Device History Record (DHR) is a comprehensive compilation of records detailing the production history of a finished medical device. Mandated by FDA regulation 21 CFR Part 820.184, the DHR includes manufacturing dates, quantities produced and released, acceptance records, primary identification labels, and unique device identifiers (UDI). It ensures that each device or batch is manufactured in compliance with the specifications outlined in the Device Master Record (DMR).
The DHR is crucial in medical device manufacturing for ensuring quality, traceability, and regulatory compliance. It supports audits, deviation management, risk mitigation, and product recalls by documenting every step of the manufacturing process.
While the FDA uses the term DHR, ISO 13485:2016 requires equivalent records under its clauses on production realization.
The DHR aims to ensure compliance with quality processes during production, and it aligns with the Device Master Record (DMR) and Design History File (DHF). The DMR provides the manufacturing blueprint, while the DHF details the design and development process. Together, all these documents ensure consistency, compliance, and quality from design to production.
An electronic Device History Record (eDHR) is the digital equivalent of a DHR, simplifying data management and retrieval while reducing manual errors.
QMS software enhances the management of DHRs by enabling efficient and accurate handling in an electronic format. SimplerQMS, for instance, provides comprehensive QMS software tailored for medical device companies. It facilitates seamless DHR management, integrates with DMR and DHF processes, and enhances operational efficiency.
To see how SimplerQMS can transform your DHR management and streamline broader QMS processes, book a demo with a Quality Solutions Expert today.
What Is a Device History Record (DHR)?
A Device History Record (DHR) is defined by the FDA as a compilation of records containing the production history of a finished device. DHR is a regulatory document required by the FDA under 21 CFR Part 820.184 that directly details the production history of a finished medical device.
According to FDA requirements, the DHR includes or references information such as the location of production processes, manufacturing dates, the quantity produced, the quantity released for distribution, acceptance records confirming adherence to acceptance criteria, and the primary identification label and labeling used for each production unit.
The DHR ensures traceability and regulatory compliance by detailing each step in the manufacturing process of a medical device.
The DHR serves as proof that a device was manufactured following the Device Master Record (DMR). It is important to note that the Device History Record (DHR) differs from the Device Master Record (DMR), which specifies the manufacturing processes and procedures, and the Design History File (DHF), which captures the details of the device’s design process.
As an integral part of the regulatory and quality management framework for medical devices, the DHR ensures compliance and traceability throughout production.
Why is a Device History Record Important?
The Device History Record (DHR) is an essential component of quality management, serving multiple functions that ensure compliance, traceability, and quality assurance in medical device manufacturing. Key reasons why the DHR is essential are listed below.
- Nonconformance/Deviation Management: By providing a detailed account of the manufacturing process for each device, these records are instrumental for investigating nonconformance/deviations or discrepancies in product quality, often referred to as the “DHR investigation process.” By examining the DHR, manufacturers can quickly pinpoint and address the root causes of issues, preventing further complications.
- Risk Mitigation: In the event of product recalls, customer complaints, or other issues, the DHR facilitates the traceability of affected batches, enabling swift and targeted responses. This capability not only enhances patient safety but also ensures business continuity.
- Audits and Compliance: DHR plays a vital role in ensuring regulatory compliance by providing auditors with documented evidence that a medical device has been manufactured following relevant requirements.
- Customer Complaints: Investigations and root cause analyses can be conducted effectively using the detailed information stored in the DHR, facilitating swift resolution of issues.
- Quality Assurance: DHRs contribute to the production of quality products that meet customer and regulatory requirements as these records reflect the collective batch records ensuring requirements are met.
- Product Recalls: Possible product recalls that lead to cost and liabilities are minimized since DHRs demonstrate an assurance that all batches of a product have been manufactured and tested in compliance with requirements, companies can safeguard their reputation and mitigate financial risks.
- Traceability: In terms of product recalls, batch records are easily pulled out from DHRs to provide efficient investigation and traceability activities.
What Does a Device History Record Include?
A device history record typically includes the following.
- Manufacturing Date: This specifies when production occurred.
- Quantity Manufactured: This specifies the number of units manufactured.
- Quantity Released for Distribution: This specifies the number of medical devices or units that have successfully passed all required quality checks, inspections, and testing during production and are approved for shipment to customers or distribution centers.
- Acceptance or Rejection Records: These records document whether the device or its components met the required quality control requirements during and after production following the Device Master Record.
