What it is
A device history record (DHR) documents the manufacture of a medical device unit or batch. An electronic device history record (EDHR) is the same record kept and assembled electronically. Quality standards and regulations for medical devices, such as ISO 13485, expect manufacturers to keep records that demonstrate that a device was made according to its requirements.
What it typically contains
The exact content depends on the product and the quality system, but typical elements include:
- What was manufactured, in what quantity and when
- Which specifications, drawing revisions and instructions applied
- Materials and components used, with their lot or batch identification
- Inspection and test results and the acceptance decision
- Labelling and identification information
Revision control is central
The value of the record depends on being able to say exactly which revision and instruction were in force. Released revisions should be immutable, with effective dates; a change should create a new revision. Each measurement and production record should reference the revision and instruction active when it was made.
From paper to data
Assembling a record from paper and spreadsheets is slow and error-prone. When production, measurement and quality data are connected, the record can be assembled from the source data, with provenance showing where each value came from.
Note
Regulatory requirements differ by market and product class. This article is general information, not regulatory or legal advice; check the requirements that apply to your products.
Standards and further reading
- ISO 13485 — Medical devices: quality management systems
- Regulatory authorities' quality management system requirements for medical devices (e.g. the FDA Quality Management System Regulation)