ARTICLE SUMMARY:
The Medical Device Regulation takes effect in less than a year and that means some big impending changes for how companies run their post-market surveillance and vigilance programs. Experts from Navigant dig into the implications for industry. By Shweta Agarwal, PhD, Paula Burge, and Chris Holmes, Navigant
To ensure better protection of public health and patient safety, the European Union adapted a series of stricter regulatory frameworks and compliance requirements for medical devices.