Many products that require the CE mark can be ‘self-certified’ in the sense that you as an importer or manufacturer can arrange testing and prepare documentation (e.g. DoC and technical file) entirely on your own. However, when it comes to some product categories – an external review of the compliance procedure, including the DoC and technical file, is required.
In this guide, we explain how this works and why an EU-type examination certificate is a central component in this process.
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What is an EU-type examination certificate?
The EU-type examination is part of a conformity assessment procedure performed by a Notified Body, which examines the technical aspect of a product and verifies that such product meets the essential requirements of the relevant directives and regulations. If the product meets the requirements, the Notified Body issues an EU-type examination certificate to the importer or manufacturer.
What is the purpose of an EU-type examination certificate?
An EU-type examination certificate is used to demonstrate that the product complies with the essential technical requirements, after passing a conformity assessment procedure carried out by a Notified Body.
As we explained in the previous section, the EU-type examination certificate only applies to products covered by certain CE directives or regulations – mainly products that might present a high level of risk for the user.
Which products require an EU-type examination certificate?
Currently, only products that are covered by certain CE directives or regulations that require the involvement of a Notified Body need to be assessed through an EU-type examination and obtain an EU-type examination certificate. Such directives and regulations include:
- EMC Directive
- Personal Protective Equipment Directive
- Radio Equipment Directive
- Toy Safety Directive
- Machinery Directive
Note that, for the Toy Safety Directive, the certificate is called an EC-type examination certificate. Further, EU-type examination certificate is not required for all products that fall within the scope of the listed directives.
Device Classes
There are different categories of products that might require an EU-type examination. For example, high-risk products (or products that protect from high risks) such as:
a. Class II or III personal protective equipment (e.g. protective footwear, bicycle helmets)
b. Equipment or devices that are intended to be used in potentially explosive or high-pressure atmospheres (e.g. products covered by the Gas Appliances Regulation)
c. Class II and III medical devices (e.g. stents, implantable pacemakers)
EN Standards
Also, for some categories of products, the EU-type examination by Notified Body might be required when harmonized standards for the product do not exist. Or, if the importer or manufacturer decided to not use them. Here are some examples of these products:
- Toys
- Radio devices
In some cases, for instance for products under the Toy Safety Directive, manufacturers and importers might also voluntarily opt for this type of procedure because they assess that the use of a Notified Body is necessary to ensure product safety.
When is an EU-type examination certificate required?
An EU-type examination certificate might be required for products that are covered by CE directives or regulations that require the involvement of Notified Body. Such directives include:
- Electromagnetic Compatibility Directive
- Toy Safety Directive
- Radio Equipment Directive
- Personal Protective Equipment Regulation
- Machinery Directive
In some cases, for instance for products that fall under the scope of the Personal Protective Equipment Regulation, the EU-type examination certificate is required only for products that belong to certain classes (e.g. for products that belong to Class II or Class III).
In other cases, for instance for products that fall under the Toy Safety Directive, it might be required if harmonized standards do not exist for a product, harmonized standards exist but the manufacturer or importer chose to do not apply them, or because the manufacturer or importer deems the use of a Notified Body necessary to ensure product safety.
What information is included in the EU-type examination certificate?
The content of EU-type examination certificates might differ depending on the directives or regulations. Below is some example of information that should be contained in the EU-type examination certificate under the Electromagnetic Compatibility (EMC) Directive:
a. Name and address of the manufacturer
b. Conclusions of the examination
c. Requirements covered by the examination
d. Conditions for the certificate’s validity (e.g. period of validity)
e. The necessary data for identification of the approved type
Other directives or regulations might mention other information. For instance, the Personal Protective Equipment Regulation mentions:
“Name and identification number of the notified body”
Both the Personal Protective Equipment Regulation and the Toy Safety Directive mention:
“Identification of the product”
Importers or manufacturers should read carefully after receiving the EU-type examination certificate issued by the Notified Body to confirm whether it contains all the necessary information required by the relevant directive or regulation.
How much does it cost?
The cost of hiring a Notified Body to conduct an EU-type examination depends on many factors, such as:
- Type and complexity of the product
- Types of documents to be assessed
- Examiners’ working hours
- Number of examiners involved
- Service plans
- Travel fees
- Unannounced audit fees
For instance, the cost of hiring a Notified Body to examine a technical file for a radio device might be as little as USD 650, according to this impact assessment published on service.gov.uk. You will have to also add the cost of relevant testing required by the Notified Body, which might vary greatly according to the product, and other services when required.
For complex products, such as medical devices, the cost might be higher than USD 20,000. We can use the example of Intertek and TÜV SÜD’s Medical Device examination and certification fees in 2021 as a reference.
Intertek (Non-exhaustive list)
- Auditing fee: USD 4,124
- Technical documentation sampling and assessment fee: USD 11,753
- Technical documentation assessor fee: USD 412/hour
- Clinician assessment fee: USD 567/hour
There are additional fees for other items or devices, importers or manufacturers should contact Intertek for the latest quotation.
TÜV SÜD (Non-exhaustive list)
- Audit: USD 320/hour
- Clinical audit: USD 320/hour
- Technical documentation assessment offsite fee: USD 431/hour
- Clinician assessment fee: USD 431/hour
- Technical documentation assessment onsite for Class Irsi, Class Is, Class Im* and Class II non-implantable fee: USD 541
There are additional fees for other items or devices, importers or manufacturers should contact TÜV SÜD for the latest quotation.
What kind of documents do we need to submit?
Importers or manufacturers applying for an EU-type examination certificate should provide at least the following information to the Notified Body:
a. the name and address of the manufacturer or its authorized representative
b. a written declaration that the same application has not been lodged with another notified body
c. the technical documentation, which might contain a product description, a list of harmonized standards applied in full or in part, and more
Note that additional information might be required.
Who can issue a EU-type examination certificate?
An EU-type examination certificate is issued by a Notified Body that is designated by relevant authorities in a specific state member (e.g. France) and for a specific directive (e.g. Toy Safety Directive).
Thus, a given Notified Body can only perform conformity assessments in a specific country, and for specific directives or regulations (typically not more than three-four, but in some cases, it might be just one).
You can check the list of Notified Bodies on the European Commission’s website.
What can happen if we don’t have this certificate?
If your products are required to have an EU-type examination certificate by relevant directives or regulations, then you should obtain one.
Selling such products without the EU-type certificate could lead to recalls, customs denying entry of the product into the EU, Amazon removals, or other punitive measures by the authorities.
Seek NB for EC TYPE EXAMINATION for chemical experiment combine set.