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Why Must? Who Should? When should I start? How to proceed? Frequently Asked Questions (FAQs) Cost & Fees
Cost and Fees Let Wellkang be your EU/EC European Authorized Representative! Click here to learn more/continue ...

Register your Medical Devices (MDs & IVDs) in Europe with Competent Authority MHRA- UK Medicines and Healthcare products Regulatory Agency.

As of 21 March 2010, a Single EU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA & other EU/EFTA authorities by world-leading CE Marking
Specialists based in London/UK. Click here to get FREE Guide Now!

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.


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