The Device History Record (DHR) is a specific set of documentation requested by the FDA Quality System Regulation; however nowadays it is something that is typically requested by any type of regulation.
We have already been discussing about specific documentation that is requested by FDA regulation like Device Master Record (DMR) and Design History File (DHF); the DMR can be considered equivalent to the so-called Medical Device File specifically requested by ISO 13485.
The definition of DHR is provided in section 820.3(i) of FDA QSR 21 CFR 820:
Device history record (DHR ) means a compilation of records containing the production history of a finished device.
In this article we will go more in details on how the device history record is prepared and what shall be included there in based on the applicable regulatory requirements.
What shall be included in the Device History Record (DHR)?
The specific contents of the Device History Record are reported within 21 CFR 820.184. Specifically, the DHR shall include:
(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.
In other words, the DHR contains the production history of specific devices or batches of device; this includes as well the final tests on the specific device and the activity related to the release of the product on the market.
DHR and Quality Management System
The device history record is a fundamental set of documentation that can be used within several processes of the quality management system of a company.
First, it has a big impact on traceability since ti provides a full insight into the whole production journey of the device.
The Device History Record is typically needed to be review in case of deviations highlighted on the product on the market, thus in a context of technical investigations. It is in fact often necessary to review the DHR and see if there were any anomalies highlighted in the production documentation.
The Device History Record is also essential for the release of the product on the market; actually the release of the product is documented within the DHR.
It is very important to highlight that the purpose of the DHR release process is to provide evidence that the product was produced according to predefined and validated specifications.
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