Register/Notify your MDD-Medical Devices and IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking Specialists based in London/UK. Click here to get FREE Guide Now!

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How affect export to Europe ? Your Ad Here How does CE Marking affect the export to Europe? If the new product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking will be crucial to your success. It is NOT unusual nowadays that non-EU manufacturers and exporters have had their product(s) seized by customs officials in the European Union at the worst or returned to them because they do not have the CE marking affixed to the product(s). The CE Marking can be, at the same time, of both benefits and disadvantages. Benefits: With this "passport" your products can easily gain access to the entire European Union (EU) plus European Free Trade Association (EFTA) market. There will be only one set of laws and regulations for the entire marketplace which guide the designing, manufacturing and labeling of products. The multiple and conflicting national restrictions on regulated products will be eliminated. Thus the CE Marking on your product will make your trade with EU countries cheaper and easier. Your product will be made safer for consumers and thus the damage claims and liability premiums will be reduced. Disadvantages: New product directives may exceed the current national laws and regulations. It may cost a manufacturer extra to modify the currently existed design and/or production line in order to continue exporting to or gain access to this huge European market. Extra costs in obtaining the product Certificate of Registration for CE Marking and any, if applicable, required testing certification. back to top of this page 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   | home/first page | back to where you were | back one page | top of this page | next page |