What Is CE Marking and When Is a Notified Body Required?

The term CE Certificate is frequently used when researching conformity procedures for products intended for the European Union market. However, CE marking is neither an independent quality certificate nor a general product approval issued by the European Union. It represents the manufacturer’s declaration that the product meets applicable EU harmonisation legislation requirements. These may concern safety, health, or environmental protection. Notified body assessment is not mandatory for every product requiring CE marking. Manufacturers may assess some products under their own responsibility, while others require an authorised third party. The applicable method depends on the legislation governing the product and the prescribed conformity assessment procedure.

Which Products Require CE Marking?

CE marking should only be used on products for which relevant EU legislation explicitly requires it. Electrical equipment, toys, and certain machinery are among the products that may fall under these rules.

Technical characteristics and intended use should be considered alongside the destination country. CE marking must not be affixed to products for which it is not prescribed.

The Manufacturer’s Conformity Assessment Responsibility

The manufacturer is responsible for identifying applicable legislation, assessing product risks, and preparing the necessary technical documentation. The EU declaration of conformity is drawn up once the relevant procedure is completed.

Involving a notified body does not remove the manufacturer’s legal responsibility for product conformity.

What Is Manufacturer Self-Assessment?

Where legislation permits, manufacturers may perform necessary checks and technical assessments without third-party approval. Evidence demonstrating compliance with applicable safety requirements is still required.

Self-assessment does not allow CE marking without checks. Necessary testing and technical documentation must be completed.

Initial CE Marking Checklist

• Product: Define technical characteristics and intended use.
• Legislation: Identify applicable EU legislation.
• Procedure: Examine the required conformity assessment method.
• Body: Verify whether third-party involvement is mandatory.
• Documentation: Prepare the technical file and declaration of conformity.
• Marking: Affix CE marking in accordance with the relevant rules.

When Is a Notified Body Mandatory?

If product legislation requires independent third-party assessment, a notified body authorised for the relevant procedure must participate. Product category and risk classification may affect the assessment method.

Authorisation can be checked through the EU’s NANDO database. Listing alone is insufficient; the body must be authorised for the relevant legislation and procedure.

The Difference Between CE Marking and a Certificate

CE marking indicates conformity with applicable legislation; it does not establish superior product quality. Nor does it mean that EU institutions approve every product individually.

CE conformity procedures assessed within KIOSCERT services should first identify product legislation and the assessment method. Unnecessary certificate requests should be avoided while mandatory third-party assessments must not be overlooked.

Which CE Legislation Requires a Notified Body?

In the context of a CE Certificate, notified body requirements depend on the applicable EU legislation and conformity assessment procedure. Electrical equipment, machinery, toys, medical devices, and pressure equipment do not follow identical rules. Some legislation permits manufacturer self-assessment, while other legislation requires independent involvement for particular risk categories. Where multiple EU acts apply, each act’s requirements should be examined separately. A decision should therefore not be based solely on the product group’s name.

Low Voltage and Electrical Equipment Legislation

Under the Low Voltage Directive 2014/35/EU, conformity assessment relies on the manufacturer’s internal production control. This directive does not require mandatory notified body involvement.

However, other legislation may apply to the same product. Its obligations under other applicable acts should be investigated separately.

Third-Party Assessment for Toys

Under the Toy Safety Directive 2009/48/EC, manufacturers may use internal production control where harmonised standards covering the relevant safety requirements are fully applied.

EC-type examination may be required where standards are unavailable, not fully applied, or other relevant conditions arise. A notified body performs this examination.

Notified Bodies Under Machinery Legislation

Many machines may be assessed by manufacturers under Machinery Directive 2006/42/EC. Certain machinery listed in Annex IV may require third-party involvement depending on the standards applied and procedure selected.

The general application date of Machinery Regulation (EU) 2023/1230 is 20 January 2027. The applicable legislation should be checked during the transition period.

