CE Marking for my product.
How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product?
There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents:
- Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
Module A: internal production control
Module Aa: intervention of a Notified Body
Module B: EC type-examination
Module C: conformity to type
Module D: production quality assurance
Module E: product quality assurance
Module F: product verification
Module G: unit verification
Module H: full quality assurance
Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.
Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union. Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.
A Notified Body is usually able to offer some of the services required:
- product testing
- type examination certificate issue
- Technical File and design dossier evaluation
- surveillance of product and quality system
- identification of standards
- If your products need to be certified by a Notified Body, then you will need to do as the follows:
Some directives require that a manufacturer designate in the European Union an authorized representative to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so. The CE Marking itself is not meant to provide details about the product to Surveillance Authorities. Technical Documentation (Technical File): The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.
Many products, for instance, Class I Medical Devices, are required to be registered in the EU and, if proved, get a Certificate of Registration. Without this Certificate of Registration, the products are NOT allowed to be affixed with the CE Marking and be placed on the market.
There are specific rules to adhere to for the CE Marking. These rules address the size and location of the Marking; affixing the CE Marking to products, packaging and material or documents shipped with the product; and specific limitations on when and who is permitted to affix the CE Marking.
Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-
- Does my product need CE Marking in order to be sold/exported on/to the European Market?
- How to obtain CE Marking for my product?
- How can Wellkang Consultant Firm help me to obtain CE Marking for my product?
- Wellkang can
be your Authorized Representative in Europe for CE Marking purpose !
- Buy a Directive or Guideline on Directive in Chinese, English, French, Portuguese and/or Spanish.
- Complete list of all CE Marking Directives and Guidelines to Directives
Complete list of all (more than 1000) Notified Bodies for CE marking
Complete list of all European and/or international standards related to CE marking
- 85/374/eec: Directive of Liability for Defective Products (for all products)
- 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
- 2000: (Proposal for a new ) General Products Safety Directive (for all products)
- 92/59/eec: Directive of General Products Safety (for all products)
- 93/68/eec: "CE Marking" Directive (for all products)
- 93/465/eec: Conformity Assessment Procedures & CE Marking Rules. & Annex (for all products)
- Guide to Implementation of directives based on new approach & global approach (for all products)
- 73/23/eec: Directive of Low Voltage Electrical Equipment
- Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
- 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
- 87/404/eec: Directive of Simple Pressure Vessels
- 88/378/eec: Directive of Toys & Annex I, II. IV
- 2001 Framework of implementation of 88/378/eec: Directive of Toys
- 89/106/eec: Directive of Construction Products
- 2001 Guidance to 89/106/eec Directive of Construction Products
- 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
- Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
- Technical-Aspects relating Directive of Electromagnetic Compatibility (EMC) 89/336/eec
- Communication 2000 in framework of implementation of EMC Directive 89/336/EEC
- 89/686/eec: Directive of Personal Protective Equipment (PPE)
- Useful Facts relating to Directive (PPE) 89/686/eec
- 2001 Framework of implementation of (PPE) Directive 89/686/eec
- 90/384/eec: Directive of Non-automatic Weighing Instruments
- 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas)
- 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec
- 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers
- 93/15/eec: Directive of Explosives for Civil Uses
- 93/42/eec: Directive of Medical Devices
- 2001 Guidelines for Classification of Medical Devices
- Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
- 90/385/eec: Directive of Active Implantable Medical Devices
- 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
- Guidelines to Medical Devices Vigilance System
List of Harmonised (European) Standards for Medical Devices
List of Notified Bodies for Medical Devices Directive
Guidelines for Conformity Assessment of Breast Implants According to Directive 93/42/eec
Guidelines on Assessment of Medical Devices Incorporating Materials of Animal Origin
Guidelines on Medical Devices With Measuring Function
Guidelines on Medical Devices: Subcontracting – Quality System Related
Guidelines on Medical Devices: Treatment of Computers Used to Program Implantable Pulse Generators
Guidelines on Medical Devices: Demarcation with other Directives- Directive 89/336/EEC EMC & Directive 89/686/EEC PPE
Guidelines on Medical Devices: EMC Requirements
Guidelines on Medical Devices Labelling: USE-BY DATE
Guidelines on Medical Devices Labelling: Translation procedures
Guidelines on Homogeneous Production Batches
- 93/65/eec: Directive of Air Traffic Management Equipment & Systems
- 97/15/eec: amending Directive of Air Traffic Management Equipment & Systems
- 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex)
- Guidelines to directive 94/9/ec (Atex)
- 2001 Framework of implementation of (Atex)Directive 94/9/ec
- 94/25/ec: Directive of Recreational Craft
- 2001 Proposed New Version for: directive 94/25/ec (RecCraft) 55p
- 2001 Guidelines&Framework. directive 94/25/ec (RecCraft)
- 95/16/ec: Directive of Lifts
- 96/48/ec: Directive of Trans-European High-speed Rail System
- 2001/16/ec: Directive of Interoperability of Trans-European Conventional Rail System
- 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
- 96/98/ec: Directive of Marine Equipment
- 97/23/ec: Directive of Pressure Equipment
- 2000&2001 Framework. directive 97/23/ec Pressure Equipment
- 98/37/ec: Directive of Machinery
- 2000: Comments on Directive of Machinery 98/37/ec
- Useful Facts relating to Machinery 98/37/ec
- 2001 Proposal to amend Directive of Machinery 98/37/ec
- 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
- 2001 Framework of implementation of Directive 99/5/EC R&TTE
- 2001 Guidance on Directive 99/5/EC R&TTE
- 2000/9/ec: Directive of Cableway Installations to Carry Persons
- 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Canada
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Australia
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and Israel
- 2001 proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan