Templates and records · ISO 13485 · Clause 7.5.1

Medical device batch history record

The birth certificate of each batch or unit: which materials, which equipment, by whom, with which controls and how many units left approved.

In one sentence

The batch history record identifies the batch or unit, the quantity manufactured and the quantity approved for distribution, the materials and components used, the equipment and processes, inspection results and the approved release, because ISO 13485 requires a verified and approved record for each device or batch allowing traceability (7.5.1 and 7.5.9) and the MDR requires each device to be associated with its UDI.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 13485 · Clause 7.5.1 Clauses are cited using the numbering of ISO 13485:2016, the current edition and the same one the Academy uses.
Type of information: Mandatory record Record per device or batch, verified and approved (7.5.1); traceability in 7.5.9
Who fills it in: Production, with quality release Final approval is signed by the person authorised to release product
When: While each batch is being made Closed at release; consulted for any complaint or recall
How long it is kept: Product lifetime, at least two years ISO 13485 requires records to be kept for at least the lifetime of the device as defined by the manufacturer, and never less than two years from release (4.2.5); the MDR requires technical documentation to be available for ten years after the last device was placed on the market, fifteen for implantables (Article 10(8)).

What the standard requires

What ISO 13485 demands and what it leaves to your judgement

For each device or batch, the standard requires a record that provides traceability to the extent specified in 7.5.9 and identifies the quantity manufactured and the quantity approved for distribution. That record is verified and approved before release.

The manufacturer defines the extent of traceability according to applicable regulations; for implantable devices the standard requires traceability of all components, materials and work environment conditions that could cause the device not to conform, and the consignee of each shipment to be recorded.

The European Regulation adds the UDI system (Article 27): the device identifier and the batch or serial number on the label, which must be linkable to this record.

Read it in context: Product realization, in the ISO 13485 Academy

Structure

Fields the template should include

Device, reference and batch or serial number
UDI-DI and UDI-PI
Manufacturing and expiry dates
Quantity manufactured and quantity approved for distribution
Batches of raw materials and components used
Equipment and parameters of the validated processes
Inspection and test results
Nonconformities in the batch and their handling
Labelling used and its version
Release: person, date and signature

Example

Example: batch of urinary catheters

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Batch	UF14-26-0412 · Uroflex catheter size 14 (fictitious)
Dates	Manufactured 12 April 2026 · expires April 2029
Quantities	10,000 manufactured · 9,940 approved · 60 destroyed at inspection
Materials	PVC batch M-2231 · packaging film batch E-0912
Processes	Extruder EX-01 · heat sealer TS-02 at 175 °C, 3 bar, 2 s · sterilisation cycle OE-26-114
Tests	Dimensional, leak-tightness and tensile conforming · sterilisation certificate received
Labelling	ET-UF-07, March 2026 version
Release	Quality technician · 28 April 2026

At the audit

Mistakes auditors commonly flag

Quantities manufactured, rejected and released do not reconcile.
The batch of a critical component is missing and traceability breaks.
Process parameters recorded outside the validated window with no follow-up.
Release signed before the sterilisation certificate has been received.
The UDI on the label cannot be linked to the batch record.

In Kimobox

How this record is kept in Kimobox

1Batch and UDI traceability is recorded from raw material to delivery.
2Nonconforming product from the batch is linked to it, with the decision taken and who took it.
3Critical suppliers are approved and re-evaluated from the supplier portal, according to the component's risk.

Frequently asked questions

What people ask us before getting started

Is the batch history record the same as the device file?

No. The device file describes how a type of device should be made and controlled; the batch record shows how a specific batch was actually made.

What is the UDI?

The unique device identification the MDR requires. It combines a device identifier (UDI-DI) and a production identifier (UDI-PI), which includes the batch or serial number, and is registered in the European Eudamed database.

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