CE Legislation Checklist

• Product: Identify technical characteristics and intended use.
• Legislation: Examine relevant directives and regulations.
• Risk: Determine the applicable product category.
• Module: Identify the conformity assessment procedure.
• Body: Verify mandatory third-party involvement.
• NANDO: Check the body’s authorised scope.

Medical Device and Personal Protective Equipment Rules

Under Medical Devices Regulation (EU) 2017/745, certain Class I devices qualify for manufacturer assessment. Sterile devices, devices with a measuring function, and reusable surgical instruments require notified body involvement for specified aspects.

Under Personal Protective Equipment Regulation (EU) 2016/425, Category I products may use internal production control, while Categories II and III require the relevant third-party procedures.

Conformity Assessment Modules and NANDO Checks

Module A means internal production control. Module B covers type examination, while certain other modules concern production or quality assurance assessments. Applicable modules must be identified from product legislation.

Pressure equipment also follows different procedures by category under Directive 2014/68/EU. KIOSCERT assessments should examine the legislation, product, and procedure authorisations in the notified body’s NANDO record together.

How Does a Manufacturer Perform Its Own Conformity Assessment?

Manufacturers researching a CE Certificate should first determine whether their products require independent notified body assessment. Where EU product legislation permits, manufacturers may perform conformity assessment under their own responsibility. This does not mean that products may be marketed without examination. Manufacturers must identify applicable legislation, assess risks, perform necessary tests, and prepare technical evidence. Self-assessment is available only within procedures prescribed by the relevant legislation. Products subject to multiple acts must meet each act’s requirements separately.

How Is Applicable EU Product Legislation Identified?

Intended use, technical characteristics, and target users should be examined. Relevant EU directives and regulations are identified from this information.

For example, electrical equipment may require separate consideration of applicable safety and electromagnetic compatibility legislation. Exclusions from scope should also be checked.

Essential Requirements and Risk Assessment

Manufacturers should identify essential health, safety, and other protection requirements. Risks arising from intended use should be analysed and protective measures documented.

Instructions alone may be insufficient to manage risks. Appropriate design measures and protective solutions should be considered.

Harmonised Standards and Product Testing

Harmonised standards whose references are published in the Official Journal of the European Union under relevant legislation may provide a presumption of conformity for the requirements they cover.

Their use is generally voluntary. Alternative technical solutions require other adequate evidence of conformity. Necessary testing should be determined according to product characteristics.

Manufacturer Conformity Assessment Checklist

• Legislation: Identify applicable EU acts.
• Risk: Assess essential requirements and product hazards.
• Standard: Examine relevant harmonised standards.
• Testing: Complete necessary inspections and tests.
• File: Document technical evidence and assessment results.
• Declaration: Prepare the declaration and affix CE marking.

How Is the Technical File Prepared?

The technical file should include the product description, design information, applied standards, risk assessment, test reports, and relevant manufacturing documents. Content should follow applicable legislation.

Documentation should be retained for submission to market surveillance authorities on request. Retention periods should follow product-specific legislation.

The EU Declaration of Conformity and CE Marking

After completing assessment, the manufacturer draws up and signs the required EU declaration of conformity. It should contain product identification, applicable legislation, and manufacturer responsibility information.

CE marking should be affixed according to relevant rules. KIOSCERT assessments should consider manufacturer responsibility alongside current technical documentation and monitoring of legislative changes.

How Is a Notified Body Verified Through NANDO?

For products requiring third-party assessment in the CE Certificate process, notified body authorisation should be verified through the European Commission’s NANDO database. NANDO identifies conformity assessment bodies notified under EU legislation and their authorised activities. However, inclusion does not mean that a body can assess every product group. Verification should examine the four-digit identification number, relevant legislation, product scope, and procedure together. Third-party certificates offered to manufacturers should be checked to establish whether an authorised body actually issued them. Commercial statements and logos do not replace official authorisation records.

How Is the NANDO Database Searched?

The European Commission’s NANDO notified bodies page may be searched using country, legislation, or body information.

Record details should be opened and the legislation under which the body is notified examined. Similar names in search results should not be treated as definitive matches.

