IMDRF Publishes Final Document on Predetermined Change Control Plans for Medical Device Software
The International Medical Device Regulators Forum has published the final document IMDRF/SaMD WG/N90 FINAL: 2026, titled “Essential Principles and Content of Predetermined Change Control Plans.”
The document was prepared by the IMDRF Software as a Medical Device Working Group and focuses on the use of Predetermined Change Control Plans for medical device software.
Purpose of the Document
The document aims to share high-level principles on the use of PCCPs as a way of authorizing certain planned medical device software modifications for which regulatory authorization would otherwise be required.
It also identifies elements that manufacturers may consider when developing and documenting a PCCP to support regulatory review, while providing a broad and harmonized framework that jurisdictions may apply within their own regulatory systems.
Scope
The document applies to software that meets the definition of a medical device, referred to as medical device software.
IMDRF clarifies that the document is not intended to replace any jurisdiction’s laws or regulations, establish regulatory requirements for PCCPs, define specific acceptable change types, or serve as regulation or guidance across jurisdictions. It also notes that not all jurisdictions may accept PCCPs or similar plans for regulatory review.
What Is a PCCP?
A PCCP allows manufacturers to seek authorization to implement planned changes to medical device software while maintaining continued safety and effectiveness.
According to IMDRF, a PCCP describes the specific planned changes, the change plan or protocol for implementing and controlling those changes using predefined acceptance criteria, and the assessment of impacts from those changes.
Essential Principles
IMDRF identifies five essential principles for robust PCCPs:
focused and bounded;
risk-based;
evidence-based;
transparent;
based on a Total Product Lifecycle perspective.
These principles are intended to ensure that planned software changes remain within the original intended use or intended purpose, are supported by appropriate evidence, are managed through risk management and remain transparent to intended users and regulatory bodies.
Core Elements of a PCCP
The document explains that a well-formulated PCCP generally consists of three interconnected elements:
Description of Changes — describing the planned software changes and the rationale for each change;
Change Plan — describing verification and validation activities, predefined acceptance criteria, deployment procedures and communication to users;
Impact Assessment — evaluating the anticipated benefits and risks of individual and cumulative changes, including mitigations.
The level of detail should be proportionate to the risk or complexity of the planned change and sufficient for regulatory assessment.
Quality Management, Risk Management and Traceability
IMDRF highlights that PCCPs should be developed and managed within the manufacturer’s existing quality management system, including risk management and change management processes.
Version control is also important, as regulatory bodies and manufacturers need to understand which version of the PCCP was authorized and how future revisions are tracked.
Benefits and Challenges
The document states that PCCPs may enable faster access to improved medical device software, support healthcare system efficiency, reduce the need for multiple regulatory submissions and encourage early interaction between manufacturers and regulatory authorities.
At the same time, IMDRF identifies challenges, including more complex submissions, additional review complexity for regulators, traceability and implementation requirements, and different levels of PCCP adoption internationally.
Impact on Medical Device Software Manufacturers
For medical device software manufacturers, the IMDRF document is highly relevant for planning future software modifications in a structured and regulator-ready manner.
Manufacturers should pay particular attention to:
defining planned software changes clearly;
keeping PCCP changes within the original intended use or intended purpose;
integrating PCCPs into QMS, risk management and change management processes;
documenting verification and validation activities;
establishing predefined acceptance criteria;
assessing individual and cumulative change impacts;
managing version control and traceability;
planning user communication and labeling updates;
considering cybersecurity and interoperability impacts;
accounting for differences in jurisdictional acceptance of PCCPs.
For manufacturers developing SaMD and other medical device software, the document reinforces the importance of planning software evolution across the Total Product Lifecycle while maintaining safety, effectiveness and regulatory confidence.
