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 mark. Our application process allows manufacturers to build reliability and confidence into their CE marking project.

The scope of our services are published in NANDO under Notified Body (NB) number 2962. Applications for conformity assessment activities to Regulation (EU) 2017/746 on in vitro diagnostic medical devices are accepted in English only.

Four steps before you submit an enquiry: 

1. NANDO

Verify if your device is in QMD scope using NANDO link

2. IVDR CERTIFICATION PROCESS

Get an overview on the steps in our certification process

3. QUOTATION

Get an impression about CE Marking Prices

4. ONLINE CONTACT FORM

Initiate contact via our online contact form

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. 

Downloads

  • TERMS AND CONDITIONS

  • TERMS AND CONDITIONS ADDENDUM

  • PRICE OVERVIEW