CE  MARKING

Products without CE marking will not be accepted for sales within European market.

The European legislation requires manufacturers to display CE Marking on their product, packaging and accompanying literature.

CE Marking as a “Passaport” which allows products to be freely circulated within the E.U. single market.

Consumers will consider CE Marking on a product as an indication of conformance to lay down minimum standards, and therefore a minimum level of quality, which other products may lack.

CE marking is thus for many consumers a “Symbol of Quality”.

CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called product Directives, which contains the “essential requirements” and / or “performance levels”, and “harmonized Standards” to which the products must conform.

CE Marking Directives require that manufacturers and exporters must be represented in Europe and / or maintain a copy of their Technical File in Europe.

The most practical ways CE Marking may be achieved, which is preferred by many EU importers who are neither specialized in the complicated CE Marking process nor willing to take risk, is that the manufacturer designates an Authorized  Representative in the EU member states who will take care of the CE Marking issue therefore the importers and/or distributors can focus on the marketing and sales of the products.

The manufacturer may need only one Authorized Representative in EU whereas may have many importers and/or distributors.

The Authorized Representative may in some cases register the product(s) in the EU member states and thus obtain a Certificate of Registration.

The Product Certificate of Registration for CE Marking obtained from one EU member state is valid for the  entire EU Market 

In general, CE Marking is required if you want to sell, the following 23 groups of products :
air traffic management equipment & systems, appliances burning gaseous fuels, cableway installations to carry persons, construction products, electrical equipment, equipment and protective systems for explosive atmospheres, explosives for civil uses, hot water boilers, household refrigerators & freezers, lift, machinery, marine equipment, measuring instruments, medical devices, active implantable medical devices, in vitro diagnostic medical devices, non-automatic weighing equipment, personal protective equipment, pressure equipment, simple pressure vessels, recreational craft, radio equipment & telecommunications terminal equipment, toys and trans-European conventional rail system

It is therefore recommended that manufacturers and exporters appoint a third party to act as their Authorized Representative that is not commercially involved in the sale of its products. But acts solely as its regulatory .

An Authorized (Authorised) Representative is the one who will represent the manufacturer to deal with the CE Marking vigilance authorities  . This is somehow similar to that you may need a lawyer representing you in the court.

A non-EU manufacturer needs only one Authorized Representative in the entire European Union whereas may have many distributors and/or sales agents. Most of the importers/distributors are skilled in marketing and sales, but not familiar with the complicated CE Marking issues.

It is required by the EU legislation that a non-EU manufacturer must print its EU Authorised Representative´s name, address & contacting details on the packaging/labelling of the product(s) sold onto the EU & EFTA market.

The authorities from any of the   EU & EFTA Member States may call the Authorized Representative up for CE Marking vigilance at any time and the Authorized Representative must respond immediately and properly within the permitted time.

Through it’s associated partners,  COMPODYNAMIC offers manufacturers and traders who do not have a place of business in Europe easy access to required Authorized Representative status.

Then you will appreciate the service  COMPODYNAMIC offers to exporters who sell to Europe: you can focus fully on your business opportunities by knowing that all pre-market and post-market regulatory issues in Europe are taken care of professionally by  COMPODYNAMIC experts.

How can  COMPODYNAMIC  help you ?

 COMPODYNAMIC  provide a comprehensive range of business services aimed at assuring the European product conformity. The in-depth expertise of our professionals and an extensive working experience in a wide industrial spectrum enable us to achieve this goal. COMPODYNAMIC strives to establish a close, trusting relationship with our clients based on proven performance and total dedication to their products.

