A Device History Record (DHR) contains all the documents that are related to the manufacturing and tracking of a medical device. US Food and Drug Administration’s (US FDA) 21 CFR Part 820 mandates the manufacturers to maintain a DHR for each batch, unit, or lot. The DHR helps demonstrate that the medical device was manufactured according to the Device Master File (DMF). The critical components of the DHR allow the manufacturers and the auditors to effectively pinpoint significant device deviations. Also, with the help of a DHR, manufacturers can trace the root cause of any defects in the entire lifecycle of the medical device. In case the device manufacturing is outsourced to a contract manufacturer, the details of the person responsible for reviewing and releasing the device must be captured in the DHR and the contract.

In case the device is a Software as a Medical Device (SaMD) or has different variants or accessories, details of the same shall be clearly defined in the DHR. The retention period of the documents shall be as per the medical device’s lifecycle or at least for two (02) years. There is no such requirement stated for maintaining a DHR; it can be either as an electronic copy or hardcopy. However, necessary controls shall be clearly established.

Usage of a DHR

DHR is used to establish and maintain quality standards throughout the lifecycle of a medical device. As per 21 CFR 820, each batch or lot must meet the DHR requirements. The manufacturers can utilize the DHR to help in Corrective and Preventive Actions (CAPA) quality processes, improve product design, and streamline quality assurance.

Without proper documentation, it’s virtually impossible to find the root cause of the non-conformity and take the necessary Corrective and Preventive Actions (CAPA). When there is a product recall, manufacturers can trace the affected batch or lot, and can eliminate that batch instead of recalling all the products and also save a lot of money.

What are the Components of a Compliant DHR?

Manufacturers must submit a compliant DHR to the FDA to register a medical device. According to Section 820.184 of 21 CFR Part 820, the FDA requires medical device manufacturers to include the following components while submitting a DHR:

• Manufacturing date
• Manufacturing quantity
• Distribution date
• Testing documentation
• Labeling documentation
• UDI, UPC, or any other device identification and control number

What are the Benefits of a DHR?

The DHR can be of great benefit to the manufacturer. Manufacturers can easily refer to the DHR and hence solve all the issues. A DHR can be beneficial in:

• Complaints:

In case of a non-conformance or market complaint, identifying the potentially problematic batches and the root will ease through the UDI, UPC, or other device identifiers.

• Process improvement:

If a batch of products passes the manufacturer’s acknowledgment rules and is released into the market, but later some non-conformity is found, the ability to trace non-conformance to a specific batch can help the manufacturer understand the problem and re-design the acceptance criteria to prevent future occurrences of the defect.

• Limited liability and saves money:

The DHR permits manufacturers to exhibit that groups of the item were tried for acknowledgment with the DMR prior to being delivered for distribution. It likewise allows targeted reviews if only a certain batch is found to be defective. In case the manufacturer releases a batch of 1000 products for distribution and gets ten (10) non-conformance complaints about the same batch, then he can refer to the DHR and target the faulty batch and recall it.

Design History File (DHF) vs Device Master Record (DMR) vs. Device History Record (DHR)

DHF, DMR, and DHR may seem similar in name, but they are very different in purpose and are vital in the design control process. Let us have a look at how a DHR varies from the DHF and DMR.

Are you looking for assistance regarding a compliant DHR? Consult Freyr – a proven Regulatory expert. Stay informed. Stay compliant.