Bravida Medical Achieves MDR Certification, Expanding Access to European Markets

Silverlon Burn Wrap Dressings

Securing MDR certification is a major milestone for our organization and a huge step forward in making our solutions available to more patients across Europe.”

— Raul Brizuela, CEO of Bravida Medical

GENEVA, IL, UNITED STATES, March 11, 2025 /EINPresswire.com/ -- Bravida Medical, a leader in advanced wound care, urinary management and securement solutions, has successfully obtained European Medical Device Regulation (MDR)

certification under Argentum Medical, a Bravida Medical company, making it one of the first Class III medical device companies in the United States to achieve this milestone. This certification marks the culmination of five years of dedicated work to meet the European Union’s most rigorous medical device standards, paving the way for Bravida Medical to expand its presence in European markets.

The Medical Device Regulation (EU) 2017/745 replaces the previous Medical Device Directive (MDD), introducing stricter requirements for clinical evidence, post-market surveillance, and manufacturer accountability. MDR raises the bar for patient safety and product performance, requiring companies to meet more stringent standards before bringing Class III medical devices to market in Europe.

“For the past five years, our team has worked tirelessly to navigate the evolving regulatory landscape in Europe,” states Raul Brizuela, CEO of Bravida Medical. “Securing MDR certification is a major milestone for our organization and a huge step forward in making our solutions available to more patients across Europe."

With MDR certification, Bravida Medical is now positioned to introduce its advanced wound care, urinary management and securement portfolio – including Silverlon®, Men’s Liberty™, and CathGrip® – to European healthcare providers. These products are designed to improve patient outcomes, enhance infection control, and provide superior securement solutions for hospitals and healthcare facilities.

Bravely Advancing Healthcare
Bravida Medical has made significant investments in research, clinical validation, and regulatory compliance to ensure its products meet the highest global standards. Earning MDR certification is a significant achievement, allowing Bravida Medical to expand into new markets and serve more patients and healthcare providers in Europe.

For more information about Bravida Medical’s MDR-certified products, please visit www.BravidaMedical.com.

About Bravida Medical
Bravida Medical is a leader in advanced wound care and securement, pioneering the use of silver-plated nylon technology to create innovative antimicrobial solutions. Its flagship product, Silverlon® dressings, is trusted by healthcare professionals worldwide for surgical, vascular and chronic wounds, burns, and infection prevention. In addition to Silverlon®, Bravida Medical offers a range of securement and urinary management solutions, including CathGrip®, Men’s Liberty™, and Men’s Liberty Acute™. As one of the first U.S.-based Class III medical device companies to achieve MDR certification, Bravida Medical continues to expand its global reach while staying committed to improving patient outcomes.