IVDR – Regulation (EU) 2017/746
CE marking represents 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 activities necessary to comply with this regulation. Our review processes allows you to build reliability and confidence into your CE marking project.
QMD Services offers conformity assessment activities as published in NANDO under Notified Body (NB) number 2962. Applications for conformity assessment activites acc. to Regulation (EU) 2017/746 on in vitro diagnostic medical devices are accepted in German or English language.
HOW TO APPLY FOR CERTIFICATION
Verify if your device is in QMD scope using NANDO link
Get an overview on the steps in a certification process
Get an impression about CE Marking Prices
Initial contact via online contact form
Please get in contact with us via our Online Contact Form. Following an initial discussion with our Customer Service Team, you will need to submit us relevant information about your company and products.
TERMS AND CONDITIONS
TERMS AND CONDITIONS ADDENDUM
Good To Know
QMD Services GmbH
1010 Vienna, Austria
Tel.: +43 1 533 0077
Am Winterhafen 1
4020 Linz, Austria
+43 1 5330077
IVDR designation achieved!