What Are Files in Medical Device Regulatory Affairs?

The term “file” frequently appears in medical device regulation.

Examples include the Design History File (DHF), the Risk Management File (RMF), the Usability Engineering File (UEF), and the Complaint File (as referenced in FDA regulations). These files represent critical documentation structures that organize regulatory activities and evidence of compliance.

The Purpose of Files

Why are files necessary in medical device regulation?

Files are compiled and organized documents and records designed to facilitate systematic investigation and verification by regulatory inspectors and auditors from third-party conformity assessment bodies. The primary purpose is to demonstrate compliance with applicable regulatory requirements and international standards in a clear, traceable, and efficient manner.

For instance, all matters related to risk management in medical device design must be compiled within the Risk Management File. When inspectors or auditors examine this file, they can quickly verify that risk management activities have been conducted in accordance with applicable regulatory requirements and international standards (such as ISO 14971), and that all records are appropriately maintained and documented. Similarly, the Design History File serves as a comprehensive compilation that traces the entire design and development lifecycle, ensuring that design control activities required by FDA regulations (21 CFR Part 820, Subpart C) and international standards (ISO 13485) have been properly executed and documented.

Therefore, files are instrumental tools used to confirm organizational conformity with applicable international standards and regulatory requirements.

The Hierarchical Structure of Files

It is important to understand that files have an inherent hierarchical inclusion relationship.

The Risk Management File is included within the Design History File, and the Usability Engineering File is included within the Risk Management File. This nested structure ensures that all risk and usability considerations are documented within the broader design history documentation.

Files as Documentation Indices Rather Than Physical Containers

Files are not created as physical binders with documents bound together in paper format. Rather, a file serves as a structured index or reference system that points to relevant records and documents maintained elsewhere in the organization.

For example, design documentation often contains discussions and decisions related to multiple regulatory domains simultaneously. A single design document might include narrative or analysis related to risk management, usability engineering, and design controls all within the same section or chapter. The Risk Management File and Usability Engineering File do not replicate this content; instead, they provide cross-references or “pointers” that indicate specific document titles, section numbers, or page references where relevant information can be located.

This approach—using files as indexing and cross-reference tools rather than as comprehensive collections of physical documents—provides several practical advantages. It eliminates redundant document management, reduces storage requirements, and ensures that regulatory evidence remains traceable back to original source documents with clear documentation of where and how design and risk management decisions were made.

Therefore, understanding files as systematic reference and organization tools—rather than as mere repositories of documents—is essential to effective regulatory compliance management in medical device organizations.