- 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 Mark
- 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- If previously placed on the market, the product can be withdrawn.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.
The QPS CE Marking Program is designed to build confidence into your declaration, and will be tailored around your needs. It can be conducted at one of our locations or at your facility.