- CE Marking is not an option, it is a law in Europe.
- The law is based on mandatory European Directives adopted and enforced in all member countries of the European Union (EU).
- A product that is not CE Marked is automatically considered to be non-compliant.
- The law is enforced through market surveillance by appointed national enforcement agencies. Imported products are checked for compliance at customs offices.
- Businesses selling products in Europe include CE Marking requirements in their purchasing contracts.
The CE Marking
- Is a marking that is affixed on the product by the manufacturer.
- Is a legally binding statement by the manufacturer that the product meets the relevant requirements of all the applicable Directives.
- Is not a certification or approval mark issued by a third Party.
- Allows entry and free movement of the product in the European market.
Cost of Non-Compliance
- The product can be stopped at customs and prevented from entering Europe.
- If previously placed on the market, the product can be withdrawn.
- Could result in prosecution and fine.
- Could result in loss of good reputation and bad publicity for the manufacturer.
- Determine which Directives apply.
- Comply with the requirements of all applicable directives.
- Issue a Declaration of Conformity (DOC).
- Affix the CE Marking on conforming products.
- Maintain the required documentation as evidence of compliance.
What is a Directive?
- A Directive is a European law that is binding for, and enforced by every Member State as a National Law.
- Directives contain requirements that the manufacturer must comply with, for the product to be allowed access in the internal market of member countries.
Essential Requirements and Standards
- Each Directive contains a set of “Essential Safety/Protection Requirements” that are mandatory to comply with.
- Directives specify “what” is required and “why”, but not “how” to comply.
- Standards show “how” to comply, but are voluntary.
- Compliance with appropriate harmonized European Norms (EN) – Standards – presumes compliance with the essential requirements of the Directive in question.
Directives – Examples
- Low Voltage Directive: a horizontal directive that applies to all electrical products.
- Electromagnetic Compatibility Directive.
- Machinery Directive.
- ATEX Directive (for products used in explosive atmospheres).
- Medical Device Directive.
- Simple Pressure Vessels Directive.
- Pressure Equipment.
- RoHS(Restriction on the use of Hazardous Substances)Directive.
- WEEE (Waste Electrical and Electronic Equipment) Directive.
- Compliance with the “Essential Requirements” of a Directive can be achieved in several different ways.
- For most products, third-party certification is not mandatory, and the manufacturer is allowed to self-declare conformity with the relevant Directives.
- The various methods of compliance available to manufacturers are outlined in each particular Directive, and are known as “Conformity Assessment Modules”.
- Depending on the type of product and the associated hazards, it may be necessary to involve a European third-party Certification Body to carry out what is known as EC Type testing and examination, or to check the quality system.
- European Certification Bodies or Test Houses are commonly referred to as “Notified Bodies”.
- European Notified Bodies may contract out testing and evaluation work to other non-European Certification/Testing Organizations (such as QPS).
Conformity Assessment Modules
- Module A: Self declaration, with internal production control.
- Module Aa1 and Aa2: Self declaration, with limited involvement by a Notified Body.
- Module B: Type examination by a Notified Body. This Module may not be used alone to CE mark a product.
It must be used in combination with module C, D, E or F.
- Module C: Declaration of conformity to type.
- Module D: Production Quality Assurance (EN 29002/ISO 9002).
- Module E: Product Quality Assurance (EN 29003/ISO 9003).
- Module F: Product Verification.
- Module G: Unit Verification.
- Module H: Full Quality Assurance (EN 29001/ISO 9001).
How Can QPS Help?
Experience and Expertise
- QPS is accredited as a third party National Certification Body.
- Each of our experts in conformity assessment standards has a minimum of 15 years of hands-on experience in testing and evaluation to North American (UL/CSA), International (IEC/ISO) and European (EN) standards.
- Our engineering staff participate in many National and International standards committees.
- Being accredited Internationally in the IECEE/CB Scheme and the IECEx Scheme, QPS can issue Test Reports and Certificates that are accepted as part of the “Technical File” required under the European Directives.
We Offer a Full Complement of CE Marking Services…
Our customers can select any one, or a combination of the following services:
- Provide overall consultation on all matters related to the Directives and the CE Marking.
- Assist in identifying the applicable Directives and European Harmonized Standards (EN standards).
- Provide guidance on product design, and training on the application and interpretation of the requirements of the Directives and Standards.
- Conduct Risk Assessment as required by some Directives, including identifying the hazards involved and proposing solutions to eliminate/reduce them.
- Perform the required testing and evaluation of the product to the relevant Directives and Standards. Such testing can be conducted either on site or at our labs.
- Provide complete test and evaluation reports to support manufacturer’s self-declaration of conformity.
- Obtain Notified Bodies certificates, where required.
- Assist in preparing the relevant mandatory documentation (e.g. Technical Files/Dossiers, User Manual, Declaration of Conformity, etc.) required by the Directives.
- Provide “Component Compliance Service”: We will identify “Critical Safety Components/Parts” used in the product that require conformity approval, and will assist in sourcing of such components to ensure overall compliance of the product.