The Four-Digit Notified Body Number

Notified bodies receive a four-digit identification number. It enables matching with the relevant NANDO record.

Where a notified body participates in the production control stage required by legislation, its number accompanies CE marking. The number does not automatically establish authorisation under other legislation.

Verifying Legislation and Product Scope

The directive or regulation under which the body is notified should be identified. Product categories, technical areas, and any limitations should then be checked.

For example, authorisation under machinery legislation should not be assumed to include personal protective equipment.

NANDO Notified Body Checklist

• Number: Verify the four-digit identification number.
• Identity: Compare the body’s name and record information.
• Legislation: Examine notification under the relevant EU act.
• Product: Check that the product is within authorised scope.
• Procedure: Match the required assessment module.
• Status: Verify current notification status and limitations.

Conformity Assessment Procedures and Current Authorisation

Authorisation may be limited to particular procedures. For example, type-examination authorisation may not cover a different production quality assurance procedure.

Notification scope may change, so current records should be checked before proceeding. Written clarification may be requested from the notifying authority or body where uncertain.

Incorrect Third-Party Certificate Claims

The European Commission warns that some bodies offer voluntary certificates that do not constitute valid statutory conformity evidence. These cannot replace mandatory assessment.

KIOSCERT reviews should compare certificate numbers, issuing bodies, and authorised procedures. The manufacturer’s EU declaration and technical evidence should also be assessed where documents are suspicious.

How Are Documents Issued by a Notified Body Assessed?

The legal nature of documents presented as a CE Certificate cannot be determined solely from the word “certificate” on them. Notified bodies may issue different documents according to their authorised conformity assessment procedures. An EU-type examination certificate may demonstrate completion of a particular stage, but does not always mean that the product can immediately be marketed. Product identity, manufacturer details, applicable legislation, assessment method, and remaining stages should therefore be checked together.

What Does an EU-Type Examination Certificate Mean?

EU-type examination assesses conformity of a representative product design or type where prescribed by legislation. A notified body issues the certificate following a satisfactory outcome.

Production conformity may require separate verification afterwards. For example, certain personal protective equipment requires another assessment stage after type examination.

Product and Manufacturer Information

Manufacturer name, address, product model, type designation, and scope should be compared. A certificate covering another product version may be significant for conformity.

Annexes, variations, and technical limitations should also be examined. The cover page alone should not be used to assume coverage of every model.

Legislation, Modules, and Body Authorisation

The stated directive or regulation should be matched with the procedure applied. Module B covers type examination, while other modules may concern production control or quality assurance.

Authorisation should be assessed against both the scope at issue date and the current notification. Clarification should be requested from the issuer where discrepancies arise.

Notified Body Document Checklist

• Manufacturer: Compare name and address details.
• Product: Verify model, type, and scope matches.
• Legislation: Check the relevant EU act.
• Procedure: Examine modules and completed stages.
• Validity: Assess dates, annexes, and limitations.
• Declaration: Check the manufacturer’s EU declaration separately.

Validity Periods and Document Limitations

Validity rules depend on product legislation. For example, under Personal Protective Equipment Regulation (EU) 2016/425, a newly issued EU-type examination certificate may not be valid for more than five years.

This is not a general rule for every CE-related document. Renewal conditions, technical changes, and body decisions should be examined separately.

Voluntary Certificates and the EU Declaration of Conformity

The European Commission warns against voluntary certificates presented as substitutes for statutory assessments. Except where specifically recognised by sector legislation, such documents do not constitute legal conformity evidence.

After completing required assessments, manufacturers issue the EU declaration under their own responsibility. KIOSCERT reviews should distinguish the legal functions of third-party documents and manufacturer declarations.

What Are Common Mistakes When Selecting a Notified Body?

Selecting an unsuitable notified body during the CE Certificate process may create unnecessary costs, incomplete conformity procedures, and delays in EU market entry. Problems often arise from insufficient investigation of product legislation or misinterpretation of third-party documents. The European Commission explains that manufacturers are responsible for identifying applicable legislation and required procedures. Selection should therefore consider more than price, certificate samples, or turnaround time. Correct assessment should begin with product classification and be supported by consistent technical documentation.

