CE Mark · European conformity
CE Marking: A Guide to European Conformity
A guide to the European conformity marking for manufacturers and exporters, and the role of quality-system certification in it.
Overview
What is the CE mark?
CE marking is the manufacturer's declaration that a product meets the applicable European Union legislation (directives and regulations) on safety, health and environmental protection. The manufacturer affixes the mark to the product. It is a condition for placing products covered by that legislation on the European Economic Area market, not a quality certificate awarded by a third party.
Conformity is shown in one of two ways. For many products, the manufacturer self-declares conformity after building a technical file and drawing up an EU Declaration of Conformity. For higher-risk categories, such as many medical devices, pressure equipment, some machinery and personal protective equipment, an EU Notified Body must take part, and it issues the relevant certificate.
Team Quality is not a Notified Body. We do not issue CE certificates or prepare technical files, but we certify the quality management systems that many CE conformity routes rely on: ISO 9001, and ISO 13485 for medical devices. These certificates support the manufacturer's quality assurance and documentation, but they are not a CE certificate and do not replace a Notified Body where one is required.
What CE marking means
The manufacturer's declaration that the product meets the EU legislation that applies to it, affixed by the manufacturer itself.
How conformity is shown
Self-declaration with a technical file and EU Declaration of Conformity for many products; a Notified Body takes part for higher-risk categories.
What it does for exporters
It allows products covered by EU legislation to circulate freely within the European Economic Area.
The role of QMS certification
ISO 9001 or ISO 13485 certification from Team Quality supports production control and documentation, but it is not a CE certificate.
What does CE marking give your organisation?
What CE marking does for an exporter, and how a certified ISO 9001 or ISO 13485 system supports it.
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Access to the European market
CE marking lets you place products covered by EU legislation on the market and sell them freely across the European Economic Area, one of the largest markets in the world.
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Trust and recognition
It confirms to customers and distributors that the product meets the essential requirements of the EU legislation that applies to it.
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Wider business opportunities
It opens the door to exports and to expanding your business into EU member states and other international markets.
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Legal compliance
It keeps your products in line with European standards and regulations, helping you avoid legal issues and penalties.
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Consistent production control
A certified ISO 9001 or ISO 13485 system helps you control production consistently, so products keep matching the design whose conformity was demonstrated.
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A documented QMS
A documented quality management system provides the procedures and records that the technical file and EU Declaration of Conformity rely on.
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Readiness for a Notified Body audit
A certified quality system leaves your organisation better prepared for a Notified Body assessment where the conformity route requires one.
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Reduced risk
The product risk assessment required by EU legislation helps reduce incidents and problems in the market.
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Keeping up with changes
Following EU legislation and harmonised standards helps you update your product designs when requirements change.
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Business stability
Ongoing commitment to your quality system, with periodic ISO surveillance audits, helps products stay compliant after they reach the market.
Steps to CE marking a product
The route a manufacturer follows from identifying the legislation to affixing the mark, and where QMS certification fits.
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Step 1: Identify the applicable legislation
The manufacturer identifies the EU directives and regulations that apply to its product, such as the machinery, medical device or low voltage legislation.
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Step 2: Identify requirements and harmonised standards
Determine the essential requirements of that legislation and the harmonised European standards that give a presumption of conformity.
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Step 3: Determine the conformity assessment route
The legislation sets the route according to the product's risk category: self-declaration by the manufacturer, or a route that requires a Notified Body.
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Step 4: Build the technical file
The manufacturer compiles the technical file, covering the product description, design, risk assessment and test results, and keeps it available for the authorities.
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Step 5: Notified Body assessment, if required
For higher-risk categories, a Notified Body assesses the product or the quality system and issues the certificate the legislation requires.
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Step 6: Draw up the EU Declaration of Conformity
The manufacturer draws up the EU Declaration of Conformity and, by doing so, takes responsibility for the product's conformity.
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Step 7: Affix the CE mark
The manufacturer affixes the CE mark to the product, followed by the Notified Body's identification number where one took part.
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Step 8: Keep a quality management system in place
The manufacturer maintains an effective quality system, monitors the product after it reaches the market and updates the technical file when the product or legislation changes.
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Step 9: Team Quality's role
Team Quality can certify the supporting ISO 9001 or ISO 13485 quality management system. This is a management-system certificate, not a CE certificate.
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CE marking FAQs
What is CE marking and what does it do?
CE marking is the manufacturer's declaration that a product meets the requirements of the EU legislation that applies to it. It is a condition for placing those products on the market and selling them freely across the European Economic Area.
Do all products exported to Europe need CE marking?
No. Only products covered by EU legislation that requires CE marking, such as machinery, electrical equipment, medical devices, personal protective equipment and toys. The mark must not be affixed to products outside that legislation.
What requirements must a product meet to carry the CE mark?
It must meet the essential requirements set out in the EU legislation that applies to it. This is usually shown by applying harmonised European standards and compiling a technical file.
Who affixes the CE mark?
The manufacturer (or its authorised representative in the EU) affixes the mark, draws up the EU Declaration of Conformity and takes responsibility for the product's conformity.
What is the role of a Notified Body?
A Notified Body is designated by an EU member state to assess the conformity of higher-risk products, and it issues the certificate required on those routes. It is not needed for products where self-declaration by the manufacturer is allowed.
How can I check the CE marking on a product I buy?
Ask the supplier for the EU Declaration of Conformity. If a Notified Body took part, check its four-digit number in the European Commission's NANDO database.
Does Team Quality issue CE certificates?
No. Where a Notified Body is required, it issues the certificate; we certify ISO 9001 and ISO 13485 quality management systems.
How does ISO 9001 or ISO 13485 certification help on the CE route?
Many conformity routes rely on an effective quality system, especially for medical devices. Accredited system certification supports the manufacturer's production control and documentation, but it is not a CE certificate and does not replace a Notified Body assessment where one is required.
What is the difference between CE marking and ISO certification?
CE marking concerns a product's conformity with EU legislation and is mandatory for the products it covers. ISO certification, such as ISO 9001, concerns an organisation's management system; it is voluntary and is issued by an accredited certification body.
Does CE marking expire?
The mark itself does not expire, but the manufacturer must update the technical file and Declaration of Conformity when the product or legislation changes. Notified Body certificates, where required, have a fixed validity and are subject to surveillance and renewal.