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:
- 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.
- 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,
Click here NOW ! to learn more about the registration/notification procedures and official fees charged by the Competent Authorities in 30 EEA member states.
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.
- 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.
FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices
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