Geistlich has announced the receival of Medical Device Regulation (MDR) certification from TÜV SÜD Product Service GmbH for its established collagen portfolio product lines of Geistlich Bio-Gide, Geistlich Fibro-Gide and Geistlich Mucograft, fulfilling the new EU regulations.
According to Geistlich, all indications for these products, which include a variety of regenerative procedures have been confirmed, despite the increased and more demanding quality and evidence requirements of the MDR.
This marks Geistlich as one of the first companies in the field of regenerative dentistry to receive MDR certification for its collagen product range. The company added that doctors can therefore rely on a complete range of collagen products that meet their high standards of quality and therapeutic safety.
“With the MDR certification, long before the official transition period ends, we underline our commitment to the highest quality standards and patient safety, which we share together with doctors,” said Diego Gabathuler, CEO of Geistlich.
Geistlich Fibro-Gide is the first non-active class III medical device of animal origin to be certified according to MDR by TÜV SÜD Product Service GmbH. With its four subsidiaries and numerous sales partners in Europe, Geistlich has been committed to the well-being of patients on the continent for decades and is driving medical regeneration forward.
Related: Geistlich Mucograft approved for used in extraoral areas
