Every batch of medical devices you produce has its own unique story. It starts with specific lots of raw materials, moves through a series of production steps on certain equipment, and ends with final quality checks before being shipped. This entire manufacturing journey must be captured in one place: the Device History Record (DHR). Think of the DHR as the official biography for each production run. It provides the critical traceability needed to investigate any issues, manage recalls, and ensure patient safety. Without this detailed record, you can’t prove your device was made correctly, leaving your company exposed to significant compliance risks.
Key Takeaways
- Treat the DHR as Your Production Fingerprint: This collection of records is your non-negotiable proof that a specific device batch was built according to its Device Master Record (DMR). It’s the first thing auditors check for compliance and your go-to resource for investigating any post-market issues.
- Connect the DHF, DMR, and DHR: Remember the relationship this way: the Design History File (DHF) documents why the device was designed, the Device Master Record (DMR) provides the instructions for how to build it, and the Device History Record (DHR) proves you did build it correctly.
- Build an Audit-Ready System: Don’t scramble for records during an inspection. Establish clear SOPs, train your team on their documentation duties, and use a centralized system (like an eDHR) to ensure your DHRs are always complete, accurate, and immediately accessible.
What is a Device History Record (DHR)?
Think of the Device History Record, or DHR, as the complete manufacturing story for a specific batch, lot, or unit of your medical device. It’s the official compilation of records that proves your device was built according to its blueprint—the Device Master Record (DMR). Every step, from the materials used to the final inspection, is documented here. This isn’t just about keeping good notes; it’s about creating a verifiable trail that shows you followed your own established procedures and met all quality standards.
The DHR is your proof of compliance. If an auditor ever asks, “How do you know this batch of devices was made correctly?” your DHR is the answer. It contains all the production records, test results, and labeling information for that specific group of devices. Essentially, it’s a comprehensive collection of documents that confirms each device was manufactured in line with its approved design and specifications. Without a complete and accurate DHR for every batch, you can’t demonstrate that your production process is under control, which is a cornerstone of FDA compliance.
The DHR’s Role in Medical Device Manufacturing
In the day-to-day world of manufacturing, the DHR is your go-to file for quality control and traceability. It acts as the central production record, allowing you to track a device from the assembly line all the way through the supply chain. If a customer reports an issue or a component fails, the DHR is your first stop. It helps you pinpoint the exact batch affected, investigate the root cause, and manage any necessary recalls efficiently. This level of traceability is critical not only for resolving problems but also for protecting patient safety and maintaining trust in your products.
The Official Definition: What Regulations Require
The FDA doesn’t just suggest you keep a DHR; it mandates it. The requirement is spelled out in 21 CFR Part 820.184, which is part of the Quality System Regulation. According to the FDA, manufacturers must maintain a DHR for each batch, lot, or unit to show it was produced in accordance with the Device Master Record (DMR). This record must include key details like the dates of manufacture, the quantity of devices produced, the quantity released for distribution, and all the acceptance records that confirm the device is ready for market. It’s the official paper trail that proves your compliance.
What Goes into a Device History Record?
Think of the Device History Record (DHR) as the complete production story for a batch, lot, or single unit of your medical device. It’s the official log that proves each device was manufactured according to your master plan—the Device Master Record (DMR). While the specifics can vary depending on your device, every DHR needs to contain certain core elements to satisfy regulators and ensure traceability. This isn’t just a single document but a compilation of records that, together, provide a clear and detailed history of a product’s journey through your facility. It’s your definitive proof that you followed your own procedures and that the final product meets all specifications.
Compiling this record isn’t just about checking a box for the FDA; it’s about creating a detailed, accurate, and accessible history that confirms the quality and safety of your product from the factory floor to the end user. This documentation is your first line of defense during an audit and an essential tool for investigating any customer complaints or non-conformances. A complete DHR demonstrates that you have control over your manufacturing processes. It should capture everything from the dates of production and the results of quality control tests to the specific labels applied and the final quantity of units shipped out the door. Without this comprehensive record, you can’t prove compliance or effectively manage post-market activities.
Production Dates and Lot Information
First and foremost, your DHR must capture the fundamental details of the production run. This includes the specific dates of manufacture for the lot or batch. You’ll also need to document the quantity of devices produced during that run and, just as importantly, the quantity approved for distribution. This information creates a clear timeline and scope for each production cycle. Think of it as the “when” and “how many” of your device’s story. This data is essential for tracking your device’s lifecycle and is one of the first things an auditor will look for to verify your production history and inventory records.
