EU Conformity Assessment Procedures: A Complete Guide

A conformity assessment procedure provides a pathway to compliance for certain EU regulations or directives that require CE marking. In practice, conformity assessment procedures set a list of tasks that must be completed to demonstrate compliance. This generally involves compliance with standards, documentation, labelling, and testing.

In this guide, we explain how you can determine which conformity assessment procedure to follow for your products, and the steps you must take to successfully complete the procedure.

What is a Conformity Assessment Procedure?

A conformity assessment procedure describes a series of actions that must be completed in order to fully comply with a certain EU regulation or directive.

Process overview

This can include the following:

1. Identify the applicable standards

2. Draw up a written EU declaration of conformity

3. Create technical documentation

4. Affix CE marking and other label information

5. Product testing

How conformity assessment procedures differ

In practice, the applicable conformity assessment procedure can determine the following:

1. Which module or modules must you follow

2. What information must you include in your Declaration of Conformity

3. What you need to include in the technical documentation

4. Whether the manufacturer can or cannot self-manage the procedure

5. Whether a notified body is required

6. Whether your product needs an EC-type examination certificate

7. Labelling requirements

Generally speaking, products that have a higher risk level are subject to stricter conformity assessment procedures. Certain PPE categories and medical device classes are examples of such products.

Other products are still subject to a conformity assessment procedure. Still, they may not be as strict in terms of requirements or mandate the involvement of a notified body – thus allowing the manufacturer to self-manage the process instead.

As the applicable conformity assessment procedure decides the path to achieve compliance with a certain regulation or directive, it is essential that you determine the specific procedure applicable to your product early in the process.

Which products require that we follow a Conformity Assessment Procedure?

Essentially all products that require CE marking must comply with one or more conformity assessment procedures. Here are some examples of product categories subject to regulations and directives mandating CE marking:

• Toys
• Electronics
• Machinery
• Batteries
• Personal protective equipment
• Medical devices
• Measuring instruments
• Gas appliances

Who is responsible for implementing the Conformity Assessment Procedure?

The manufacturer is generally responsible for ensuring that the correct conformity assessment procedure is followed.

The specific wording can often be found under the article covering obligations of manufacturers. Here is an example from the PPE regulation:

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Article 8 – Obligations of manufacturers

2. Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the applicable conformity assessment procedure referred to in Article 19 or have it carried out.

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For context, manufacturers generally refer to companies that either manufacture products or use other manufacturers to produce their products. This is also the case for companies branding products. As such, many companies without actual production capacity are defined as manufacturers.

Importers, on the other hand, are not responsible for actually carrying out the conformity assessment procedure. They are, however, responsible for verifying that the correct conformity assessment procedure has been carried out by the manufacturer.

Doing so requires a deep understanding of the steps that must be taken, and the documentation needed to demonstrate that.

How do I determine which Conformity Assessment Procedure applies to my product?

For starters, you must determine all applicable EU regulations and directives that apply to your product. You must then identify the article or articles specifying the conformity assessment procedure requirements.

Here is an example from the PPE regulation:

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Article 19 – Conformity assessment procedures

The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:

(a) Category I: internal production control (module A) set out in Annex IV;

(b) Category II: EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;

(c) Category III: EU type-examination (module B) set out in Annex V, and either of the following:

(i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;

(ii) conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.

By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.

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As you can see above, the applicable conformity assessment procedure can depend on the product type, or in this case, the PPE category.

That being said, the following factors can also determine the applicable conformity assessment procedure:

• Product features or functionality
• Whether you have applied harmonised standards
• Internal quality management system

Where can I find the Conformity Assessment Procedure described?

The specifics of the relevant conformity assessment procedure can often be found in the annexes of the applicable EU regulations and directives.

Here are a few examples:

PPE Regulation

• PPE Category I: Annex IV
• PPE Category II: Annexes V and VI
• PPE Category III: Annex V, and either Annex VII or VIII

Medical Devices Regulation

• Class I device (other than custom-made or investigational devices): Article 52(7)*
• Class IIa device: Annex IX, or Annex XI
• Class IIb device: Annex IX, or Annexes X and XI
• Class III device: Annex IX, or Annexes X and XI
• Custom-made devices: Annexes XIII, and IX or XI
• Investigational devices: requirements set out in Articles 62 to 81

*The requirements concerning Annex IX (or Annex XI) only apply for devices in sterile condition, that have a measuring function or are reusable surgical instruments.

What are the different types of Conformity Assessment Procedures?

Here is an overview of different types of conformity assessment procedures based on the PPE regulation:

• Internal production control (allows for self-management of the process)
• EU-type examination (notified body requirement)
• Conformity to type based on internal production control
• Conformity to type based on internal production control plus supervised product checks at random intervals
• Conformity to type based on quality assurance of the production process

Conformity assessment procedures generally exist on a spectrum with more or less control given to the manufacturer to self-manage the process. On one end, manufacturers are allowed to self-manage the process, while others require various levels of involvement from notified bodies and other third parties.

What are Conformity Assessment Procedure modules?

Modules are essentially standardised conformity assessment procedures. They contain pre-defined assessment methods laid out in EU Decision 768/2008/EC.

Module	Description	Notified body
Module A	Internal production control	Not required
Module A1	Internal production control plus supervised product testing	Required
Module A2	Internal production control plus supervised product checks at random intervals	Required
Module B	EC-type examination	Required
Module C	Conformity to type based on internal production control	Not required
Module C1	Conformity to type based on internal production control plus supervised product testing	Required
Module C2	Conformity to type based on internal production control plus supervised product checks at random intervals	Required
Module D	Conformity to type based on quality assurance of the production process	Required
Module D1	Quality assurance of the production process	Required
Module E	Conformity to type based on product quality assurance	Required
Module E1	Quality assurance of final product inspection and testing	Required
Module F	Conformity to type based on product verification	Required
Module F1	Conformity based on product verification	Required
Module G	Conformity based on unit verification	Required
Module H	Conformity based on full quality assurance	Required
Module H1	Conformity based on full quality assurance plus design examination	Required

How do I know which module to implement?

This is normally specified in the applicable Annex listing the conformity assessment procedure. For example, Annex IV: Internal Production Control in the PPE regulation states that Module A must be followed for PPE Category I.

What is the difference between Conformity Assessment Procedures and modules?

A conformity assessment procedure describes the overall process and reference modules as subprocedures.

What happens once the Conformity Assessment Procedure is completed?

Correctly completing all the required steps under a conformity assessment procedure should mean that your product is compliant with the relevant EU regulation or directive.

Bear in mind that products can be subject to more than one regulation or directive, and thus also subject to several different conformity assessment procedures.

Summary

1. Determine if you are defined as a manufacturer or other economic operator

2. Determine if your product belongs to a particular class, category, or other subgroup

3. Identify the Annex that contains the applicable conformity assessment procedure/s and module/s

4. Read the Annex to understand the tasks you must complete as part of the conformity assessment/s