EU Authorized Representative service

 

Why do you need an EU representative? 

 

Since 16th of July 2021, it is required that manufacturers of products that are located outside of the European Economic Area have a local representative that is located within the European Union. 

This local representative has to be appointed contractually and will have the following obligations:

 

  • Verify that the Declaration of Conformity (DoC)has been drawn up. 
  • Keep the DoC at disposal of the market surveillance authorities.
  • Provide authorities with information and documentation (Technical File) to demonstrate conformity of the product.
  • Inform market surveillance authorities if there is a reason to believe the product presents a risk.
  • Cooperating with market surveillance authorities, including following a reasoned request to take corrective action to remedy a case of non-compliance of a product. 

Which products require EU representative service

The following table shows the Product Directives that require a local European Union representative is contracted: 

  

  •  305/2011  | Construction products
  •  2016/425  | Personal Protective Equipment
  •  2016/426  | Appliances burning gaseous fuels
  •  2000/14    | Noise emission by equipment for use outdoors
  •  2006/42    | Machinery
  •  2009/48    | Toys
  •  2009/125  | Ecodesign for energy related products
  •  2011/65    | Restriction of Hazardous substances in electrical and electronic Equipment (RoHS)
  •  2013/29    | Pyrotechnic articles
  •  2013/53    | Recreational craft and personal watercraft
  •  2014/29    | Simple Pressure Vessels
  •  2014/30    | Electromagnetic Compatibility
  •  2014/31    | non automatic weighing instruments
  •  2014/32    | measuring instruments
  •  2014/34    | Atex
  •  2014/35    | Low Voltage products
  •  2014/53    | Radio Equipment
  •  2014/68    | Pressure Equipment

What Certanex offers

If you have a local business partner, such as a local branch offices, a sales agent, or a cooperative importer for instance, you might not need an independent specialised agency to act as your local European representative. 

 
If you do not have these options available to you, you can call on Certanex to provide these services: 

  • Review of your Declaration of Conformity, to ensure it is compliant with regulations
  • Review of completeness of Technical File (high-level), to ensure elements that might be requested by authorities are present 
  • Secure storage of Declaration of Conformity, Technical File, other documents and information, so confidentiality will be guaranteed. 
  • Storage for 10 years of technical file, DoC and additional documentation.
  • As your Authorised Representative, we will provide you with our name and contact details, for you to place on the product, it’s packaging or accompanying documentation.

Additional advantages offered by our services

 

  • Non-Disclosure Agreement* and confidentiality agreement with the manufacturer to ensure Intellectual Property will not be at risk. 
  • We act in your best interest when decisions may need to go against the interests of an importer/distributor 
  • Storing your files with Certanex will keep design and manufacture documentation out of the hands of importers and distributors. 
  • We respond to requests from authorities promptly and effectively while distributors and company branch offices may have other priorities. 
  • If a risk is identified, we will liaise with you and support you in taking immediate, necessary, corrective action to remedy any noncompliance causing the risk. 
  • Collecting complaint information as provided by users/customers and forward to you as our customer 
  • As an optional service we can provide an annual review of the status of harmonized standards listed on your Declaration of Conformity 


 

*Excluding reasoned requests from authorities. 

Responsibilities of importers


If you import products from outside of the EU, you will take on all the obligations with respect to product compliance within the EU. Therefore, it might be a good choice to appoint an EU Authorized Representative to take care of the above package of services and ensure liability will be reduced 


Cost of Local Representative Services


We would like to give you a fixed up-front price for this service, but as there are many parameters and variables that influence the cost, we request you to send in application through the contact button, so that we can review in order to give you a cost estimate. We should be able to give you an estimate within 3 working days.

Please provide as much information as possible (if available), such as:
-          Manufacturer details (name, address, email, etc.)

-          Product description

-          Applicable EU Directive(s)/Regulation(s)

-          Notified Body number (if applicable)

-          Supposed annual number of items placed on EU market

Information

Certanex India
Flat number 24/c, building 27/b, Mazagon Terrace, S.B. Dhodi Marg,
Mazagon, Mumbai, 40010 India

e: [email protected]