Kettenbach Dental achieves major milestone in quality management

As one of the first dental companies at all to do so, Kettenbach Dental
has successfully achieved certification of its impression materials in accordance
with the new Medical Device Regulation (MDR). In March 2020,
the first audit in compliance with the European Medical Device Regulation
was conducted and passed, and accordingly, Kettenbach Dental has
now been issued with the official certificate by its Notified Body, TÜV
SUD. This is an important quality management milestone for the medium-
sized company, which has made its name around the world with its
products for impression taking and composites.
The new Medical Device Regulation (MDR (EU) 2017/745) of the European
Union replaces the Medical Device Directive (MDD 93/42/EEC) that was previously
valid. It was published on 5/25/2017 with the requirement for binding
implementation by 5/25/2020; this deadline was moved to 5/25/2021 in the
spring of this year.
The implementation of the new MDR represents a fundamental change in the
regulatory requirements and also means considerably more rigorous requirements
for industrial manufacturers in the dental sector in terms of tracking of
products, risk management, clinical evaluations, and technical documentation.
It is becoming increasingly difficult to satisfy the growing demands for quality
management and quality processes in an economically viable scope. The
German Medical Technology Association (Bundesverband der Medizinproduktehersteller,
BVMed) has pointed out in a number of publications that small
and medium-sized companies are disproportionately burdened by the new
documentation and reporting requirements.
It is with great pride that Kettenbach Dental can now claim to demonstrably
satisfy even these significantly more stringent requirements. Its early certification
guarantees that the company can continue to provide its customers with
premium quality products which they can consistently rely on in their practice.