As one of the first companies in its field, the regeneration specialist Geistlich has successfully completed the approval process for its entire product portfolio in accordance with the new Medical Device Regulation (MDR) of the European Union (EU) 2017/745. Geistlich thus meets the highest European standards of quality, safety and performance for medical devices.
Strong scientific evidence
For MDR certification, clinical and preclinical evidence as well as safety and performance data were thoroughly reviewed. Since the project to achieve certification started in 2017, Geistlich has submitted more than 2,200 documents with almost 40,000 pages and had its quality management system audited according to MDR. The entire process required several years of collaboration between teams from different departments and shows how challenging it is to obtain MDR approval even for established products. "Without the solid scientific basis of our products and our high quality standards, MDR certification would not have been possible so quickly," says Diego Gabathuler, CEO of Geistlich.
Safe and effective solutions
The early MDR certification of all Geistlich products, even before the official deadline in 2027, underlines the company's strong commitment to the highest quality and safety standards. The certification is both proof and an incentive to continue to provide safe and effective solutions for patients and healthcare professionals, and to continue to advance the field of medical regeneration.