enabled devices

Electromagnetic Compatibility (EMC) Directive

The Electromagnetic Compatibility (EMC) Directive sets limits to the electromagnetic emissions caused by electrical or electronic equipment so that such products do not interfere with the normal operation of radio, telecommunication, and other electrical or electronic products.

Depending on the specification of each type of electronic products, a Notified Body assessment might be required.

Toys Safety Directive

The Toy Safety Directive establishes safety requirements for toys intended to be used by children under 14 years of age.

The Toy Safety Directive requires the involvement of a notified body under the following circumstances:

• No harmonized standard applies to the product
• The product does not meet the requirements of the existing harmonized standards
• The manufacturer or importer see the necessities of using Notified Body services

Here some examples of products that might require Notified Body assessment:

• Painting tools
• Board games
• Electrical toys
• Cradles

Personal Protective Equipment (PPE)

The Personal Protective Equipment (PPE) Regulation lays down safety and health requirements for personal protective equipment placed in the EU market.

The PPE Regulation classifies the personal protective equipment into three categories, which are Category I, II, and III, depending on the functionality of the devices. Currently, the regulation requires that the PPE of Category II and III requires a Notified Body assessment.

Here some examples of products that might require Notified Body assessment:

• Safety spectacles and goggles
• Industrial helmets and bump caps
• Chemical resistant gloves
• Respirators

Medical Devices Regulation

The Medical Devices Regulation sets up a regulatory framework to ensure the safety and efficacy of medical devices and facilitates the process of risk control and smooth circulation of these products in the EU market.

The regulation classifies medical devices into four classes: Class I, IIa, IIb, and III, depending on the complexity and the device’s degree of invasiveness. The higher the class is, the stricter the rules that apply to the products.

Most medical devices require the involvement of a Notified Body. Class I medical devices that meet the following conditions are exempted by this requirement:

• Non-sterile product
• Do not have any measuring function

Machinery Directive

The Machinery Directive establishes safety requirements for a wide range of machinery, parts, and components.

The involvement of a Notified Body is necessary only for machinery mentioned in Annex IV that are not fully covered by harmonized standards, or for which such standards don’t exist.

The following are some examples of machinery that are required a Notified Body compliance assessment:

• Hand-fed surface planing machinery for woodworking
• Hand-fed vertical spindle molding machinery for working with wood
• Portable chainsaws for woodworking

How do I find a Notified Body?

The European Commission provides a regularly-updated list of notified bodies in the NANDO (New Approach Notified and Designated Organisations) System, which allows users to search Notified Bodies based on their country, their 4-digit code the directives and regulations for which they are designated, and other categories.

Currently, there are more than a few hundred notified bodies. Some of the largest companies like the SGS are designated as Notified Body in several countries and can provide services for a large array of products, such as:

• Electronic equipment
• Medical devices
• Hot-water boilers
• Machinery
• Construction products

As another example, Intertek is designated as a Notified Body for the following class of products:

• Medical devices
• Radio equipment
• Electronic products
• Personal protective equipment
• Appliances burning gaseous fuels

Can I use a Notified Body even if it’s not required for my product?

For some directives, such as the Low Voltage Directive or the RoHS Directive, there is not such a possibility as the legislation doesn’t include this option, and thus there is no such thing as “Notified Body designated for the Low Voltage Directive”.

If a Directive requires the involvement of a Notified Body for some class of products, in some cases it’s still possible to use a Notified Body to carry out a conformity assessment even if it’s not required for your specific product.

Let’s take the Toy Safety Directive as an example, and let’s assume that your toy is fully covered by harmonized standards, and you manufacture it in accordance with such technical requirements.

In this case, you don’t need the involvement of a Notified Body. However, according to Article 19 of the Directive, you can still use one, if you deem that the design or purpose of the product necessitates third-party verification.

Do importers need a Notified Body?

Yes. Any party that is looking to import products that require the involvement of a Notified Body, should contact one to perform the conformity assessment. This includes:

• Importers based in the EU
• Manufacturers based in the EU
• Companies based outside the EU, who wish to export and market their product within the EU market

Can a Notified Body be located outside the EU?

Notified Bodies are designated by EU member states and are located in the EU.

Several countries have signed the Mutual Recognition Agreements (MRAs) to facilitate trades and market access with the European Union. Similar to the Notified Body system in the EU, these countries have designated lists of Conformity Assessment Bodies (CABs) for certain categories of products.

Products that have acquired the necessary approval from a CAB in one of these countries do not need to be assessed by a Notified Body in the EU, in order to be imported into the EU market.

Currently, the following countries have signed MRAs with the EU:

• Australia
• Canada
• Israel
• Japan
• New Zealand
• Switzerland
• United States

Decision 2006/654/EC

There is an exemption for Turkey, which is not part of the EU.

How much does a Notified Body charge?

The cost of hiring a Notified Body might vary greatly, depending on the complexity of the product, documentation review days, company pricing policy, the number of employees involved, assessment plan, and other factors.

Here some examples for your reference:

1. US$3-4,000 per Technical Documentation examination’s day for Class III medical devices

2. US$1,200-200 per Technical Documentation review’s day for other products

3. US$1,500-2,000 per quality management system audit day, which is required for some classes of products, such as medical devices