1. Technical Consulting Service

o       Technical Advice on Compliance Engineering

o       Safety and Risk Assessments

2. Compliance Testing Service

o       Pre-compliance testing arrangement

o       Full-compliance testing arrangement

3. Technical Documentation Service

o       Technical Files (Technical Documentation):
guiding you preparing this document.

o       EC Declaration of Conformity:
guiding you preparing this document, we have different models in several languages

4. EU Documentation and Standards Delivery Service.

o       EU Product Directives

o       European Standards

o       EU Official Documents

Labeling and Document Translation
(We can arrange the translation from English into the official language(s) of every EU member state)

o        Users Manual and Installation Instructions

o        Labeling Advice and Translation

EU Authorized Representative Service

o       Product Registration:
We can register your product in EU for the first time and get your product a Certificate of Registration  . With this Certificate, your product will be qualified for and obliged to affixing the CE Marking, the so-called "Passport To Europe".

o       Renewal and Update Product Registration:
The product Certificate of Registration is valid for one year only and must be renewed annually. The information about the product must be updated whenever it changes and at least once a year when renew the product Certificate of Registration.

o       Keep Your Technical Files:
We store and update the Technical Files of your products sold in Europe, and makes them available timely to the appropriate surveillance/vigilance authorities upon request.

o       Legislation Monitoring:
We monitor and report on new developments in European product legislation relevant to your products.

o       Vigilance and Incident Reporting:
We assist with product vigilance and incident reporting.

o       Product Recalls and Advisory Notices:
We assist with Product Recalls and the issuing of Advisory Notices

How can you benefit by designating  COMPODYNAMIC as your EU Authorized Representative?

1.  COMPODYNAMIC offers you a foothold in Europe: a name, an address, a telephone and fax number and a Web address. Save you the cost of opening an office in Europe.
2. COMPODYNAMIC acts as the contact person for market surveillance authorities and end users when conformity issues are concerned.
3.  COMPODYNAMIC  stores and updates the technical files of the products sold in Europe, and makes them available to the appropriate authorities upon request.
4. COMPODYNAMIC  registers your products with the appropriate authorities. 
5. COMPODYNAMIC provides advice on the implementation of European technical regulations and guides clients through the certification procedures.
6.  COMPODYNAMIC monitors and reports on new developments in European product legislation relevant to clients.
7.  COMPODYNAMIC offers product vigilance and incident reporting.
8. COMPODYNAMIC assists with product recalls and the issuing of advisory notices
9. COMPODYNAMIC annual fee is fixed and includes all services; no additional hourly rates are charged.
10. Keep your business secrets confidential: it is  COMPODYNAMIC and not the European distributor(s) who keeps the technical files.
11.  COMPODYNAMIC  will register/provide you with a  FREE internet domain name,  and  FREE email address with your chosen domain name,  and a FREE  web hosting of a 6-page website .

How much does it cost ? Competitive Prices !

 COMPODYNAMIC charges for Authorized Representative Service an annual fee. Below are the fees for several classes of products:   

1. Authorized Representative Service for Class I, Class IIa & Class IIb Medical Devices:
• Annual Fee for 1st year (12-month period)
• 800 EURO for the first 3 models * of same product, (first time registration, including Registration Fee charged by the authorities)
• 100  EURO each for additional similar models or products for registration in the same time.
  
  * A model of a product is normally identified by a unique article number (or corresponding alphanumeric code) and corresponds to one row in a price list.
• Annual Fee beginning 2nd year
• 400 EURO for the first 3 models of same product, (including the annual renew fee of the Product Certificate of Registration)
• 50  EURO/each for additional models or products.
2. Authorized Representative Service for Personal Protective Equipment:
• Annual Fee for 1st year (12-month period)
• 400 EURO for the first 3 models of same product.
• 50 EURO/each for additional similar models.
• Annual Fee beginning 2nd year
• 150 EURO for the first 3 models of same product.
• 20  EURO/each for additional models or products.
3. Authorized Representative Service for Toys:
• Annual Fee for 1st year (12-month period)
• 150 EURO for the first 3 models of same product.
• 20 EURO/each for additional similar models.
• Annual Fee beginning 2nd year
• 100 EURO for the first 3 models of same product.
• 10  EURO/each for additional models or products.
4. The Annual Fee for products covered by other EU Directives: Low Voltage Electrical Equipment (LVD), Electromagnetic Compatibility (EMC), Machinery, etc. varies greatly from case to case, from product to product.