Testing for CE marking

What is CE marking?

This regulatory marking indicates that the manufacturer is responsible for compliance with the essential requirements of the product set by European Union legislation. It thus allows it to be placed on the market and free to move within the European Union.

Key takeaways include:

• Visible commitment from the manufacturer that its product meets regulatory requirements
• Visual symbol of compliance
• Mandatory marking when products falling within the scope of a European directive or regulation are placed on the European market
• It is an indication, but in no way a proof, nor a certification mark, nor an indication of the origin of the product or a marketing tool

Objectives of the CE marking and products concerned

The main objectives are:

• Authorising the placing on the market and circulation of the product within the single market
• Ensuring that only safe and compliant products are placed on the market
• To allow the identification of the person responsible in  case of accident

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The conditions for its affixing are as follows:

• Affixing the product or its nameplate in a visible, legible and indelible manner
• Affixing to the packaging and/or accompanying documents, if the product does not allow it
• Minimum marking height of 5 mm and retention of proportions in case of reduction or enlargement
• Affixing by one of the economic operators (manufacturer, authorised representative, importer, distributor)
• Electronic labelling is not permitted.

Which products are concerned?

All products covered by one or more of the EC directives or regulations must affix the CE marking. It is up to manufacturers, agents, importers or distributors to take the necessary steps to affix the CE marking before they are placed on the European market.

What steps to apply the CE mark

To affix the CE marking to a product, it is necessary to know and identify, from the design stage, the requirements applicable to the product (directives, regulations, harmonised standards, etc.) and to determine whether an independent conformity assessment by a notified body is necessary.

The manufacturer calls on a Notified Body (NB) when he needs to issue a certificate of the product's compliance with essential requirements.

For products in the medical sector, GMED, a subsidiary of LNE, in its capacity as a notified body, identification number CE 0459, offers certification services to meet the requirements of the applicable directives.

Questions to ask yourself:

• Do one or more of the EC Directives and Regulations govern my product?
• What tests should be carried out?
• Are there applicable harmonised standards covering the essential requirements of the Directive?
• Do I need to use a notified body?

In all cases, it will be necessary to obtain a test report issued by a competent laboratory such as LNE and, depending on the case, to have the conformity assessment carried out in addition by a notified body.

Tests to be carried out according to the applicable guidelines

To bring products into compliance with the regulations in force with a view to their placing on the market, LNE offers a range of services with a multi-business and multi-skill approach (testing, certification, metrology, technical and regulatory assistance, etc.), its teams of experts and its state-of-the-art equipment.

• Electromagnetic compatibility (EMC) tests ensure the proper functioning of electrical and electronic products in their electromagnetic environment while ensuring that they themselves do not disturb it, and thus meet the regulatory requirements in force (European directives EMC, RED, Medical, MID, etc.).
• Radio frequency tests allow products using radio frequencies to check their transmission power, spectral occupancy, the presence of parasitic emissions as well as their reception sensitivity and thus meet the essential requirements set out in the RED Directive 2014/53/EU for CE marking or in the various international certifications (FCC, ISED, MIC/Giteki, … ).
• Safety tests of electrical and electronic products make it possible to meet normative requirements within the framework of European directives (Medical Devices, Low Voltage, Machinery Directive, etc.), in order to guarantee the safety of goods and people with regard to electrical, mechanical, thermal and fire risks.
• Tests of the performance and suitability for use of insulating materials to characterise building insulation products (insulating materials and insulating glazing, etc.) within the framework of CE marking (products covered by the CPR construction products regulation) or a specific customer request.
• Tests on medical devices and in vitro diagnostic medical devices make it possible to validate their safety in order to meet certain requirements of European Regulations 2017/745 and 746 applicable since May 26, 2021, to demonstrate their compliance and to evaluate their performance before they are placed on the market, in order to obtain CE Marking or other certifications such as the CB Scheme.
• Services concerning construction products make it possible to meet all the challenges of building and construction products professionals (quality products, compliance, performance, cost control, sustainable development, etc.).

CE marking, directive, harmonised standard, notified body... Some definitions

What is a directive?

A directive is a legislative instrument used by the European Union to take action. It imposes on the recipient States a common objective and a deadline for achieving it. Directives are adopted, through a vote, by the European institutions based on the Treaties, and must then be transposed by the Member States into their national law, in order to give them the force of law, unlike regulations, which apply directly.

What is a regulation?

Among the legal instruments of the European Union, the Regulation is a legal act of general application, binding in all its provisions. It must be published in the Official Journal of the EU to have binding effects. Its adoption is sometimes imposed, depending on the area, by the treaties. It is directly applicable in the legal systems of the Member States and is binding on all subjects of law: individuals, legal persons, States, institutions.

What are the differences between a regulation and a directive?

Unlike the Regulation, which is applicable in the Member States directly after its entry into force, the Directive is not directly applicable. Once voted on by the European institutions, it must then be transposed by the Member States into their national law to become applicable.

What is a harmonised standard?

Harmonised standards are a special category of European standards.

• They are developed by a European Organisation for Standardisation following a request (mandate) from the European Commission and represent around 20% of European standards.
• They are cited in the European Official Journal for the requirements of the directive they intend to cover.
• They serve to prove that the products or services comply with the technical requirements of the relevant European legislation.
• They establish technical specifications that are considered to be suitable or sufficient to comply with the technical requirements of European legislation.

What is a Notified Body?

A Notified Body (NB) is an organisation appointed by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before they are placed on the market.

It helps the manufacturer determine if their product meets certain standards. The compliance audit can focus on the inspection and control of a product, its design, its production environment and related processes.

The manufacturer calls on a Notified Body (NB) when he needs to issue a certificate of the product's compliance with essential requirements.

What is an essential requirement?

An essential requirement is a condition that must be met for a product, service or activity to be considered compliant. These requirements concern safety, health, the environment or consumer protection.

In the context of products, European directives and regulations define the essential requirements.

Who are the actors concerned by the CE marking?

• Manufacturer: any natural or legal person who manufactures a product or has a product designed or manufactured and markets this product under its own name or brand
• Authorised representative: any natural or legal person established in the Union who has received a written mandate from the manufacturer to act on his behalf for carrying out specific tasks. He can be an importer or a distributor and in this case he assumes both roles.
• Importer: any natural or legal person established in the Union who places a product from a third country on the Union market.
• Distributor: any natural or legal person, other than the manufacturer or importer, who makes a product available on the market

Learn more

CE marking file

Consult the "CE marking" file on the portal of the Directorate-General for Enterprise of the Ministry of the Economy, Finance and Industrial and Digital Sovereignty, with in particular the list of applicable directives.

list OF APPLICABLE DIRECTIVES (in french)

Guide

The guide "CE marking and directives on the safety of products placed on the EU market" is one of the main reference explanatory documents regarding the implementation of the legislation now covered by the new legislative framework (NLF). It is intended for companies wishing to make non-food products available to consumers in Europe.

DOWNLOAD THe guide

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