An Authorized (Authorised) Representative is the one who will represent the manufacturer to deal with the CE Marking vigilance authorities from the 27 EU + 3 EFTA * Member States. This is somehow similar to that you may need a lawyer representing you in the court.

The Authorised Representative usually does NOT involve itself in the distribution and/or sales of the products as the importers/distributors usually do.

Most of the importers/distributors are skilled in marketing and sales, but not familiar with the complicated CE Marking issues.

A non-EU manufacturer needs only one Authorized Representative in the entire European Union whereas may have many distributors and/or sales agents.

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/labeling of the product(s) sold onto the EU & EFTA market. The authorities from any of the 27+3 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.

FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices

• Is my product a Medical Device?
  
• How to classify Medical Devices?
• Medical device CE Marking procedures
  
• Steps to obtain CE Marking for your Medical Devices
  
• Legal basis for medical devices
  
• Why must a medical device manufacture appoint a European Authorized Representative?
  
• Why must inform/notify/register with the Competent Authority such as MHRA?
  
• Who should apply/register with the Competent Authority such as MHRA?
  
• When to inform/notify/register with the Competent Authority such as MHRA?
  
• How to inform/notify/register with the Competent Authority such as MHRA?
  
• Cost and fees for the registration of medical devices with MHRA
• Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA
  for In Vitro Diagnostic Medical Device (IVD)
• Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA
  for Medical Device (MD)
• Role of the European Authorised Representative (Authorized Representative) in the MHRA registration
  
• How to change the registered details with MHRA?
  
• FAQs: Frequently Asked Questions about registration with Competent Authorities in Europe
  
• Register/Notify your Medical Device (MD) & In Vitro Diagnostic Medical Device (IVD) with MHRA-
  UK Medicines and Healthcare products Regulatory Agency now!
• Conformity Modules applicable for CE marking of MD and IVD Medical Devices
  
• All Certificates Notified Bodies can issue under the 3 medical devices directives
  
• Class I (including Is & Im) medical devices CE Marking procedures
  
• Class IIa medical devices CE Marking procedures
  
• Class IIb medical devices CE Marking procedures
  
• Class III medical devices CE Marking procedures
  
• IVD-In Vitro Diagnostic medical devices CE Marking procedures
  
• AIMD-Active Implantable medical devices CE Marking procedures
  
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• What is CE marking?
  
• The CE marking logo
  
• What is a manufacturer?
  
• Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
  
• Why is CE marking called "European passport"?
  
• Does my product need CE Marking for the European Market?
  
• How to obtain CE Marking for my product?
  
• Where can I find CE marking related publications & guidelines?
  
• How to distinguish EU directives?
  
• Where can I find CE marking testing labs nearest to my location
  
  
• For more information, please visit our Questions and Answers section.
  Please click here to contact us. Our Wellkang team at a world leading regulatory consultancy are ready to help you!