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.
NOTE: The following links open Word documents that are hosted through our NSAI Inc website
- 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
- TYVEK Application Form
- Vigilance Reporting
- Post Market Surveillance Application
- Equivalence Route
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.
NSAI European HQ
1 Swift Square
Dublin 9 D09 A0E4
T+ 353 1 807 3800
F+ 353 1 807 3878
NSAI Galway Office
Ballybrit Business Park
Galway H91 NX52
T+ 353 1 807 3800
20 Trafalgar Square
Nashua, NH 03063
T+ 1 603 882 4412
F+ 1 603 882 1985