Mar
13,
2025
Mar 13, 2025
Lallemand is proud to announce that we have successfully obtained the Medical Device Regulation (MDR) certification, marking a significant milestone in our pursuit of excellence within the medical device industry.
The MDR certification underscores our commitment to maintaining rigorous standards. With the CE mark under MDR, our range of pump spray products meets the highest safety and performance criteria.
Thanks to our robust clinical documentation and technical file the advantages of this certification will translate into a consistent up-grade our claim, specifically in:
INDICATION: for the treatment of symptoms of acute infectious rhinitis, such as cold and flu, for both children and adults.
CLINICAL BENEFIT: we have obtained the written claim of clinical benefits, including the reduction in severity and duration of acute infectious rhinitis, as well as the shortening of standard treatment durations for infectious rhinitis and a general reduction of the impact of infectious rhinitis on quality of life.
This certification also validates our robust Quality Management System (QMS), reflecting our dedication to superior quality across all operations.
The MDR represents one of the most significant regulatory changes in the European medical device industry, enhancing patient safety, improving product quality, and ensuring that all medical devices on the European market meet stringent standards.
We extend our heartfelt gratitude to the entire team involved in this achievement. Together, we will continue to innovate and lead in the medical device industry, ensuring the highest standards of quality and safety for our products.
For more information and availability about our products, please reach out to us.
