The FDA’s guidance on Predetermined Change Control Plans (PCCP) offers clear recommendations for integrating AI-enabled device software functions into the medical device industry. This framework allows manufacturers to implement pre-approved modifications to their AI-driven software without requiring new marketing submissions, streamlining the regulatory process. By addressing the unique needs of AI algorithms, such as ongoing updates and improvements, the PCCP ensures that these advancements maintain safety, efficacy, and compliance. The FDA emphasizes transparency and monitoring, enabling medical devices to evolve while adhering to rigorous regulatory standards. This innovative approach fosters AI innovation, empowering companies to deploy responsive and adaptive AI-enabled medical technologies that enhance patient care and outcomes.

The MDCG 2024-15 guidance provides crucial instructions on managing clinical investigation reports and plain-language summaries in the absence of EUDAMED, the European database for medical devices. This interim solution ensures compliance with MDR Article 77, emphasizing the importance of transparency and public accountability. Sponsors must submit clinical reports within one year of the investigation's conclusion or three months for early terminations, with public access aligning with device registration or defaulting to one year after submission. To address the gap left by EUDAMED, national procedures and the CIRCABC directory will temporarily facilitate the sharing of these documents. By adapting to these measures, stakeholders can maintain regulatory compliance and foster confidence in the medical device industry, aligning with evolving EU regulations.