IVDR – Regulation (EU) 2017/746
CE marking is a confirmation of a medical device manufacturer’s claim that a device meets the General Safety and Performance Requirements (GSPRs) of the In Vitro Diagnostics Regulations RE(EU) 2017/746. QMD Services offers conformity assessment to verify such claims and then issue the CE certificate. Our application process allows manufacturers to build reliability and confidence into their CE marking project.
The scope of our services is published in NANDO under Notified Body (NB) number 2962. Applications for conformity assessment activities to Regulation (EU) 2017/746 on medical devices are accepted in English language only.
Four steps before you submit an enquiry:
Please get in contact with us via our Online Contact Form. Following an initial discussion with our Client Team, you will need to submit us relevant information about your company and products.
