Medical Device
All medical devices, regardless of their classification, require a clinical evaluation study to demonstrate the safety and performance by providing clinical evidence. Moreover, two recent regulations - Medical Device Regulation (MDR), to take effect on May 26, 2020, and In Vitro Diagnostics Regulation (IVDR) to take effect on May 26, 2022 - will create stricter requirements for clinical evidence and increased oversight by regulatory agencies.
These regulations will not allow previously approved products, so device manufacturers will have to re-evaluate their entire product portfolio to identify the necessary steps to ensure compliance. Medical device manufacturers will likely need additional clinical data to certify and re-certify devices as well as perform other post-market monitoring studies to provide safety and effectiveness for the lifecycle of a device.
As the fifteenth largest economy in the world and with a population of 80 million, Turkey presents an exciting opportunity for investment and development in the area of the Medtech industry and healthcare. Recently, a draft Medical Device Regulation ("Draft Regulation") has been prepared and announced by the Turkish Ministry of Health, with the intention and purpose of harmonizing and aligning the Turkish regulatory framework for medical devices with the new EU regulations.
MonitorCRO team knows and understands medical device and diagnostics regulations. Despite the everchanging regulations and increasing difficulty in obtaining approval for clinical investigations, we offer a full range of integrated services customized to meet the needs of each client. MonitorCRO has successfully assisted clients from regulatory applications to performing studies and product approvals. Whether it is medical device clinical research or regulatory submission, you are in safe, expert hands.