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.

Important Documents

Documents available to download are as follows:

MDD/IVDD	MDR	IVDR	Other Documents
MDD Product Substantial Change Notification MDD Class I Substantial Change Notice MDD Class IIa and IIb Substantial Change Notice MDD Implantable and Class III Substantial Change IVD Substantial Change Application	MDR TD Assessment Submission Pack Guidance Document - MDR Technical Documentation Checklist MDR Substantial Change Notice MDR Class IIa and IIb Substantial Change Submission Pack MDR Class III and Implants Substantial Change Submission Pack	Team-NB IVDR TD best practice guidance IVDR TD application pack IVDR Substantial Change Notice	Vigilance Reporting QMS Substantial Change Notification Guidance on MDR QMS Stage 1 Common Findings Guidance on ISO 13485 QMS Stage 1 Common Findings Guidance to Clinical Evaluation Pathways (MDR 2017-745) Medical Contract Schedule 1 Medical Contract Schedule 2

 

Need Support?

For Product Related Questions or Queries Contact: substantial.change@nsai.ie

For QMS Related Questions of Queries Contact: medicaldevices@nsaiinc.com or medicaldevices@nsai.ie

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