One of the most common misconceptions surrounding CE marking is that every product must be tested, inspected or certified by an independent European Notified Body before the CE mark can be applied.
That is not how the European conformity-assessment system works. The procedure required for a product is determined by the applicable EU Directive or Regulation, the product classification and, in certain frameworks, the level of risk or conformity-assessment route selected by the manufacturer.
Some European product legislation permits the manufacturer to complete conformity assessment through internal production control without mandatory intervention by a Notified Body. Other legislation requires independent third-party involvement for specified product categories, risk classes or conformity-assessment modules.
The critical question is therefore not simply whether a manufacturer wants a certificate. The manufacturer must first determine which conformity-assessment procedure is legally required for the exact product.
Where a Notified Body is required, selecting the organisation is itself a regulatory decision. The body must be officially notified for the applicable legislation and possess the appropriate notified scope for the product and conformity-assessment activity concerned.
This GAR Insight explains the difference between manufacturer self-assessment and mandatory third-party conformity assessment, how conformity modules operate, when Notified Body involvement may be required, how to verify a body’s scope and how third-party evidence should connect with the manufacturer’s technical documentation, EU Declaration of Conformity and CE marking.
Navigate This Article
Explore EU conformity assessment, manufacturer self-assessment, Notified Body involvement, conformity modules, NANDO verification and third-party evidence within the CE marking process.
What Is Conformity Assessment?
Conformity assessment is the process used to demonstrate whether specified requirements relating to a product have been fulfilled.
Within the CE marking framework, the applicable EU product legislation defines the conformity-assessment procedure or procedures available for the particular product.
Depending on the legislation, conformity assessment can involve activities performed entirely by the manufacturer, activities requiring an independent conformity assessment body, or a combination of both.
Is a Notified Body Always Required for CE Marking?
No. CE marking does not automatically require certification by a Notified Body.
In some regulatory frameworks and conformity routes, the manufacturer can carry out the required conformity assessment and assume responsibility for demonstrating compliance without mandatory third-party intervention.
In other cases, the applicable EU legislation requires assessment by a Notified Body because of the product category, level of risk, conformity module or other conditions established by law.
Notified Body Not Mandatory
Where the legislation permits internal production control or another manufacturer-led procedure, the manufacturer can complete the conformity assessment without mandatory Notified Body involvement.
Notified Body Required
Where the applicable legislation requires independent conformity assessment, an appropriately notified organisation must perform the specified assessment activity.
What Is a Notified Body?
A Notified Body is a conformity assessment organisation designated by the relevant national authority and notified for specified conformity assessment activities under particular EU product legislation.
Notification is scope-specific. An organisation’s status as a Notified Body under one Directive or for one product group does not automatically authorise it to perform notified activities under every other EU framework.
Designated
The organisation is designated through the relevant national notification system.
Legislation-Specific
Notification relates to identified EU Directives or Regulations.
Scope-Specific
The body’s competence and notification apply only to the activities and products included within its notified scope.
Officially Identified
Notified Bodies are assigned identification numbers used within the European conformity framework.
Understanding EU Conformity Assessment Modules
European product legislation frequently uses conformity-assessment modules or procedures defining how design and production conformity are to be demonstrated.
The modules provide a common regulatory toolbox, but the actual options available for a particular product are specified in the applicable Directive or Regulation.
| Module | General Function | Typical Assessment Character |
|---|---|---|
| A | Internal Production Control | Manufacturer-controlled conformity assessment |
| B | EU-Type Examination | Notified Body examination of product type/design |
| C | Conformity to Type | Production conformity with approved type |
| D | Production Quality Assurance | Quality-system based production conformity |
| E | Product Quality Assurance | Quality assurance relating to product inspection/testing |
| F | Product Verification | Verification against approved type or requirements |
| G | Unit Verification | Assessment of individual product/unit |
| H | Full Quality Assurance | Quality-system based conformity assessment |
Internal Production Control — When Self-Assessment Is Permitted
Internal production control is a conformity-assessment approach under which the manufacturer fulfils the applicable obligations and declares responsibility for ensuring that the product satisfies the relevant legislative requirements.