- Primary Identification Label and Labeling Records: These include copies of all device labels and their control numbers, ensuring the traceability of each unit.
- Device Identification and Control Numbers: Unique identifiers assigned to each device facilitate tracking and, if necessary, recall procedures.
- Actual Manufacturing Process Data: Examples include test results, environmental conditions during production, and the names of operators involved. Such data ensures that every step of the manufacturing process is thoroughly documented and reviewable.
The exact contents of a DHR vary depending on the complexity of the device, specific regulatory and customer requirements, and the manufacturer’s internal procedures. An example of a DHR index or template might include sections labeled with each of these categories, organized in a manner that allows quick access and review to ensure all manufacturing criteria have been met and documented.
For example, in SimplerQMS, a single document, such as a product release note, can be linked to other relevant documents for better tracking and management.
The image below shows an example of a product release note, part of the DHR, detailing batch, packaging, lab controls, and SOPs for the lot.
What Are the FDA Requirements for a Device History Record?
The FDA 21 CFR Part 820 mandates specific requirements for a Device History Record (DHR) under 21 CFR Part 820.184. FDA 21 CFR Part 820 regulation stipulates that each DHR must demonstrate that each unit, lot, or batch of a device was manufactured following the Device Master Record (DMR).
Per section 820.184 device history record:
“Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.”
The Device History Record (DHR) must include key information to ensure traceability and regulatory compliance. It should document the manufacturing dates, including the start and end dates for a batch, lot, or unit, which is important for recalls or investigations. The quantity manufactured is recorded to track production volume and manage inventory. The quantity released for distribution shows how many units passed quality checks and were approved for release. Acceptance records include inspection and testing results, confirming the device meets the specifications in the Device Master Record (DMR). The primary identification label and packaging are also documented to ensure proper labeling, which is required for compliance. Lastly, the unique device identifier (UDI) or universal product code (UPC) is recorded to track devices throughout their lifecycle, supporting post-market surveillance, recalls, and adverse event reporting.
In the context of manufacturing, the term “lot history record” is often used interchangeably with DHR, especially when referring to specific batches or lots of devices. A lot history record (LHR) is a detailed document that provides a complete history of a specific batch or lot of medical devices throughout its production. This is a component of the Device History Record (DHR) that ensures traceability and accountability for the devices produced in that lot. The LHR includes all pertinent information related to the manufacturing, quality control, and testing of the devices in a particular lot.
Manufacturers must ensure that these records are complete, accurate, and readily accessible during FDA inspections or audits. Common pitfalls in DHR management include incomplete acceptance criteria documentation and missing signatures, which can lead to compliance issues. Furthermore, manufacturers must have documented procedures for creating, updating, and preserving DHRs.
To mitigate these risks and streamline compliance, many manufacturers implement Quality Management System (QMS) software or document management software solutions. These tools automate the creation and maintenance of DHRs, ensuring that all necessary data is captured accurately and is easily retrievable for audits and inspections. This not only helps in maintaining compliance but also enhances the efficiency of the manufacturing process.
What Are the ISO 13485 Requirements Related to Device History Records?
ISO 13485:2016 does not explicitly reference the term “Device History Record” (DHR), but it mandates the maintenance of detailed production, service provision, and traceability records that closely align with the concept of a DHR. Specifically, clauses 4.2, 7.5.8, 7.5.9, and 7.3.10 are related to DHR.
Clause 4.2 Documentation Requirements covers how records (including production records) must be controlled and maintained.
Clause 7.5 Production and Service Provision, particularly in the sub-clauses on process controls, identification, and traceability (7.5.8 and 7.5.9). These sub-clauses ensure that each device can be readily traced through the manufacturing process, supporting safety, quality, and regulatory compliance objectives.
Clause 7.3.10 Design and development files of ISO 13485:2016 require organizations to maintain a design and development file for each medical device type or family, containing or referencing records that demonstrate conformity to design and development requirements and any related changes.
These records serve a similar function to the DHR by providing documented proof of compliance with design and regulatory requirements, ensuring that each device is manufactured in accordance with established processes and quality requirements.
While FDA and ISO 13485 have different terminologies in terms of these types of records, FDA regulations and ISO standards share the same goal – to ensure patient safety by maintaining a comprehensive, traceable history of each device’s production.