Selecting the Wrong EU Product Legislation

Similar-looking products may fall under different legislation because of intended use or technical characteristics. Applications made before scope is established may lead to unsuitable assessment methods.

Multiple acts may apply. Scope, exclusions, and application conditions should be examined separately for each.

Working with a Body Outside Its Authorised Scope

A NANDO listing does not establish authority to assess every product. Notification must cover the relevant legislation, product category, and procedure.

Commercial service lists should not be confused with official notification scope. Authorisation should be verified before application.

Misusing Voluntary Certificates

Voluntary certificates do not replace mandatory notified body assessment. The Commission warns against unregulated certificates presented as legal conformity evidence.

The legal basis and completed assessment should be examined rather than the document title alone. Specific statutory exceptions should also be checked.

Notified Body Selection Checklist

• Legislation: Verify applicable acts.
• Scope: Examine product-category authorisation.
• Module: Match the required procedure.
• Certificate: Investigate voluntary documents’ legal nature.
• File: Check completeness of technical evidence.
• Declaration: Verify EU declaration information.

Identifying the Wrong Assessment Module

Type examination, production control, and quality assurance may impose different obligations. Completion of one stage does not establish completion of other mandatory stages.

Required modules and their sequence should be clarified before application. Manufacturer responsibilities should be documented separately.

Technical File and Declaration Deficiencies

Missing risk assessments, test reports, or product descriptions may leave evidence insufficient despite a certificate. The technical file should identify the assessed version accurately.

Legislation and manufacturer details in the declaration should remain current. Notified body participation does not remove manufacturer liability.

Misinterpreting Document Scope

A document issued for one model does not automatically cover an entire product family. Annex variations, limitations, and change conditions should be examined.

KIOSCERT assessments should compare product identity, body authorisation, and the technical file together. Scope should not be assumed broader until discrepancies are resolved.

How Is the Correct Conformity Assessment Route Determined for CE Marking?

Determining the correct route in the CE Certificate process involves matching technical characteristics with applicable EU legislation. Manufacturers must demonstrate compliance from design through market placement. Intended use, risk category, and prescribed procedures should be considered together. Manufacturer assessment may suffice for some products, while certain categories require notified body involvement. Documents obtained without making this distinction may not establish completion of all market-placement obligations. Decisions should rely on verifiable technical records and current legislation.

Product Definition and Applicable Legislation

First, define function, operating environment, target users, and technical limitations. Relevant directives and regulations should then be identified.

Products subject to multiple acts must meet their requirements together. Exclusions and transitional provisions should be examined separately.

Risk Classification and Assessment Procedure

Where legislation defines risk categories, classification should follow its definitions and rules. Risk level may directly affect procedures for certain product groups.

Available modules should be identified from the relevant act. Self-assessment should be used only where permitted.

Verifying Notified Body Requirements

Where third-party involvement is mandatory, authorisation for the legislation, product category, and procedure should be verified through NANDO.

Product models and stages to be assessed should be clearly identified. Documents issued outside authorisation should not replace mandatory assessment.

CE Conformity Assessment Checklist

• Definition: Record intended use and technical characteristics.
• Legislation: Identify applicable EU acts.
• Procedure: Verify risk class and assessment method.
• Authority: Check the required notified body through NANDO.
• Documentation: Complete the technical file and declaration.
• Monitoring: Track product and legislative changes.

The Technical File and EU Declaration of Conformity

The file should include product description, risk assessment, applied standards, and conformity evidence. Relevant test reports and notified body documents should be included where required.

The manufacturer issues the declaration once assessment is complete. Signing it signifies acceptance of responsibility for compliance with applicable legislation.

CE Marking and Legislative Monitoring

CE marking should follow the applicable format and placement rules after assessments are completed. The notified body’s number accompanies it where legislation requires.

Design changes, updated standards, and new legislation should be monitored. KIOSCERT conformity procedures should check current files and declarations while observing statutory retention periods.