IMDRF Presents Playbook for Evaluating Medical Devices Based on Artificial Intelligence
The International Medical Device Regulators Forum (IMDRF) has published a Playbook dedicated to the evaluation of medical devices that incorporate Artificial Intelligence and Machine Learning (AI/ML). This document sets out essential guidelines to support manufacturers, regulators and other industry stakeholders in assessing the safety, efficacy and performance of these innovative devices.
With the advance of artificial intelligence in healthcare, significant regulatory challenges arise, requiring a clear and harmonized regulatory framework. The IMDRF Playbook provides a structured approach, addressing crucial aspects such as:
Validation criteria and mitigation of risks associated with the development and use of AI/ML-based medical devices;
Requirements for the transparency and interpretability of algorithms, ensuring the trust of health professionals and users;
Continuous monitoring and adaptation of AI models, ensuring consistent performance in line with patient safety principles;
Interoperability and compliance with international regulations, ensuring data protection and system reliability.
The publication of this Playbook represents a strategic step in the harmonization of global requirements, promoting the safe and effective adoption of medical devices with AI and machine learning.
