Introduction
One of the most frequent questions in the CE Marking process is whether the manufacturer can carry out the conformity assessment on their own or if they need the intervention of a notified body.
The answer depends on the type of product, the applicable legislation, the conformity assessment procedure, and the associated risk level. Not all products subject to CE marking require a notified body, but in some cases, its participation is mandatory to demonstrate conformity before placing the product on the market.
In this article we explain what a notified body is, when it may be necessary, what the difference is between internal assessment, certification and CE Marking, and what the manufacturer should check before proceeding.
Table of Contents
- What is a notified body?
- Do all products with CE marking require a notified body?
- When is a notified body required for CE Marking
- Examples of products where a notified body may be involved
- How to know if your product needs a notified body
- Difference between a notified body, a laboratory, and a technical consultant
- Notified Body and EU Declaration of Conformity
- Common mistakes when assessing whether a notified body is needed
- Checklist to find out if you need a notified body
- How DEKRA can help you
- Frequently asked questions about notified bodies and CE marking
1. What is a notified body?
A notified body is an entity designated by a competent national authority and notified to the European Commission to carry out specific conformity assessment tasks within a given European legislation.
Its function may vary depending on the product and the applicable procedure. In some cases, it involves reviewing technical documentation ; in others, it involves conducting tests, audits, type evaluations, certifications, or controls on the manufacturer's quality system.
The important thing to understand is that a notified body does not participate in all CE Marking processes . It only participates when the legislation applicable to the product requires an assessment by an authorized third party.
2. Do all products with CE Marking require a notified body?
No. Many products subject to CE Marking can be assessed through internal production control procedures, provided that applicable legislation allows it and the manufacturer has sufficient evidence to demonstrate conformity.
In these cases, the manufacturer identifies the applicable requirements, carries out or coordinates the necessary tests, prepares the technical documentation and issues the EU Declaration of Conformity.
However, for higher-risk products or certain procedures established by European legislation, it may be mandatory to use a notified body.
In summary:
The CE Marking does not automatically imply the intervention of a notified body. The need depends on the product and the applicable conformity assessment procedure.
3. When is a notified body required for CE Marking
A notified body may be required when the legislation applicable to the product requires the involvement of a third party in one or more stages of the conformity assessment.
This can happen, for example, when:
- the product belongs to a high-risk category;
- the applicable directive or regulation requires third-party assessment;
- the selected compliance procedure requires external review;
- Harmonized standards are not fully applied;
- an EU type examination is required;
- An evaluation of the manufacturer's quality system is required;
- The product is included in regulated categories with specific requirements.
It should not be assumed that a product requires a notified body simply because it bears the CE marking . Nor should the opposite be assumed without reviewing the applicable legislation.
4. Some examples of products where a notified body may be involved
The involvement of a notified body always depends on the specific legislation, but it may be common in certain products or scenarios.
4.1. Medical devices
Medical devices generally require assessment by a notified body, with some low-risk exceptions. The level of intervention depends on the product class and the applicable procedure.
4.2. Pressure Equipment
Certain pressure equipment may require the intervention of a notified body depending on its category, pressure, volume, fluid and level of risk.
4.3. Machines with specific requirements
Some machines or safety components may require intervention from a notified body if they are included in specific categories or if harmonised standards are not fully applied.
4.4. Personal protective equipment
Certain personal protective equipment may require type assessment and monitoring by a notified body, especially when it protects against serious risks.
4.5. Construction Products
In construction products, the involvement of notified bodies may depend on the applicable performance assurance and verification system.
4.6. Radioelectric equipment in specific cases
In radio equipment, it may be necessary to check whether the product fully complies with applicable harmonized standards or if there are scenarios that require additional evaluation.
5. How to know if your product needs a notified body
To determine if a product requires a notified body, the manufacturer must follow a sequence of analyses.
5.1. Identify the product and its intended use
The first step is to clearly define what product will be marketed, what it is used for, who uses it, and in what environment.
5.2. Determine the applicable European legislation
It is necessary to identify which directives or regulations affect the product. A single product may be subject to several regulations simultaneously.
5.3. Review the conformity assessment procedure
Each legislation establishes evaluation procedures or modules. Some allow internal control of production, while others require intervention from a notified body.
