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Guidance on machine learning-enabled medical devices (MLMD)

Medical devices regulation

Published by Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada.

In this document, the term PCCP (predetermined change control plan) describes a plan, proposed by a manufacturer, that specifies:

• certain planned modifications to a device

• the protocol for implementing and controlling those modifications and

• the assessment of impacts from modifications.

The guidance contains key guidance on predetermined change control plans (PCCPs) for MLMDs.

1. Focused and Bounded: PCCP should describe specific changes that a manufacturer intends to implement.

2. Risk-based: The intent, design, and implementation of a PCCP are driven by a risk-based approach that adheres to the principles of risk management.

3. Evidence-based: Manufacturers should demonstrate that benefits outweigh the risks throughout the Total Product Life Cycle (TPLC) before and after the changes specified in the PCCP are implemented.

4. Transparent: Best practice is to provide clear and appropriate information and detailed plans for ongoing transparency to users and other stakeholders.

5. Total Product Lifecycle Perspective: Elevate the quality and integrity of a PCCP by continually considering the perspectives of all stakeholders and risk management practices.

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