MDR – Regulation (EU) 2017/745

CE marking represents confirmation of a medical device manufacturer’s claim that a device meets the General Safety and Performance Requirements (GSPR) of the Medical Device Regulations RE(EU) 2017/745. 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) 2017/745 on medical devices are accepted in English language.

HOW TO APPLY FOR CERTIFICATION

1. NANDO

Verify if your device is in QMD scope using NANDO link

2. YOUR MDR CERTIFICATION PROCESS

Get an overview on the steps in a certification process

3. COST ESTIMATE

Get an impression about CE Marking Prices

4. ONLINE CONTACT FORM

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. 

Downloads

  • TERMS AND CONDITIONS

  • TERMS AND CONDITIONS ADDENDUM

  • PRICE OVERVIEW