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Want to Sell Your Medical Device in Europe? You'll Need a CE Mark.

A CE Mark is your declaration that the product complies with the Essential Requirements of the relevant European Legislation. By having a CE Mark, you will have immediate access to all EU and EEA Markets as well as any other international markets where CE Marking is accepted. Clients will also benefit from improved efficiency resulting from a streamlined quality management systems and gain consistent and effective control of key processes.

Important Documents

Documents available to download are as follows:

MDD/IVDD MDR IVDR Other Documents


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For Product Related Questions or Queries Contact:

For QMS Related Questions of Queries Contact: or

Upload Documentation to NSAI

Instructions: Create a ZIP file containing the following documents:

  • ‘Product Data Folder’ set.
  • Word version of the completed Product Review Form (Folder 0).
  • Signed PDF version of the completed Product Review Form (Folder 0).

Please label the attachments with their content.
In 'subject' field, please put Company name or File number if applicable.
Attach and upload theZIP file using our facility to Upload Documentation to NSAI

Learn More

You may also have in interest in ISO 13485, an internationally recognized standard for a comprehensive management system for the design and manufacture of medical devices. It is often seen as the first step towards achieving compliance with European, Canadian and other regulatory requirements for medical device manufacturers.

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