A medical device design history file—referred to in English as the Design History File (DHF)—is the structured collection of all records demonstrating that a product was developed in accordance with the development plan and the defined requirements. ISO 13485 requires, in Clause 7.3.10, a design history file for each product type or product family that contains the relevant records or references them. It therefore constitutes a body of evidence documenting the course of development, not a collection of manufacturing specifications. Its regulatory purpose is to make the effectiveness of design controls under Clause 7.3 of the standard auditable.
Content and structure of design controls
The content follows the structure of design controls. It includes the development plan in Clause 7.3.2 with phases, responsibilities, and interfaces; the design inputs in Clause 7.3.3 with functional, performance, usability, and regulatory requirements as well as the outputs from risk management; the design outputs in Clause 7.3.4 including specifications, drawings, acceptance criteria, and safety-relevant characteristics; the records of design reviews in Clause 7.3.5; the evidence of verification in Clause 7.3.6 and validation in Clause 7.3.7; the documentation of design transfer in Clause 7.3.8; and the records of design changes in Clause 7.3.9. Traceability is a defining feature: each input must be traceable to an output and to verification or validation evidence, typically via a traceability matrix. Gaps in this chain are the most common audit finding.
Ownership, currency, and review
The design history file may be physically distributed, provided that an index clearly references the current records; in practice, it is usually a directory with references into a document control system and a requirements management system. It does not end with market launch: changes to the product, materials, software, or intended purpose generate new records that are assigned to the file so that the development status remains reconstructable at all times. Retention periods are governed by the quality management system’s record requirements and by Article 10(8) of Regulation (EU) 2017/745, which requires at least ten years after the last placing on the market and at least fifteen years for implantable devices. In the United States, the term has no longer been a regulatory term since the Quality Management System Regulation took effect on February 2, 2026, because 21 CFR Part 820 now incorporates ISO 13485 by reference; however, the substantive requirements continue to apply via Clause 7.3.10.
Distinction from technical documentation and manufacturing records
The design history file is not the technical documentation under Annex II of Regulation (EU) 2017/745. The latter is an audience-specific conformity dossier for the Notified Body and authorities, including product description, evidence of compliance with the general safety and performance requirements, risk management, clinical evaluation, and manufacturing information; the design history file is the underlying evidence base within the quality management system and typically contains significantly more raw records than the dossier. It must also be distinguished from the device master record, which consolidates the approved specifications for serial production, and from the device history record, which documents the manufacture of a specific unit or batch. In simplified terms: the design history file documents how the product was developed, the device master record how it is to be manufactured, and the device history record how it was actually manufactured.
Relevance for clinical trials
Before first use in humans, the design history file must reliably reflect the development status of the investigational device. Annex XV of Regulation (EU) 2017/745 requires, in the study documentation, information on design and manufacture as well as preclinical evidence of verification and validation; these are derived directly from the file. The clinical investigation plan must clearly identify the device configuration under investigation so that the data collected can later be assigned to the product submitted for conformity assessment.
During the study, changes to the investigational device must be recorded in the file and then assessed as to whether they affect the transferability of data already collected and whether notification of a substantial modification is required. After study completion, the clinical results feed back into validation, risk management, and change decisions, generating new entries. Full-service CROs such as Mediconomics support manufacturers and sponsors in identifying the development evidence required for study documentation, documenting device configurations traceably over the course of the study, and preparing study results for updating the development documentation.
Frequently Asked Questions (FAQ)
Does the design history file have to be a single physical dossier?
No. ISO 13485 Clause 7.3.10 allows the file to contain records or to reference them. What is required is a clear, maintained index that leads to the applicable records in each case.
Does the design history file also apply to Class I products?
Design controls under ISO 13485 apply regardless of risk class, provided the organization performs development activities. However, scope and level of detail may be scaled appropriately to the risk.
How long must it be retained?
Under Article 10(8) of Regulation (EU) 2017/745, at least ten years after the last product is placed on the market, and at least fifteen years for implantable devices; national and contractual retention periods may extend beyond this.
Regulatory References
- ISO 13485:2016, Clauses 7.3.1 to 7.3.10 – development, verification, validation, transfer, changes, design history file
- ISO 13485:2016, Clauses 4.2.4 and 4.2.5 – control of documents and records
- Regulation (EU) 2017/745, Article 10(4), (8) and (9) – technical documentation, retention, quality management system
- Regulation (EU) 2017/745, Annex II and Annex XV – technical documentation and study documentation
- 21 CFR Part 820 as amended by the Quality Management System Regulation, effective February 2, 2026
