Geistlich receives EU certification for collagen portfolio
Wolhusen/Schlieren - Geistlich Pharma has received MDR certification for its collagen product range and thus meets the new EU requirements. The products will be used in a variety of regenerative dental procedures.
Geistlich Pharma from Wolhusen in the canton of Lucerne, which is part of Geistlich Group based in Schlieren in the canton of Zurich, is the first company in the field of regenerative dentistry to receive MDR certification for its collagen product range. This confirms that the new EU requirements of the Medical Device Regulation (MDR) have been met and, according to the press release, it relates to the product lines Geistlich Bio-Gide, Geistlich Fibro-Gide, and Geistlich Mucograft.
Despite the MDR’s increased, more demanding requirements regarding quality and evidence, all indications for these products have been confirmed, including a variety of regenerative procedures, according to the press release. Diego Gabathuler, CEO of Geistlich Pharma, commented: «With the MDR certification, we are underlining our obligation to the highest quality standards and patient safety together with physicians.»
According to the press release, Geistlich Fibro-Gide is the first class III nonactive medical device of animal origin to receive MDR certification from TÜV SÜD Product Service GmbH. The company states that the MDR certification is «particularly pleasing» for Geistlich Mucograft, which is now also approved for indications on the face besides the mouth.
Geistlich adds that unlike autologous skin transplants, which use the patient’s own skin, Geistlich Mucograft does not require tissue removal. The short surgery time, simple aftercare, and rapid healing have led to good acceptance of Mucograft by patients.