Where the applicable legislation permits this route, mandatory Notified Body intervention may not be required.
Product Classification
Confirm that the legislation permits the manufacturer-led route for the relevant product.
Applicable Requirements
Identify and assess all essential or other mandatory requirements.
Standards
Apply appropriate harmonised standards or other technical solutions.
Testing
Complete the verification necessary to demonstrate conformity.
Technical File
Maintain the required conformity evidence and technical documentation.
EU Declaration
Issue the applicable Declaration of Conformity and assume responsibility for conformity.
EU-Type Examination
EU-type examination is a conformity-assessment procedure in which a Notified Body examines the technical design of a product and verifies that it satisfies the applicable requirements covered by the procedure.
The assessment normally concerns a representative type or technical design rather than every production unit individually.
Application
Manufacturer submits the required application and technical documentation.
Technical Review
The Notified Body reviews relevant design and conformity evidence.
Examination
Required examinations and tests are performed or evaluated.
Requirements Review
Compliance with applicable requirements is evaluated.
Certificate
An EU-type examination certificate may be issued where conformity is established.
Production Route
Applicable follow-up production conformity requirements are completed.
Change Control
Relevant product modifications are reviewed against the approved type.
Documentation
Certificates and assessment evidence are maintained in the technical file.
From Approved Type to Manufactured Product
Where an EU-type examination forms part of the conformity route, manufacturers must also ensure that production equipment continues to conform to the assessed type and applicable requirements.
Conformity to Type
Manufactured products are controlled to remain consistent with the approved type.
Production Quality Assurance
An approved quality system can form part of the production conformity route where provided by legislation.
Product Quality Assurance
Inspection and testing controls can support ongoing conformity under applicable modules.
Product Verification
Products or samples may be examined and tested under specified conformity procedures.
Notified Body Requirements Differ by EU Legislation
There is no universal Notified Body rule covering all CE-marked products. Each Directive or Regulation establishes its own conformity assessment system.
| Regulatory Area | General Conformity Consideration | Notified Body Question |
|---|---|---|
| Low Voltage | Manufacturer conformity assessment framework | Mandatory Notified Body certification is not the standard conformity route under the LVD. |
| EMC | Technical documentation and conformity assessment | Check the conformity procedure established by the Directive. |
| Radio Equipment | Conformity route depends on technical circumstances and procedure | Determine whether the selected RED procedure requires a Notified Body. |
| Pressure Equipment | Conformity procedures depend significantly on equipment category | Higher-risk classifications can require third-party involvement. |
| ATEX Equipment | Procedure depends on equipment group/category and protection concept | Determine the legally prescribed assessment route. |
| PPE | Conformity route depends on PPE risk category | Category II and III products involve specified third-party procedures. |
| Machinery | Route depends on applicable machinery legislation and product classification | Verify current and transitional requirements for the exact machinery category. |
How to Select the Correct Notified Body
When third-party conformity assessment is required, selecting a recognised organisation by name or reputation alone is not sufficient.
The manufacturer must establish whether the organisation is actually notified for the relevant legislation, product field and conformity assessment procedure.
Using NANDO to Verify a Notified Body
The European Commission maintains the NANDO system — the official database for organisations notified or designated under relevant European product legislation.
Manufacturers should use the official notified-body information to confirm that the organisation selected for a mandatory conformity assessment has the correct legal and technical scope.
Identification Number
Confirm the four-digit Notified Body identification number.
Organisation
Confirm the legal name and notified organisation information.
Legislation
Confirm notification under the Directive or Regulation applicable to the product.
Scope
Review notified products, procedures, modules and other scope details.
When Does the Notified Body Number Appear With CE Marking?
The presence of a four-digit Notified Body identification number next to CE marking depends on whether the applicable conformity assessment procedure requires the body’s involvement in the production control phase under the relevant legislation.
It should not be added simply because a laboratory performed testing or because a third-party certificate exists.
Manufacturer Assessment
Where the applicable conformity procedure does not require a Notified Body in the relevant production-control role, the CE mark is not accompanied by a Notified Body number for that reason.
