Are you ready for Brexit impacts? Do you have a Brexit contingency plan? You may need either an EU/EC European authorized representative based in EU-27 countries or a UK Authorised Representative (so-called "UK Responsible Person") based in UK, or may need both EU & UK representatives, depending on different brexit scenarios. Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland). Wellkang team can help you under all Brexit scenarios! Click here to get FREE Guide Now!

An Authorized (Authorised) Representative is the one who will represent the manufacturer to deal with the CE Marking vigilance authorities from the EEA (28 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-EEA 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 EEA legislation that a non-EEA manufacturer must print its EEA Authorised Representative´s name, address & contacting details on the packaging/labeling of the product(s) sold onto the single EEA (28 EU + 3 EFTA) market. The authorities from any of the EEA (28 EU + 3 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.

The European Economic Area (EEA):

The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market.

Switzerland is neither an EU nor EEA member but is part of the single market.



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

• Are you ready for Brexit? Wellkang can help under all Brexit scenarios!
  
• 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
  
• Click here to contact us for a quotation

• 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!