MDD to MDR

This notice serves to inform that the Regulation (EU) 2017/745 of the European Parliament and of the Council, on Medical Devices (MDR) has been enforced as of May 26, 2021, replacing the Council Directive 93/42/EEC concerning medical Devices (MDD). The new regulation imposes stricter regulatory requirements and standards for the manufacture and sale of Medical Devices within the European Union, with the aim of enhance the safety and performance of Medical Devices and ensuring compliance with more stringent regulation and standards.

Our company is actively pursuing formal approval in accordance with the MDR regulation. We are currently in the process of updating our product line to ensure compliance with the latest requirements. We have obtained confirmation of the status of a formal application, a written agreement, and appropriate surveillance within the framework of Regulation EU2023/607, amending Regulation (EU) 2017/745 and (EU) 2017/746 concerning the transitional provision for specific medical devices and in vitro diagnostic Medical Devices. Our dedication to meeting and exceeding the requirements of these regulations underscores our commitment to ensuring the safety, quality, and compliance of our products.