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 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!

Would you welcome an opportunity for the same marketing ease in Europe as you enjoy in your home market?

Would you prefer investing your time and effort in sales rather than trying to understand the complex European product regulations and certification procedures?

Then you will appreciate the service Wellkang 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 Wellkang experts.

It is required by the EEA legislation that a non-EEA manufacturer must print its EEA/EU Authorised Representative´s name, address & contacting details on the packaging/labeling of the product(s) sold onto the EEA (EU & EFTA) market. The authorities from any of the 28+3 EEA (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.

* You can find a list of the 31 EEA (EU & EFTA) countries at our webpage http://www.wellkang.com/abouteu.html.



Why must the manufactures of medical devices designate a EU Authorized Representative?

The European Union's 'New Approach Directives' are mandatory on all member countries to enact through national legislation. This legislation requires manufacturers to display Marking on their products, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) "an offense to place a product on the market without Marking". The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying Marking.

For medical devices, it is compulsory, under the Medical Devices Directive which became effective on 14/Jun/1998, that the manufacturer designate an Authorized Representative which has to be located in European Union member states to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so by the Surveillance Authorities.


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!