Medical Device CE Marking Management System Registration and Certification Services

CE mark is a legal requirement to place a medical device on the market anywhere within the European Union.  In conjunction with ISO 13485 certification, this device specific evaluation supports a manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives that details the safety and performance requirements for medical devices.  As a designated Notified Body under the Medical Device Directives, NSAI has the technical expertise and experience to provide the applicable CE marking services.

See also the MDR/IVDR Information.

MDR Documents

MDR 2017/745 Class I: S, M and RS

MDR 2017/745 Class IIa and IIb Non-Implantable 

MDR 2017/745 Class III and IIb Implantable

MDD/IVD 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

New IVD Application

IVD Substantial Change Application

IVD 3 Year Renewal Application

Vigilance Reporting

Post Market Surveillance Application

Equivalence Route

Request For Quote

Apply For Registration

Substantial Change QMS

Medical Contract Schedule 1

Medical Contract Schedule 2

Standards Purchase

Customer Feedback

NSAI.ie Website

IDA Irish Development Agency