About CE Marking
CE marking indicates that a product placed on the market in the European Economic Area complies with the applicable European Union health, safety and environmental protection legislation. It is required for product categories covered by EU directives and regulations such as those for machinery, low-voltage equipment, electromagnetic compatibility, pressure equipment, medical devices, personal protective equipment, toys and construction products.
CE marking is not an ISO certification. It is a product-conformity declaration made by the manufacturer (or, in defined cases, an authorised representative or importer). The applicable requirements and the conformity-assessment route depend on the product and the relevant EU legislation; some routes allow manufacturer self-declaration, while others require the involvement of an EU Notified Body.
Innovative Quality Consultancy helps manufacturers and exporters understand what applies to their products, prepare the required technical documentation and establish the production controls that keep products in conformity.
Key elements of the CE marking process
- Identification of the EU directives and regulations applicable to the product and its intended use.
- Determination of the conformity-assessment route (module) specified by the legislation, including whether a Notified Body is required.
- Identification of essential health and safety requirements and relevant harmonised European standards.
- Product risk assessment and design or testing measures to meet essential requirements.
- Compilation of the technical documentation (technical file): product description, drawings, risk assessment, test reports, applied standards, instructions and labelling.
- EU Declaration of Conformity, affixing of the CE marking and, where required, the Notified Body number.
- Production quality controls, traceability and procedures to maintain conformity for series production.
Suitable organizations
- Manufacturers of machinery, electrical and electronic equipment, pumps, motors, valves and pressure equipment exporting to Europe.
- Medical device, PPE, toy and construction product manufacturers subject to EU product legislation.
- Exporters and contract manufacturers whose European customers require CE-marked products and technical documentation.
Business benefits
- Clear understanding of the legislation and conformity route that applies to your product.
- Technical documentation structured to withstand customer, authority and Notified Body scrutiny.
- Access to the European market and to customers who require CE-marked products.
- Reduced risk of non-compliant shipments, market surveillance action and product withdrawal.
- Production controls that maintain conformity after initial assessment.
How Innovative Quality Consultancy supports you
Innovative Quality Consultancy supports your organization through every stage of implementation:
- Applicability review: which EU directives, regulations and harmonised standards apply to your product.
- Guidance on the appropriate conformity-assessment route and Notified Body involvement where required.
- Risk assessment facilitation and technical file compilation support.
- Preparation of the EU Declaration of Conformity, labelling and user information requirements.
- Production control procedures, records and internal audits to maintain conformity.
- Coordination support for testing laboratories and Notified Bodies where third-party assessment is required.
CE marking is a declaration of conformity with EU product legislation, not an ISO management system certification. Where a Notified Body is required, that body conducts the assessment and issues its certificate independently. Innovative Quality Consultancy does not issue CE certificates or guarantee acceptance.
Discuss CE Marking for your organization
Tell us about your products, processes and timeline and we will outline a practical implementation plan.
Enquire about CE Marking