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
CE Product Significant Change Notification and Review  Class 1 Substantial Change Application Class IIa & IIb Non Implantable Substantial Change Application Class IIb Implantable, Class III, AIMD Substantial Change Application IVD Substantial Change Application	MDR 2017/745 Class I:S, M and R  MDR 2017/745 Class IIa, IIb & III Guidance Document - MDR Technical Documentation Checklist Substantial Change Notification - MDR/IVDR MDR Substantial Change Application - I S-M-RSI MDR Substantial Change Application - Class IIa and IIb Non-Implantable MDR Substantial Change Application - Class III and IIb Implantable MDR Application Pack Team-NB Position Paper BPG Technical Doc EU-MDR  2017-745 V1	IVDR Request for Quotation IVDR application form Team-NB IVDR TD best practice guidance IVDR TD application pack Significant change form MDR/IVDR	Vigilance Reporting Quality Management System Substantial Change Application Guidance to NSAI Clients - Common Stage 1 Audit Findings Including Regulatory Guidance to NSAI Clients - Common Stage 1 Audit Findings Non-Regulatory 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