Zhermack reaches the finish line of MDR certificate
We are very proud to announce that Zhermack has recently obtained the certificate according to the European Medical Device Regulation (EU) 2017/745 (MDR), which officially came into force from 26th May 2021.
The certificate, issued by the notified body TÜV SÜD, attests that our impression materials – such as alginates, A-silicones and C-silicones – are compliant with the new general safety and operating requirements of the new regulation.
FULFILLING YOUR NEEDS is our motto and our driving principle and one more time we made it real obtaining this crucial milestone: we are at your side in your daily professional life with this important guarantee of safety and efficacy.
Why is this milestone so significant for our company?
Firstly, because Zhermack is among the first companies within the dental sector to be certified under the new MDR regulation.
In addition, this achievement is the result of a huge teamwork started in 2019, which involved several Departments and employees across our company: from Regulatory & Quality people, to Research & Development team, from Clinical Affairs to Marketing and Operations staff.
Because our people are and have always been the key to face and achieve new challenging objectives.
Thanks to the highest levels of quality, efficacy and safety towards the patients ensured by the certificate, we can attest the complete transparency and traceability of our medical devices during their whole life cycle. Zhermack will thus continue to play as leading manufacturer within the dental sector and guarantee the presence of its products in all the strategic markets, with the aim of improving and protecting the public health.