ISO 13485 · Medium · 12 min lesson
What a device history record is and what it must show - clauses 7.5.1, 7.5.8 and 7.5.9
ISO 13485:2016 clauses 7.5.1, 7.5.8, 7.5.9 and 8.2.6; 21 CFR 820.10, 820.35(c) and 820.45 (QMSR); former 21 CFR 820.184
What you will learn
- Explain what a device history record is, and which clauses of ISO 13485 and the QMSR require the record for each device or batch.
- List the content a DHR must show: dates, quantities manufactured and released, acceptance records, primary label and labeling, UDI and control numbers.
- Link the DHR to traceability under clause 7.5.9, tell a weak record from a compliant one and say what an auditor asks.
Key takeaways
- A DHR shows what was actually made, per device or batch; clause 7.5.1 requires it to be verified and approved and to show amounts manufactured and approved.
- The classic content: dates, quantity manufactured and released, acceptance records, primary label and labeling, device identification and control numbers.
- Clause 8.2.6 requires evidence of conformity with acceptance criteria and identification of the person authorising release.
- The QMSR (section 820.35(c)) requires the UDI recorded for each device or batch; section 820.45 controls labeling.
- Clause 7.5.9 sets the extent of traceability; a DHR index makes every referenced document retrievable.
Free practice question
A hospital asks Corvane how many sets of lot 2417 were made and released. The DHR says "about 5000" and the shipping system shows 4,950 sets sent.
What does clause 7.5.1 require the record to show?
The amount manufactured and the amount approved for distribution, as exact reconciled numbers.
Correct. Clause 7.5.1 requires the record to identify the amount manufactured and the amount approved for distribution.
Only the approximate size of the batch.
Not quite. An approximation cannot be reconciled with shipments, so it fails the identification of amounts in clause 7.5.1.
Only the number of customers served.
Not quite. Customer data is a distribution record under clause 7.5.9, not the amounts required by clause 7.5.1.
Nothing, since shipping records are enough.
Not quite. Clause 7.5.1 requires a manufacturing record for each batch, independent of the shipping system.
Key terms
- device history record: The record of what was actually made for each device or batch, showing traceability, amounts manufactured and approved (clause 7.5.1).
- medical device file: The file of specifications and procedures for a device type (clause 4.2.3); it replaces the former device master record.
- UDI: Unique device identifier with a device identifier and a production identifier such as lot, serial or expiry (clause 7.5.8).
- traceability: The ability to follow a device back to its materials and forward to its consignees (clause 7.5.9).
- QMSR: The FDA regulation that replaced the quality system regulation and incorporates ISO 13485 by reference (21 CFR part 820).
- reconciliation: Showing that started quantity equals passed, rejected, sampled and retained units, with differences explained.
- acceptance records: Results of checks against criteria, with instrument, person and date (clause 8.2.6).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- 21 CFR 820.10 and 820.7, Quality Management System Regulation requirements and incorporation of ISO 13485 (eCFR)
- 21 CFR 820.35, Control of records (eCFR)
- 21 CFR 820.45, Device labeling and packaging controls (eCFR)
- 21 CFR 820.184, Device history record (former text, Cornell LII)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.