March 27, 2024

Silmet on its way to MDR qualification (2017/745)

In November 2023, Silmet completed Stage 1 and a significant part of Stage 2 of the European Union (EU) Medical Device Regulation (MDR 2017/745) qualification. Silmet's on-site audit resulted in 2 minor non-conformances and 0 major findings.This critical audit phase in the MDR designation process was conducted by MDC, a Notified Body. The successful MDR audit results show our capabilities in all areas of MDR and progression towards achieving the MDR certification soon.The company’s complete Dental Cement line has been developed and is being manufactured in compliance with MDR 2017/745.While changes relating to the new MDR regulations are challenging, this audit result is sending a strong signal to all our customers that they can rely on Silmet’s access to the European market. "We will continue to serve as a reliable partner for dental restorative products," says Moshe Zalsman, CEO of Silmet Ltd. "Silmet set this regulatory transition as a high priority and worked diligently to implement the requirements of the EU MDR. For the last 2 years, we have been working on adapting our production lines and quality management system to meet the MDR's new conformity assessment procedures.The MDR certification is essential to our business, and it took an incredible collective effort to ensure that Silmet is compliant with all the demands. The company's commitment to this transition will help us maintain our product's lead in Europe. With the MDR certification in place, we will continue our mission to provide leading-edge solutions in dental restoration that meet the new standards."