Milestone as Kilkenny firm secures certification for wound care product

Kilkenny-based medical device manufacturer CF Pharma Medical has achieved Class IIb certification under the European Medical Device Regulation (MDR) for its Effigerm Wound Care product, marking a significant milestone for the company.

The certification follows a substantial programme of technical development, clinical evaluation and regulatory assessment to meet the enhanced requirements of the MDR framework. The achievement supports the company's continued growth in international healthcare markets.

Effigerm Wound Care is designed for wound cleansing, debridement and irrigation, helping to create and maintain an optimal wound healing environment. The product is intended for use across a broad range of wound care applications and is available in both liquid and hydrogel formulations.

The newly approved MDR certification provides an enhanced regulatory platform for future market expansion and strengthens opportunities for collaboration with healthcare partners and distributors across Europe and beyond.

"This is a proud achievement for our team and an important milestone for CF Pharma Medical,” said Caroline Fogarty, Managing Director of CF Pharma Medical.

“Achieving MDR Class IIb certification requires a significant investment in quality systems, technical documentation, clinical evaluation and regulatory compliance. The certification reflects the hard work and expertise of our entire team and provides a strong foundation for future growth from our Kilkenny base."

The certification comes as CF Pharma Medical continues to invest in its operations in Kilkenny, supporting innovation, manufacturing excellence and the development of products for international healthcare markets.

With MDR certification now secured, the company is well positioned to expand existing partnerships, develop new commercial opportunities and continue delivering innovative wound care solutions to healthcare professionals and patients worldwide.