Medical device CE Marking procedures

Posted on February 1, 2012. Filed under: Uncategorized |

Depending on the individual case, each Medical Device manufacturer must choose its own and most suitable conformity module(s) which address(es) its particular product categories and business needs.

It is very important to select your European Authorized Representative like Wellkang before you choose a Notified Body from more than 100 of them based in 30+ countries; As your Auth Rep, Wellkang will particularly assist you in classifying your product before submission to the most suitable Notified Body.

Steps to obtain CE Marking for your Medical Devices

  1. Appoint Wellkang as your single European Authorized Representative within the 30 EU+EFTA countries.
  2. Wellkang assist you in identifying all EU Directives applicable to your product.
  3. Wellkang assist you in classifying your device.
  4. Wellkang assist you in selecting the most appropriate conformity assessment module.
  5. Wellkang assist you in selecting your Notified Body, if your chosen conformity module requires so, to perform the third-party conformity assessment tasks.
  6. Wellkang assist you in assessing your device according to Essential Requirements.
  7. Wellkang assist you in preparing the “Technical File”.
  8. Wellkang assist you in preparing your “Declaration of Conformity”.
  9. You affix the CE Marking on your device and start to sell.
  10. Wellkang EU Authorized Representative Service AFTER you have affixed CE Marking on medical device

    Wellkang continue acting as your Auth Rep for vigilance and inspection purpose while your CE-Marked devices are placed on the European market by you directly or through your local European distributors. Our service mainly covers the follows:

    • 10.1 Publish Your Device:
      At webpage for third party verification
    • 10.2 Product Registration:
      If applicable, we can register your product in EU and get your product a Certificate of Registration.
    • 10.3 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.
    • 10.4 Keep Your Technical Files:
      We store and update the Technical Files of your products sold in Europe. The Technical Files may be inspected at any time by the Competent Authorities for a period ending at least five (5) years after the last product has been manufactured.
    • 10.5 Legislation Monitoring:
      We monitor and report on new developments in European product legislation relevant to your products.
    • 10.6 Vigilance and Incident Reporting:
      We assist with product vigilance and incident reporting.
    • 10.7 Product Recalls and Advisory Notices:
      We assist with Product Recalls and the issuing of Advisory Notices

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