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!

• 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 (CE mark)?
  
• The CE marking logo (Free download CE mark logo)
  
• Download of the EC Rep symbol/logo
  
• CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content
  
• What is a manufacturer? What are the responsibilities of 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
  

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 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.

* You can find a list of the 30 EU & EFTA countries at our webpage http://www.wellkang.com/abouteu.html.



Why must the manufactures of medical devices designate an EU/EC 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.

Why is the Authorized Representative different from the importer/distributor ?

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.

Why choose Wellkang?

Wellkang Group of Companies- a world leading regulatory consulting group in: CE Marking WEEE registration and RoHS compliance and solutions; US FDA affairs incl. 510(k) PMN submission, UL mark; and China's CCC Mark & China RoHS compliance and solutions. Wellkang help worldwide exporters to gain global market access. Wellkang have offices in the USA (Melbourne/FL, Wilmington/DE), Europe (London, Stockholm) and Asia (Hong Kong, Shenzhen, and Xi'an). As a world-leading business-to-business consulting firm, Wellkang group is proud of that we have served clients/customers from more than 100 countries among which there are Fortune 500, multinational companies as well as governmental authorities and international organizations. One of our main website, www.CE-marking.org, has received more than 15,000,000 (Fifteen Millions) visitors and been constantly ranked on top for search term CE marking by major search engines such as: Google, AltaVista, Yahoo and DMOZ. Wellkang has been placed and highly ranked among world's top Import/Export Consulting Firms selected by the world's most prestigious web directories such as Google Web Directory, Open Directory, and top search engines and hundreds of other directories.

Wellkang has been recommended as service provider to local exporters by varies governmental export promotional agencies from different part of the world



How can Wellkang help you?

Wellkang's mission is to 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. Wellkang strives to establish a close, trusting relationship with our clients based on proven performance and total dedication to their products.

1. EU Documentation and Standards Delivery Service.

   • 1.1 EU Product Directives
   • 1.2 European Standards
   • 1.3 Other EU Official Documents

2. Technical Consulting Service

   • 2.1 Technical Advice on Compliance Engineering
   • 2.2 Safety and Risk Assessments

3. Compliance Testing Service

   • 3.1 Pre-compliance testing arrangement
   • 3.2 Full-compliance testing arrangement

4. Technical Documentation Service

   • 4.1 Technical Files (Technical Documentation):
     guiding you preparing this document.
   • 4.2 EC Declaration of Conformity:
     guiding you preparing this document, we have different models in several languages.

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

   • 5.1 Users Manual and Installation Instructions
   • 5.2 Labeling Advice and Translation

6. EU/EC Authorised/Authorized Representative (EC Rep) Service

   • 6.1 Product Registration:
     We can register your product in EU for the first time and get your product a Certificate of Registration.
   • 6.2 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.
   • 6.3 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.
   • 6.4 Legislation Monitoring:
     We monitor and report on new developments in European product legislation relevant to your products.
   • 6.5 Vigilance and Incident Reporting:
     We assist with product vigilance and incident reporting.
   • 6.6 Product Recalls and Advisory Notices:
     We assist with Product Recalls and the issuing of Advisory Notices

1. Wellkang offers you a foothold in Europe: a name, an address, a telephone and fax number. Save you the cost of opening an office in Europe.
   
   
2. Make the EU market entrance simple: You need only ONE European Authorized Representative like Wellkang in the entire 27+3 European countries to deal exclusively with the CE marking regulatory issues, whereas you may have as many as you want importers, distributors and sales representatives in Europe.
   
   
3. Gain new EU market: as long as your products are affixed with CE Marking, importers, distributors and sales representatives will be easier to come by as they do not have to deal with complex conformity issues and product certification which require professional in-depth expertise. Your distributor may excel in marketing and sales, but is he equipped or even interested in handling regulatory and legal issues?
   
   
4. Wellkang acts as the contact person for market surveillance authorities and end users when conformity issues are concerned.
   
   
5. Wellkang stores and updates the technical files of the products sold in Europe, and makes them available to the appropriate authorities upon request.
   
   
6. Wellkang registers your products (Class I Medical Devices) with the appropriate authorities. Wellkang provides advice on the implementation of European technical regulations and guides clients through the certification procedures.
   
   
7. Wellkang monitors and reports on new developments in European product legislation relevant to clients.
   
   
8. Wellkang offers product vigilance and incident reporting.
   
   
9. Wellkang assists with product recalls and the issuing of advisory notices.
   
   
10. Wellkang's annual fee is fixed and includes all services; no additional hourly rates are charged, no hidden fees.
    
    
11. Keep your business secrets confidential: it is Wellkang that keeps your technical files, not the European distributor(s) who might turn(s) into one of your future competitors.
    

1. As a world-leading business-to-business consulting firm specialized in CE Marking, Wellkang is proud of that we have served clients/customers from more than 100 countries among which there are Fortune 500, multinational companies as well as governmental authorities and international organizations. One of our main website, www.CE-marking.org, has received more than 15,000,000 (15 Millions) visitors and been constantly ranked on top for search term CE marking by major search engines such as: Google, AltaVista, Yahoo and DMOZ. Wellkang has been placed and highly ranked among world's top Import/Export Consulting Firms selected by the world's most prestigious web directories such as Google Web Directory, Open Directory, and top search engines and hundreds of other directories.
   
2. Our Marketing Department will design an One-page website (we call it Identity Page) with brief introduction of your products together with the copy of your Certificate of Registration, if applicable. This page will be in several major European languages in order to show your products' accreditation to both the CE Marking Vigilance/Surveillance Authorities and your importers, distributors and customers. This page will be published at website www.CEmark.info and the URL will be:
   http://www.CEmark.info/lvd/YourProduct.html, or
   http://www.CEmark.info/mdd/YourProduct.html, or
   http://www.CEmark.info/machinery/YourProduct.html, or
   http://www.CEmark.info/ppe/YourProduct.html, or
   http://www.CEmark.info/toy/YourProduct.html, etc.
3. We will regularly submit your Identity Page to about 1500 search engines. Therefore, your potential buyers will have more chances to find your products.

• What is CE marking?
  
• The CE marking logo
  
• What is a manufacturer?
  
• Why is CE marking called "European passport"?