Guide to EU-type Examination Certificates

Certain products can only be sold in the European Union if a notified body has first carried out an EU-type examination. This is the case for certain types of PPE, medical devices, toys, and other products which require CE marking.

This procedure involves reviewing documentation and physical samples. If the examination is successful, an EU-type examination certificate (also known as an EC-type examination certificate) is issued.

This guide explains how you can determine if your product requires an EU-type examination certificate, and what you must do to obtain one.

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 aspects of a product and verifies that the 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 manufacturer.

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.

Are EU-type examination certificates mandatory?

Yes, if the product is subject to a conformity assessment which mandates an EU-type examination certificate. There are two primary scenarios to consider:

a. Your product belongs to a certain category or class that requires an examination certificate

b. An EU-type examination certificate is only required under special circumstances (i.e., the manufacturer has voluntarily chosen to not follow established product standards).

The examples below illustrate how you can determine if this is the case for a particular product.

Toy Safety Directive

1. Article 19 states that toys must undergo EC-type examination by a notified body if the manufacturer has decided not to implement harmonised standards.

2. Annex IV states that the EC-type examination certificate must be included in the technical documentation.

3. As such, the certificate is only needed if harmonised standards are not followed, in which case the safety of the toy needs to be validated by a notified body.

PPE Regulation

1. Article 19 explains that PPE category II is subject to EU type-examination (module B).

2. Module B can be found under Annex V, which requires that a notified body carry out an EU type-examination and issue a certificate.

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6.1. Where the type meets the applicable essential health and safety requirements, the notified body shall issue an EU type-examination certificate to the manufacturer.

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3. As such, an EC-type examination certificate is mandatory for all products defined as PPE category II.

Which products require an EU-type examination certificate?

The list below provides examples of products that may require an EU-type examination certificate or an EC-type examination certificate.

PPE Regulation (EU) 2016/425

a. Bicycle helmets

b. Chemical protective vests

c. Flame-retardant clothing

Medical Devices Regulation (EU) 2017/745

a. Neuro-endoscopes

b. Temporary pacemaker leads

c. Absorbable sutures

In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

a. Device intended for molecular RhD blood group typing

b. Foetal RhD typing kit

c. Pre-transfusion ABO compatibility test cards

Toy Safety Directive 2009/48/EC

Any toy may require an EC type-examination certificate in any of the following cases:

a. There are no harmonised standards for the product

b. There are harmonised standards, but they were not applied

c. The importer or manufacturer decides that it is necessary to use a notified body

Battery Regulation (EU) 2023/1542

Module G, which requires a certificate, can be used for batteries that are not manufactured in series. Here are some examples:

a. Industrial batteries

b. Electric vehicle batteries

c. LMT batteries

Note: In this case, the certificate issued by the notified body is called “Certificate of Conformity”

Radio Equipment Directive 2014/53/EU

Any radio equipment may require an EU-type examination certificate when:

a. No harmonised standards for the product exist, or

b. The standards exist, but they were not fully applied

Machinery Regulation (EU) 2023/1230

a. Circular saws

b. Vehicle servicing lifts.

c. Hand-fed surface planing machinery for woodworking

Gas Appliances Regulation (EU) 2016/426

a. Series-manufactured appliances

b. Series-manufactured fittings

Pressure Equipment Directive 2014/68/EU

a. Safety accessories

b. Vessels intended to contain an unstable gas

c. Portable extinguishers and bottles for breathing equipment

Simple Pressure Vessels Directive 2014/29/EU

a. Vessels where the product of PS × V exceeds 3,000 bar

b. Vessels where harmonised standards were not fully applied

Equipment for Explosive Atmospheres (ATEX) Directive 2014/34/EU

a. Equipment intended for use in underground parts of mines

b. Equipment intended for use in areas in which explosive atmospheres may be caused by mixtures of air and gases

c. Equipment intended for use in areas in which explosive atmospheres may be caused by mists or by air/dust mixtures

EU-type examination certificate example

Who can issue an EU-type examination certificate?

Only a Notified Body can issue EU-type examination certificates. These are generally required to be located in the European Union.

Note that notified bodies are specialised. For example, a few years ago we worked on a project involving safety shoes and found one notified body for PPE in Sweden where the customer was located. Despite this, safety shoes were outside of their scope, and we had to go to SGS in Finland for the EU-type examination instead.

You can find notified bodies in the NANDO database.

What information is included in the EU-type examination certificate?

The specific information depends on the requirements set by the applicable EU regulation or directive which mandates it. This is, for example, what an EU-type examination certificate for PPE must contain:

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(a) the name and identification number of the notified body;

(b) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the latter’s name and address;

(c) identification of the PPE covered by the certificate (type number);

(d) a statement that the PPE type complies with the applicable essential health and safety requirements;

(e) where harmonised standards have been fully or partially applied, the references of those standards or parts thereof;

(f) where other technical specifications have been applied, their references;

(g) where applicable, the performance level(s) or protection class of the PPE;

(h) for PPE produced as a single unit to fit an individual user, the range of permissible variations of relevant parameters based on the approved basic model;

(i) the date of issue, the date of expiry and, where appropriate, the date(s) of renewal;

(j) any conditions attached to the issue of the certificate;

(k) for category III PPE, a statement that the certificate shall only be used in conjunction with one of the conformity assessment procedures referred to in point (c) of Article 19.

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How much does an EU-type examination certificate cost?

The cost depends entirely on the product type and complexity. It should also be noted that you are paying for the examination procedure, rather than the certificate itself.

Relevant factors

• Applicable regulation/s and directive/s
• 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

Cost Examples

Example A: Examine technical file – 700 to 2000 EUR

Example B: Machinery examination – 6500 to 20,000 EUR

Example C: PPE Category II examination – 5000 to 15,000 EUR

What kind of documents do we need to submit to the notified body?

The specific documents depend on the regulation and directive, and the applicable conformity assessment procedure. For example, Annex V of the PPE regulation requires that the manufacturer submit the following for PPE category II:

1. Manufacturer name and address

2. Written declaration that the same application has not been lodged with any other notified body

3. Technical documentation

4. Product samples

As such, you must provide both documents and physical product samples before the notified body can start the procedure, which (if successful) results in an EU-type examination certificate.

Who will check if we have an EU-type examination certificate?

Market surveillance authorities carry out routine checks. This means that they contact companies to request and review their certificates.

This can happen at any time, and may occur years after a product has been introduced.

The customs authorities in EU member states can also request EU-type examination certificates when you are importing PPE, medical devices, or other items that require certification.

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 before you introduce the product on the market.

Selling such products without the EU-type certificate could lead to the following:

• Product recalls
• Fines
• Sales bans
• Amazon removals
• Customs seizing cargo

Do we need an EU-type examination certificate when selling on Amazon in the EU?

Yes, if you sell products that require an EU-type examination certificate or EC-type examination certificate, then it is also required when selling on Amazon in the European Union.

Amazon also has routines in place to verify if medical devices, PPE, and other products which are subject to EU-type examination are correctly certified. They will almost certainly remove a product that fails a check.

Do we need a DoC if we have an EU-type examination certificate?

Yes, an EU-type examination certificate is not a substitute or replacement for a Declaration of Conformity. These two documents fulfil different purposes and one does not exclude the other.

On the contrary, the notified body generally reviews the Declaration of Conformity as part of the EU-type examination.