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.

If your company is looking for a quick turn around on a CE Mark for your medical device, NSAI has the answer. In addition to our normal delivery options, we offer our FastTrack service for all classes of medical devices which means your company can obtain your CE Marking in as little as 45 days.

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 cut through the regulatory red tape and get your product certified today.
 

Upload Documentation to NSAI

• 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

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