An example of how an organization can simultaneously meet both FDA and ISO requirements is by using QMS software, such as SimplerQMS. QMS software allows you to store DHRs in a manner that complies with FDA regulations while also organizing them following ISO 13485 standards. This dual compliance is achieved by maintaining the same documents in different archives within the QMS, each tailored to meet the specific regulatory requirements of the FDA and ISO. This approach enhances both compliance and efficiency while ensuring traceability throughout the manufacturing process.
In SimplerQMS, you can create folder structures and name them accordingly, for example, DHF, DHR, DMR, and Technical File. Inside these folders, different documents can be stored. Each document has metadata, where you can add a “Label” that links it to the folder where it is visible. Adding multiple labels allows the document to be visible in all the relevant folders.
How Does a DHR Differ from a Device Master Record (DMR) and a Design History File (DHF)?
A Device History Record (DHR), Device Master Record (DMR), and Design History File (DHF) play distinct roles in the lifecycle of a medical device.
Device history records are the actual production history of each batch or unit of a device, providing a detailed record of the manufacturing process, including dates, quantities, and compliance with acceptance criteria. This record serves as proof that the device was manufactured according to the specifications and other requirements outlined in the DMR.
The device master record contains the complete set of manufacturing instructions and specifications for a device. It includes or references the procedures and specifications for producing, assembling, and testing a device. It ensures that all production units are built consistently and in compliance with the requirements.
A design history file is a compilation of documents that describe the design and development history of a device. It includes all documentation that demonstrates the design was developed according to the planned design process and customer and regulatory requirements.
Together, these documents ensure that medical devices are designed appropriately, manufactured correctly, and meet all necessary customer, regulatory, and quality requirements throughout their lifecycle. Each record, from design through production, supports the next, ensuring comprehensive traceability and accountability in medical device manufacturing.
To explore the differences and relations between DHR, DMR, and DHF, read out our dedicated article.
What is an Electronic Device History Record (eDHR)?
An electronic Device History Record (eDHR) is the digital counterpart of the traditional paper-based Device History Record (DHR). It serves the same purpose of documenting the production history of a medical device but in an electronic format. The eDHR system captures, manages, and stores all manufacturing data electronically, helping to reduce human errors, streamline data entry, and simplify audit and inspection processes.
The use of eDHR systems is supported by FDA guidance on electronic records, particularly in 21 CFR Part 11, which establishes the criteria for ensuring that electronic records and signatures are trustworthy, reliable, and equivalent to paper records. This regulation ensures that electronic documents, including eDHRs, are handled in compliance with regulatory requirements.
The advantages of using an eDHR include improved traceability and easier access to records, faster data retrieval during inspections or audits, and enhanced capabilities for analyzing manufacturing data to drive continuous improvement. Furthermore, eDHR systems enable real-time data capture and validation, which significantly boosts the efficiency of quality management processes while ensuring compliance with regulatory requirements.
What Is the Role of QMS Software in DHR Management?
Quality Management System (QMS) software plays a vital role in managing DHRs by providing a centralized platform for document control and management. Key features such as version control and secure access are essential for preserving the integrity and confidentiality of DHRs. QMS software also automates workflows for approvals and signoffs, reducing manual processing time and improving record accuracy.
Additionally, QMS software facilitates the linking of design changes, the Device Master Record (DMR), and the DHR, ensuring that any updates in design or production are accurately reflected in the DHR, thereby maintaining compliance and traceability. Audit trails, a critical feature of QMS software, offer transparent and traceable records of all actions and changes, which is invaluable during regulatory inspections and audits.
Modern eQMS solutions support the management of electronic DHRs. These systems improve data collection and retrieval, simplifying compliance with regulations like FDA 21 CFR Part 820 and ISO 13485, and enabling quick and accurate access to production records.
SimplerQMS provides eQMS solution for medical devices that includes robust document management and workflow automation capabilities, ensuring compliance with various requirements. SimplerQMS supports a wide range of QMS processes that can link DMRs and DHF, for instance, training management, CAPA, and audit management, this comprehensive approach helps medical device companies meet requirements such as FDA 21 CFR Part 820, ISO 13485:2016, and FDA 21 CFR Part 11, among others.
For companies aiming to enhance DHR management efficiency and streamline broader QMS processes, SimplerQMS offers significant benefits. Discover how SimplerQMS can improve operational efficiency and ensure regulatory compliance with solutions tailored to your needs – book a demo with our Quality Solutions Expert today.
