Cost and fees

The cost and fees involved in the CE marking of Medical Devices will normally include the follows:


1. Certification Fees charged by Notified Bodies
   Notified Bodies always charge fees for issuing EC Certifications, the fees charged by the Notified Bodies, which are in general profit-driven organizations in the private sector, varies from Notified Body to Notified Body, from country to country.
   
   
2. Official Fees charged by governmental Competent Authorities
   The EEA Competent Authorities, which are in general non-profit governmental agencies in the public sector, normally charge fees for the processing and administration of the registration/notification of manufacturers and devices of MDs/IVDs. The procedures and official fees vary greatly from Member State to Member State among the 30 EEA countries. For instance,
   
   
   • in UK,
     the Competent Authority MHRA charges a statutory fee of 70GBP (about US$120) each time for registration, notification, update or change of the registration details held with the MHRA.
   • in Spain,
     the Competent Authority charges a fee starting at 455.12Euro (about US$705) per product for registration/notification;
   • in Sweden,
     the Competent Authority charges annually a Registration Fee of 2150SEK (about US$320) per manufacturer, plus a Registration Fee, based on number of products, starting at 1000SEK (about US$150) for 1 to 10 products.
     
     
   Click here NOW ! to learn more about the registration/notification procedures and official fees charged by the Competent Authorities in 30 EEA member states.
   
   
3. Authorised Representative Fees
   Non-EEA manufacturers MUST appoint an Authorised Representative who has a registered business in EEA countries. The Auth Rep fees may vary depending on the level of services, knowledge & reputation of the firm, taxation of the country domiciled, etc. As a world-leading consultancy in CE marking, Wellkang is proudly present you with high-standard of services at competitive prices. Click here to view our Auth Rep fee list.
   

• 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)
• FAQs: Frequently Asked Questions
  
• Role of the European Authorised Representative (Authorized Representative) in the MHRA registration
  
• How to change the registered details with MHRA?
  
• Is my product a Medical Device (MD) or In Vitro Diagnostic Medical Device (IVD)?
  
• How to classify Medical Devices (MD)?
• Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?
• Why must a medical device manufacture appoint a European Authorized Representative?
  
• Click here to contact us for a quotation

• Is my product a Medical Device (MD) or In Vitro Diagnostic Medical Device (IVD)?
  
• How to classify Medical Devices (MD)?
• Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?
• Why must a medical device manufacture appoint a European Authorized Representative?
  
• Why must inform/notify/register with the Competent Authority?
  
• When to inform/notify/register with the Competent Authority?
  
• Who should apply/register with the Competent Authority?
  
• Changes to registered details?
  
• Cost and fees for the CE Marking of medical devices
• CE Marking Conformity Assessment Procedures according to different Modules
  
• 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
  
• Medical device CE Marking procedures
  
• Steps to obtain CE Marking for your medical devices
  
• Legal basis for medical devices
  
• 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
  
• Required content for the CE marking EC Declaration of Conformity
  
• 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
  
  
• Why choose Wellkang?
• How can Wellkang help you?
• What are included in Wellkangs EU Authorized Representative Service?
• 11 benefits by appointing Wellkang as your EU Authorized Representative?
• 3 unique benefits offered by Wellkang that are not available from others?
• Why do you need a representative in Europe?
• Why is the Authorized Representative different from the importer/distributor ?
• Classification: how to classify Medical Devices?
  
  
• 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!