MDR Certification: For Verified Quality in Every Detail

As a manufacturer of medical devices, we at SCHEU-Dental bear a special responsibility. 
That is why we meet the requirements of the EU Medical Device Regulation 2017/745 (MDR) 
with the utmost care. Our products stand for the highest quality, safety and performance – confirmed 
by our MDR certification.

What does MDR mean?
The MDR has been mandatory since 26 May 2021 and replaces the former Medical Device Directive (MDD). 
It defines stricter requirements for manufacturers, product classification and post-market surveillance. 
For us, this means: regular scheduled and unscheduled audits by our notified body as well as the preparation 
of comprehensive technical documentation in accordance with the new MDR requirements.  

Which products are certified?
All our MDR-certified medical devices fall under MDN code 1209 (“Non-active non-implantable dental materials”) – 
including, for example, our aligner foils and wires. Devices such as the BIOSTAR® or the MINISTAR S® are not 
classified as medical devices and therefore do not fall under MDR regulations.

Your benefit as a user
For dental laboratories, orthodontists and dental practices, our MDR certification means:

• MDR-compliant medical devices monitored by our notified body
• CE marking with the identification number of our notified body (CE 0044 for TÜV NORD)
• Detailed product documentation
• Made in Germany – tested according to the highest EU standards 

Trust in Certified Quality
Our MDR certification is more than a regulatory requirement – it is an active commitment 
to product safety and quality. That makes the difference when it comes to providing patient 
care at the highest level.

MDR Certification Download
Download (PDF 2.13 MB)