Oxylitre is currently progressing through its EU MDR submission, demonstrating our continued commitment to quality, safety and reliable medical device manufacturing.
The EU Medical Device Regulation represents a significant step forward in medical device oversight, placing greater emphasis on product safety, technical documentation, clinical evaluation, post-market surveillance and ongoing compliance.
For Oxylitre, working towards EU MDR is more than a regulatory requirement. It is a reflection of our commitment to producing dependable medical equipment that healthcare professionals can trust.
Experience adapting to change
Oxylitre has seen medical device regulation evolve many times throughout its history. In 1998 we adopted the requirements of the Medical Device Directive (MDD) as part of our ongoing commitment to meeting recognised medical device standards.
Today, as we work towards EU MDR, we continue that same approach: respecting the experience and knowledge built over decades, while adapting to new requirements and expectations within the medical device industry. This combination of long-standing experience and willingness to evolve is central to who we are.