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.
Documents available to download are as follows:
- New Class 1 Application
- Class 1 Substantial Change Application
- New Class IIa & IIb Non Implantable Application
- Class IIa & IIb Non Implantable Substantial Change Application
- New Class IIb Implantable, Class III, AIMD Application
- Class IIb Implantable, Class III, AIMD Substantial Change Application
- All MDD/AIMD 3 Year Renewal Application
- New IVD Application
- IVD Substantial Change Application
- IVD 3 Year Renewal Application
- Vigilance Reporting
- Post Market Surveillance Application
- Equivalence Route
- Quality Management System Substantial Change Application
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
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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