Quality Control Checks and Test Results
This is where you prove that you followed your own recipe—the Device Master Record (DMR). The DHR must include all the records of quality control checks performed during production. This means documenting acceptance records, test results, inspection data, and any other verification activities that confirm the device meets its specifications. It should also include details about the production environment, if relevant, and the primary identification of the equipment used. This section provides the objective evidence that your device was built correctly and passed all necessary quality gates before being released for sale, ensuring accountability throughout the manufacturing process.
Device Labeling and UDI Records
Every DHR must contain the labeling for each production unit. This includes copies of the final, approved labels and any package inserts. A critical piece of this is the Unique Device Identifier (UDI) or other device identification codes applied to the device. The UDI is a unique numeric or alphanumeric code that acts as the device’s fingerprint, allowing it to be tracked throughout its entire distribution and use. Having a clear record of the specific labels and UDIs assigned to a batch is non-negotiable for market traceability and is a key component of FDA labeling regulations.
Unit Quantities and Distribution Details
Finally, the DHR ties everything together by documenting the final counts. It must state the total quantity of devices manufactured in the batch and the exact quantity of devices that were distributed into the market. This information provides a clear and final tally of the production run, which is crucial for inventory management, reconciliation, and post-market activities. In the event of a complaint investigation or a recall, this data allows you to quickly determine how many units from a specific lot are in the field, helping you manage risk and protect public health efficiently.
Why Your DHR is Non-Negotiable
Think of the Device History Record as more than just a folder of paperwork. It’s the complete story of your product, from the moment it was an idea to the day it shipped out the door. Maintaining a thorough DHR isn’t just about checking a box for the FDA; it’s a fundamental practice that protects your customers, your reputation, and your bottom line. It’s your proof that you’ve done everything right.
When things are running smoothly, the DHR works quietly in the background. But when a question arises—whether from a customer, a partner, or a regulator—it becomes your most valuable asset. A missing or incomplete DHR can lead to warning letters, product holds, and serious legal trouble. Let’s break down exactly why this documentation is an absolute must-have for any medical device manufacturer.
Meet FDA Requirements and Stay Compliant
First and foremost, maintaining a DHR is a legal requirement. The FDA defines a Device History Record as “a compilation of records containing the production history of a finished device.” This isn’t a suggestion; it’s a mandate under the Quality System Regulation, specifically FDA 21 CFR Part 820. This rule requires every manufacturer to establish and maintain a DHR for each batch, lot, or unit to demonstrate that the device was manufactured in accordance with the Device Master Record (DMR).
Failing to comply can result in significant penalties, including warning letters, fines, and even facility shutdowns. A complete and accurate DHR is your first line of defense during an inspection, proving that you have robust processes in place and are committed to regulatory compliance. It shows inspectors that you have control over your manufacturing and can account for every device you produce.
Ensure Product Quality and Traceability
Beyond compliance, the DHR is a powerful tool for quality control. It serves as the official production record for your medical devices, allowing you to track every component and process from start to finish. This detailed history ensures that every single device meets the required quality standards before it ever reaches a patient. If a deviation occurs during production, the DHR provides the data needed to catch it immediately.
This level of traceability is essential for investigating any issues that may arise after a product is on the market. DHRs help companies quickly investigate device complaints and figure out why they happened. With a complete DHR, you can trace a problem back to a specific batch of raw materials, a piece of equipment, or a particular shift, making it easier to implement corrective actions and prevent future occurrences. This is a core function of any effective Quality Management System.
Manage Risk and Prepare for Recalls
No one wants to think about a product recall, but being prepared is a critical part of risk management. In the event of a product failure or safety concern, your DHR is indispensable. It contains the precise information needed to identify the scope of the problem, pinpointing the exact batch, lot, or unit affected. This is vital for executing swift and targeted medical device recalls.
Without a detailed DHR, you might be forced to recall an entire product line instead of just a small, isolated batch. The financial and reputational damage of such a broad action can be devastating. A well-maintained DHR minimizes this risk by providing the data to make informed, precise decisions. It protects patients from potential harm while also protecting your company from unnecessary liability and business disruption.
DHR, DMR, and DHF: How They Fit Together
If you’re feeling a bit lost in the alphabet soup of DHR, DMR, and DHF, you’re not alone. These three critical files are the backbone of your medical device documentation, but they each serve a distinct purpose. Think of them as interconnected chapters in your product’s life story, each one building on the last. Understanding how they relate to one another is fundamental to building a compliant and efficient quality management system. Getting this relationship right isn’t just about checking a box for the FDA; it’s about creating a clear, traceable history for every device you produce. This traceability is your best defense during an audit and your most valuable tool for managing quality control. The DHF explains why your device was designed, the DMR provides the instructions for how to build it, and the DHR proves that you did build it according to those instructions. Let’s break down how they connect and why each one is indispensable for your operations.
