Assured Confidence

CE Marking for Medical Devices

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.

At NSAI, we offer the industry’s only time-to-market process for CE Marking services which includes providing regulatory guidance services to help clients understand the how the directive, including clinical trail requirements are applied to their products. Find out how NSAI can help you get your product certified today.

NOTE: The following links open Word documents that are hosted through our NSAI Inc website

Upload Documentation to NSAI

Instructions: Create a ZIP file containing the following documents

  • Word version of the completed Application or Change Notification form
  • PDF version of the completed Application or Change Notification form (to include signature)
  • All supporting documents required by the relevant Application/Change Notification form

Note: Please send attachments seperately rather than one large pdf file.

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

Interested in CE Marking? You may also be interested in ISO 13485 and CMDCAS.

Contact Details

Europe Offices   USA Office
NSAI European HQ
1 Swift Square
Northwood, Santry
Dublin 9 D09 A0E4
Ireland

T+ 353 1 807 3800
F+ 353 1 807 3878
medical.devices@nsai.ie 
 
NSAI Galway Office
Ballybrit Crescent
Ballybrit Business Park 
Galway H91 NX52
Ireland


T+ 353 1 807 3800
medical.devices@nsai.ie 
NSAI Inc.
20 Trafalgar Square
Suite 603
Nashua, NH 03063
USA


T+ 1 603 882 4412
F+ 1 603 882 1985
info@nsaiinc.com





 
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