5.4. Partial or complete application of harmonised standards
Full application of harmonized standards can facilitate demonstration of conformity. If they are not applied or are only partially applied, it may be necessary to review whether the required procedure changes.
5.5. Assess the level of risk
The risk associated with the product may influence the applicable procedure and the need for third-party assessment.
5.6. Document the decision
Whether or not a notified body is involved, the manufacturer must keep evidence of the decision taken within the technical file.
6. Difference between a notified body, a laboratory, and a technical consultant
It is common to confuse these three concepts, but they do not serve the same function.
| figure | That makes | When does it intervene? |
|---|---|---|
| Notified body | Performs conformity assessment tasks when required by law. | When the applicable procedure requires an authorized third party. |
| Testing laboratory | Perform technical tests to generate evidence of compliance. | When tests are needed to demonstrate technical requirements and the appropriate instruments are not available. Cases in which an accredited test report is required. |
| Technical or regulatory consultant | It helps to interpret requirements, prepare documentation, or define strategy. | When the person responsible for the product is unaware of the conformity assessment process. |
A laboratory may perform tests required for the technical dossier, but that does not necessarily mean that it acts as a notified body.
7. Notified Body and EU Declaration of Conformity
When a notified body is involved, its participation must be reflected in the product documentation, according to the applicable procedure.
The EU Declaration of Conformity must be consistent with the technical file, test reports, certificates issued and any intervention by the notified body.
When participating, the identification number of the notified body must accompany the CE marking, appear in the declaration of conformity, and sometimes on the labeling. This will depend on the legislation and the procedure followed.
8. Common mistakes when assessing whether a notified body is needed
X Thinking that all CE Marking requires external certification
Not all products subject to CE marking require a notified body. In many cases, the manufacturer can carry out an internal assessment if permitted by law.
X Confusing test report with notified body certificate
A test report provides technical evidence, but does not necessarily equate to a certification issued by a notified body.
X Incomplete list of applicable rules
When several standards apply to a product, each and every one of them must be reviewed, not just partially.
X Applying harmonized standards partially without analyzing the consequences
If the relevant harmonised standards are not fully applied, there is no presumption of conformity and it may therefore be necessary to complete the conformity assessment procedure.
X Failure to retain evidence of the decision
The decision to use or not use a notified body must be justified and documented within the technical file.
X Use certificates that are not applicable to the final product
Certificates for components or modules can help, but they never cover the conformity of the entire product.
9. Checklist to find out if you need a notified body
Before proceeding with CE Marking, review these questions:
- What product are you going to market?
- What is its intended use?
- In which market will it be sold?
- What directives or regulations apply?
- What conformity assessment procedure does each legislation require?
- Does the product belong to a specific risk category?
- Are full harmonized standards applied?
- Are there any deviations from the applied standards?
- Does the product require CE type examination?
- Is a quality system evaluation required?
- Should the number of a notified body appear next to the CE Marking?
- Is the decision documented in the technical file?
If any of these answers are unclear, it is advisable to review the case before marketing the product.
10. How DEKRA can help you
DEKRA can assist manufacturers, importers, and distributors in analyzing applicable requirements, identifying the conformity assessment procedure, defining necessary tests, and reviewing documentation for products subject to CE Marking.
The support may include:
- initial product analysis;
- identification of applicable directives and regulations;
- review of harmonized standards;
- definition of necessary tests;
- support in the preparation of the technical file;
- review of the EU Declaration of Conformity;
- guidance on when a notified body may be required;
- technical tests to generate evidence of conformity.
If you are unsure whether your product requires a notified body, you can start with the interactive CE Marking guide or consult your case with an expert.
11. Frequently Asked Questions about Notified Bodies and CE Marking
It is an entity officially designated to carry out specific conformity assessment tasks when required by European legislation applicable to the product.
No. Some products may be evaluated through internal production control, provided that applicable legislation allows it.
You must identify the applicable legislation, review the conformity assessment procedure, and check if it requires the intervention of an authorized third party.
No. A laboratory performs technical tests. A notified body performs conformity assessment tasks for which it has been officially designated.
It can provide an additional review, but it does not replace the manufacturer's responsibility or eliminate the need to properly prepare the technical documentation.
The product does not comply with the legal conformity assessment procedure, which creates problems for its marketing.
Only when required by applicable law and procedure. It should not be added if it is not applicable.
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