Connecting the DHR to the Device Master Record (DMR)
The Device Master Record (DMR) is your device’s official recipe book. It contains every single instruction, specification, and drawing needed to manufacture a consistent and safe product. This includes everything from material specs and equipment settings to labeling and packaging procedures. The Device History Record (DHR), on the other hand, is the proof that you followed that recipe for a specific batch, lot, or unit. It’s the production logbook that documents the entire manufacturing journey. The DHR demonstrates that a device was made in accordance with the Device Master Record. If the DMR is the blueprint, the DHR is the completed construction report confirming the blueprint was followed precisely.
Linking the DHR to the Design History File (DHF)
While the DHR and DMR focus on manufacturing, the Design History File (DHF) tells the story of how your device was conceived and developed. The DHF is a compilation of all the records that show how the design was created, from initial user needs and concepts to the final, validated design output. It’s the evidence behind why your device is designed the way it is. The DHR doesn’t directly link to the DHF’s early stages, but it serves as the final proof that the validated design—which is detailed in the DHF and translated into the DMR—was successfully manufactured. The DHF establishes the design, and the DHR confirms that the manufactured product meets that established design control process.
Understanding the Document Hierarchy
The easiest way to remember the relationship between these three files is to think of them in a logical sequence: design, instruct, and record.
- Design History File (DHF): This comes first. It documents how the device was designed and developed from an idea into a finished concept.
- Device Master Record (DMR): This comes next. It’s the comprehensive set of instructions on how to build the device based on the final design from the DHF.
- Device History Record (DHR): This is the final step in the chain. It’s the collection of records that proves a specific device or batch was actually built according to the instructions in the DMR.
Together, these three files provide complete traceability from the initial design concept all the way to a finished product in the market.
Which Regulations Govern the DHR?
Keeping a detailed Device History Record isn’t just a best practice; it’s a strict requirement mandated by regulatory bodies around the world. If you plan to manufacture and sell medical devices, you need to know which rules apply to you. While the specific terminology can vary, the core principle remains the same: regulators want a complete, traceable production history for every device that reaches the market. This ensures that if a problem arises, you can quickly investigate the root cause and protect public health.
Understanding these regulations is the first step toward building a compliant and effective quality management system. The three main frameworks that govern DHR documentation are the FDA’s Quality System Regulation, the ISO standard for medical device quality management, and the European Medical Device Regulation. Each has its own set of expectations, but they all point toward the need for meticulous record-keeping that proves your devices were made according to their approved specifications.
FDA’s 21 CFR Part 820.184
For any company selling medical devices in the United States, the FDA’s regulations are non-negotiable. The specific rule that defines the DHR is 21 CFR Part 820.184. The FDA officially describes the DHR as a “compilation of records containing the production history of a finished device.”
The primary purpose of this record is to demonstrate that each batch, lot, or unit was manufactured in accordance with the Device Master Record (DMR). Think of it as the final report card for your production run. It proves you followed your own approved recipe and processes every single time. An incomplete or inaccurate DHR is a major red flag for FDA inspectors and can lead to significant compliance issues.
ISO 13485:2016 Standards
While the FDA’s rules are specific to the U.S. market, ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. Interestingly, the standard doesn’t use the exact term “Device History Record.” However, it absolutely requires the same level of documentation.
ISO 13485 mandates that organizations maintain records to provide evidence of conformity to requirements and to ensure traceability. This means you must be able to track every component, every production step, and every quality check for each device. In practice, the collection of documents you create to meet this requirement functions exactly like a DHR. If your company is ISO 13485 certified, you are already generating the necessary records.
European Medical Device Regulation (MDR 2017/745)
If you intend to sell your devices in the European Union, you must comply with the European Medical Device Regulation (MDR). Similar to ISO 13485, the EU MDR places a heavy emphasis on traceability and comprehensive documentation throughout the entire device lifecycle. It requires manufacturers to have a robust quality management system that can prove every device was produced safely and effectively.
The DHR is a critical tool for meeting these MDR requirements. It provides the detailed production evidence needed for quality control, post-market surveillance, and liability management. By maintaining a thorough DHR for each device, you create the paper trail necessary to demonstrate compliance with the EU’s stringent standards and ensure your product can legally be placed on the European market.
