Synthesia received MDR certification for its medical devices

We are pleased to announce the receipt of the MDR (Medical Device Regulation) certificate for our complete portfolio of OKCEL haemostats. which have thus demonstrated full compliance with the European Medical Device Regulation 2017/745 (MDR). Compared to the previous Medical Device Directive (MDD), the MDR has a broader scope and stricter requirements, particularly in the areas of clinical evaluation, post-market surveillance, device traceability (UDI, EUDAMED), technical documentation and risk management, and thus aims to ensure the highest level of safety and performance of medical devices. The award of the certificate confirms that OKCEL haemostats meet the highest safety standards and are a high-quality, effective and reliable medical device for both patients and users.