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. We gladly accept submissions of technical documentation in English and German.
For German submissions, acceptance is subject to the availability of reviewers with the appropriate language skills.
Get in touch with us as soon as possible!
Please get in contact with us via our online application form. We will get back to you immediately to discuss the next steps.
“Structured Dialogue” is an integral part of our process – starting from day one.
Following this initial meeting 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. Find more details about the process in our “Cost and Services Overview“.