Common DHR Compliance Challenges to Anticipate
Maintaining a perfect Device History Record for every single device or batch is a big job, and a few common hurdles can trip up even the most diligent teams. The key is to know what these challenges are so you can build processes to prevent them from happening in the first place. From messy data to last-minute audit prep, these issues are completely manageable with the right approach. Let’s walk through some of the most frequent compliance challenges and how you can get ahead of them. By anticipating these potential pitfalls, you can ensure your DHRs are always accurate, complete, and ready for inspection, protecting both your product quality and your company’s reputation.
Ensuring Data Integrity and Complete Records
Your DHR is the official story of how a device was made, and every detail must be accurate and accounted for. A major challenge is ensuring the data within the DHR is not only present but also correct. Simple human error can lead to discrepancies, like an ingredient amount that doesn’t match the official recipe in the Device Master Record (DMR) or a missing Quality Assurance form. These aren’t just minor clerical errors; they can trigger compliance issues. The goal is maintaining complete records that are free of contradictions, gaps, or inaccuracies, proving that each device was manufactured exactly as intended.
Closing Staff Training and Knowledge Gaps
Even the most sophisticated quality management system is only as effective as the people using it. Incomplete records, missing signatures, or forgotten quality checks often stem from gaps in team training. If staff members don’t fully understand the “why” behind each step of the DHR process, they’re more likely to make mistakes. Consistent and thorough training is essential to ensure every person involved in production knows their specific responsibilities and understands the critical DHR requirements. When your team is confident in their roles, they become your first line of defense in maintaining compliance and product quality.
Preparing Your Systems for an Audit
An FDA inspection is not the time to discover your DHRs are disorganized or hard to find. Auditors need to see documented proof that your devices were manufactured according to all regulations, and they won’t have time to wait while you search for misplaced files. A significant challenge for many companies is keeping their records in a constant state of audit-readiness. Having all DHR information organized and easily accessible in a centralized system—whether digital or paper—makes audits smoother and demonstrates a culture of quality. This proactive approach saves you stress and shows inspectors that you have robust controls in place.
How to Organize Your DHR Documentation
Having all the required information for your DHR is a great first step, but how you organize it is just as critical. A disorganized system can lead to lost records, incomplete data, and a major headache during an audit. The goal is to create a clear, logical, and easily accessible system that works for your team and stands up to regulatory scrutiny. Think of it as building the framework that holds all your critical production data together.
A well-organized DHR system isn’t just about tidiness; it’s a fundamental part of your quality management strategy. It ensures that any team member can quickly find specific information, whether it’s to investigate a customer complaint or pull records for an FDA inspector. Getting your documentation in order reduces the risk of human error, saves valuable time, and makes the audit process significantly smoother. Let’s walk through the key steps to building a DHR documentation system that is both compliant and efficient.
Choose Your System: Electronic vs. Paper
The first decision you’ll make is whether to stick with a traditional paper-based system or move to a digital one. While paper records are still technically compliant, they come with risks like physical damage, loss, and challenges with storage and retrieval. Many companies are now using electronic DHR (eDHR) systems to manage these records digitally. An eDHR can improve accuracy, streamline data entry, and ensure everyone is working from the most current information. This digital approach makes it far easier to search, share, and secure your records for the long haul.
Implement Version Control and Data Security
Whether you choose paper or an electronic system, controlling your documents is non-negotiable. Version control ensures that your team is always using the correct, most up-to-date forms and procedures, preventing costly mistakes that can happen when an old document is accidentally used. Just as important is data security. Your DHR contains sensitive proprietary information about your manufacturing process. You need a system that protects this data from unauthorized access or accidental deletion, ensuring its integrity is maintained throughout the device’s lifecycle. This is where a robust digital system often has a clear advantage.
Integrate the DHR with Your Quality Management System
Your DHR doesn’t exist in a silo. It’s deeply connected to other critical quality documents, including your Device Master Record (DMR) and Design History File (DHF). Integrating your DHR into a comprehensive Quality Management System (QMS) is the most effective way to manage these relationships. A QMS acts as a central hub, linking production records to design specifications, test results, and quality checks. This creates a single source of truth, automates workflows, and ensures that your records are always complete, consistent, and ready for inspection. It turns your documentation from a simple record-keeping task into a powerful quality assurance tool.
What to Expect During a DHR Inspection
An FDA inspection can feel daunting, but it doesn’t have to be. Think of it as an open-book test where your Device History Records are the answer key. When an inspector arrives, they’re looking for a clear, organized, and complete story of your manufacturing process for each batch, lot, or unit. They want to see that you’re following your own procedures and that your records prove it. Being prepared is your best strategy for a smooth and successful audit. It all comes down to knowing what inspectors look for and proactively addressing common issues before they ever set foot in your facility.
