OHST is MDR-ready!
We have used the time until today intensively to adapt our processes and products to the requirements of the Medical Device Regulation (EU) 2017/745 (MDR) in due time. In recent months, the Product Management, Regulatory Affairs and Quality Management departments in particular, have worked on making the technical documentation for our products and our processes MDR-compliant.
We are more than pleased to announce that we were successfully audited by our notified body according to
MDR criteria at the end of February 2021. The scope of the audit covered surgical instruments including sample components and custom-made products in endoprosthetics. We can expect the corresponding certificate shortly.
The approval for the OHST implant systems, in accordance with Regulation (EU) 2017/745 on medical devices (MDR) is planned to take place step by step until the beginning of 2024. We will inform you in due time about necessary product portfolio adjustments and new product systems.
As a German family-owned company with over 80 years of experience in the development and manufacture of precision implants and instruments, we think and act with a long-term orientation. A trusting cooperation at eye level with our partners is essential for our joint success. We will continue to supply safe medical products for the benefit of the patients.