ARTICLE SUMMARY:
With MDCG guidance on change control promised by year’s end, notified bodies and experts weigh in on how much latitude device and digital health firms should have in making product modifications, and where PCCPs fit in. Europe could offer more room than the US for continuous innovation—if it can settle on which changes need notified body approval.
Change is the engine of medtech innovation. The constant refining of medical devices and their use cases is central to how the sector operates, and the iterative cycle has never been more rapid than with the rise of software and AI in medtech.
This dynamic raises challenges for a highly regulated industry, where gatekeepers need to balance the dual goals of ensuring the most up-to-date marketed version of a product is properly vetted while not clogging the cycle of development and innovation unnecessarily.