What FDA Inspectors Focus On
When an FDA inspector reviews your DHRs, they are essentially verifying that you built your device according to its approved blueprint, the Device Master Record (DMR). They will look for specific, concrete details to confirm this. Expect them to check for the dates of manufacture, the quantity of devices produced, and the quantity released for distribution. They’ll also scrutinize your records for evidence of acceptance, ensuring each device meets all quality criteria. The inspector will verify that the primary identification label and any other labeling used are documented correctly, along with any unique device identification (UDI) or control numbers. Your DHR is the official proof of compliance, demonstrating that you followed every required step.
Prepare for Audits and Avoid Common Pitfalls
The best way to handle an audit is to be ready for one at all times. This means ensuring your DHRs are consistently complete, accurate, and easily accessible. One of the most common pitfalls is simple human error—things like missing signatures, incomplete quality check documentation, or dates that don’t line up. These small mistakes can lead to major compliance headaches. To avoid this, make it a habit to double-check that all information in the DHR perfectly matches the Device Master Record. Implementing a robust Quality Management System can help you build these cross-checks directly into your workflow, catching potential errors before they become a problem during an inspection.
Your Checklist for Effective DHR Management
Staying on top of your Device History Records is about more than just paperwork; it’s about building a reliable system that guarantees quality and keeps you prepared for scrutiny. A strong DHR management strategy protects your company, ensures product safety, and makes audits much less stressful. It all comes down to having clear processes and using the right tools for the job.
Think of your DHR as the official biography for each batch of your medical device. It’s the collection of documents that proves a device was made correctly, following all the rules laid out in its Device Master Record (DMR). To manage this effectively, you need to focus on two key areas: establishing clear internal guidelines for your team and leveraging technology to streamline the entire process. This approach helps you maintain consistency, reduce human error, and create a culture of quality from the ground up.
Develop Clear SOPs and Train Your Team
Your first step is to create clear and detailed Standard Operating Procedures (SOPs) for every part of the DHR process. These instructions should leave no room for ambiguity, outlining exactly who is responsible for recording data, when it needs to be recorded, and where it should be stored. Your team needs to understand that their work is essential for proving compliance. Consistent training ensures everyone knows their role and appreciates the importance of maintaining accurate records. The goal is to make sure your DHRs are always complete, correct, and easy to access for FDA inspections and internal audits.
Automate Processes for Continuous Improvement
Relying on paper records or scattered digital files can lead to costly mistakes and inefficiencies. This is where automation becomes a game-changer. Implementing an Electronic Device History Record (eDHR) system helps reduce manual data entry errors and makes records much easier to manage and retrieve. Taking it a step further, integrating your eDHR into a comprehensive Quality Management System (QMS) is one of the most effective moves you can make. A good QMS software centralizes all your documentation, automates review and approval workflows, and provides a clear audit trail, ensuring everything stays compliant with minimal friction.
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Frequently Asked Questions
What’s the real difference between the DHR and the DMR? Think of it this way: the Device Master Record (DMR) is your master recipe book. It contains the complete, approved instructions for how to build your device. The Device History Record (DHR), on the other hand, is the journal you keep each time you follow that recipe for a specific batch or lot. It’s your proof that you actually followed all the steps in the DMR, used the right ingredients, and that the final product came out exactly as planned.
How long do we need to keep our Device History Records? According to FDA regulations, you must retain your DHRs for at least the expected life of the device, but no less than two years from the date the device is released for commercial distribution. It’s a good practice to confirm the specific requirements for your device class and the markets you sell in, as some regulations may require longer retention periods. The key is to ensure the record is available for as long as the device is in use.
Can our DHR be completely digital? Absolutely. Moving to an electronic DHR (eDHR) system is not only compliant but often a smarter way to manage your records. A digital system can significantly reduce the risk of human error, make your records easier to search and retrieve during an audit, and help ensure that nothing gets lost or misplaced. Just make sure your electronic system is secure and compliant with FDA 21 CFR Part 11 for electronic records and signatures.
What’s the most common mistake you see companies make with their DHRs? The most frequent issue is incompleteness. This often looks like missing signatures, blank fields on a quality check form, or a failure to document a deviation that occurred during production. These gaps create an incomplete story and are a major red flag for auditors. The best way to prevent this is to build checks and balances into your process so that a DHR cannot be closed out until every single required field is complete and verified.
Does every single medical device need its own DHR? Not necessarily for every individual unit, but every unit must be covered by one. The regulations require a DHR for each batch, lot, or unit. If you manufacture devices in large batches, you can maintain a single DHR that covers that entire production run. However, if you produce highly complex or custom devices one at a time, then each individual unit would require its own unique DHR.