Increasing Role for Device Patient Safety in Device and Combination Products
The Medical Device Regulation (MDR 2017/745) compliance takes effect in less than one year, meaning big impending changes for how medtech companies run their post-market surveillance and vigilance programs. What are the industry implications? In practical terms this means:
Many legacy products will need to be recertified
Many devices will be reclassified as higher risk
And devices in development will be held to a more rigorous approval process
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