Since May 2021, medical devices manufacturers operating and/or selling within the EU must comply with the EU MDR (EU 2017/745). The regulation’s objective is to improve patient safety by evaluating existing devices (e.g. through PMS and PMCF) and ensuring transparency throughout a device’s lifecycle.
In a recent survey conducted by KPMG and RAPS, 66% of respondents said they hadn‘t started planning for the long-term ramifications of MDR compliance, and only 27% believed they would be fully compliant by the cut-off in May 2020.
Despite the amount of bureaucracy, increased costs, and longer waiting times the new regulation may entail, it has the potential to fundamentally change the MedTech industry. In this Playbook, we gaze into the future and predict five key ways in which we believe the MDR will shape the MedTech world and how companies can use it as a leverage for growth, such as:
We hope you will enjoy reading this Playbook! If you have any issues accessing it or any additional questions, please feel free to reach out to us at any time: