CONFORMITY ASSESSMENT

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 or the Medical Device Regulation RE(EU) 2017/745.
QMD Services offers conformity assessment to verify such claims and then issue the CE certificate.

The scope of our services is published in NANDO under Notified Body (NB) number 2962. Applications for conformity assessment activities are accepted in English language only.

Four steps before you submit an enquiry:

1. NANDO

Verify if your device is in QMD scope using NANDO link

2. CERTIFICATION PROCESS

Get an overview on the steps in our certification process

3. COSTS & SERVICES

Get an impression about CE Marking Prices

4. ONLINE APPLICATION FORM

Initiate contact via our online form

Please get in contact with us via our online application form. Following an initial discussion with our Client Team, you will need to submit to us relevant information about your company and products. After having received the information via our online application form, we will arrange an initial meeting with you to discuss all further steps towards your formal application.