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.