Geistlich has received MDR (Medical Device Regulation) certification from TÜV SÜD Product Service GmbH for its established product lines of Geistlich Bio-Gide®, Geistlich Fibro-Gide® and Geistlich Mucograft®, fulfilling the new EU regulations. Despite the increased and more demanding quality and evidence requirements of the MDR, all indications for these products, which include a variety of regenerative procedures, have been confirmed. Doctors can therefore rely on a complete range of collagen products that meet their high standards of quality and therapeutic safety.
Pioneer in medical regeneration, extended range of indications
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. The MDR certification for Geistlich Mucograft®, which is now also approved for indications outside the mouth in the facial area, is particularly pleasing.
Commitment to the highest quality standards and patient safety
Diego Gabathuler, CEO, says: “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.” 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.