Relevant Notified Body Involvement
Where the applicable legislation and conformity procedure require the Notified Body’s involvement in the production-control phase, its identification number accompanies the CE marking as prescribed.
Notified Body Certificates & the Technical File
Where a Notified Body participates in the required conformity assessment, the resulting certificates and supporting documents become part of the manufacturer’s conformity evidence.
These documents should be integrated into the technical file together with the product design information, risk assessment, standards, test reports, production controls and EU Declaration of Conformity.
Certificate
Maintain the relevant EU-type examination or other conformity certificate where applicable.
Assessment Report
Retain supporting assessment information relevant to the conformity decision.
Product Identification
Ensure the assessed model corresponds with the finished product.
Conditions & Limitations
Identify any restrictions or conditions attached to the assessment.
Production Evidence
Maintain follow-up quality or verification evidence where required.
Change Records
Document modifications that may affect the validity of third-party assessment.
Common Notified Body & Conformity Assessment Mistakes
Assuming Every CE Product Needs Certification
Unnecessary third-party certification is purchased without first determining the legally required conformity route.
Assuming Testing Equals Notification
A laboratory test report is incorrectly treated as a Notified Body conformity assessment.
Using the Wrong Notified Body Scope
The organisation is notified under EU legislation, but not for the product or procedure being assessed.
Using an Accreditation Logo as Proof
Accreditation is incorrectly treated as evidence of notification for the relevant EU legislation.
Wrong Conformity Module
A conformity procedure is selected without confirming that it is permitted for the product classification.
Ignoring Production Conformity
Type examination is completed but the required production conformity procedure is overlooked.
Adding the NB Number Incorrectly
The four-digit identification number is placed beside CE marking when the applicable conformity procedure does not justify it.
Uncontrolled Product Changes
Components, design or software change after certification without assessing implications for the approved product.
From Product Classification to CE Marking
A reliable conformity-assessment programme should establish the legal route before laboratories, certification organisations or Notified Bodies are engaged.
Define Product
Establish configuration, intended use and technical characteristics.
Classify Product
Determine the legally relevant product category and risk level.
Map Legislation
Identify all applicable EU Directives and Regulations.
Identify Requirements
Establish applicable essential or other mandatory requirements.
Determine Procedure
Identify the legally available conformity-assessment route.
Check NB Requirement
Determine whether mandatory third-party involvement applies.
Select Standards
Establish harmonised and other technical standards.
Complete Testing
Generate required technical conformity evidence.
Select Notified Body
Where required, verify notification and scope through NANDO.
Complete Assessment
Complete the applicable manufacturer and third-party procedures.
Build Technical File
Integrate testing, certificates and conformity evidence.
Declare & CE Mark
Issue the EU DoC and apply CE marking as legally required.
Notified Body Involvement Is Determined by Law — Not by the CE Mark Itself
The presence of CE marking does not tell an observer whether an independent conformity assessment organisation was involved in bringing the product to market.
For some products, the manufacturer can complete the applicable conformity-assessment procedure internally, prepare the required technical documentation, issue the EU Declaration of Conformity and affix CE marking without mandatory Notified Body intervention.
For other products, their classification, risk category or applicable conformity module makes independent assessment mandatory. In those circumstances, a properly notified organisation becomes an essential part of the legal conformity process.
The distinction is important because unnecessary certification can add cost and delay without creating additional legal validity, while failing to involve a Notified Body where one is mandatory can fundamentally undermine the conformity of the product.
Manufacturers should therefore determine the applicable conformity route before requesting quotations for certification. Once third-party involvement is established as necessary, the selected organisation should be verified against its official notified scope for the legislation, product and procedure concerned.
The resulting certificates and assessment records should then become part of a wider evidence chain incorporating design documentation, risk assessment, applicable standards, test reports, production controls, technical documentation and the manufacturer’s EU Declaration of Conformity.
The Regulatory Question
Does the legislation applicable to the exact product classification permit manufacturer conformity assessment, or does it require independent third-party involvement?
The Notified Body Question
Where third-party assessment is mandatory, is the selected organisation officially notified for the exact legislation, product scope and conformity-assessment procedure required?