ISO 13485 · Medium · 12 min lesson

Building and controlling the device file - structure, index, change control, approvals and links to the design file and technical documentation

ISO 13485:2016 clauses 4.2.3, 4.2.4, 7.3.8, 7.3.9, 7.3.10; 21 CFR part 820 sections 820.10 and 820.35; Regulation (EU) 2017/745 Annex II

What you will learn

Structure a device file by type or family and keep an index that shows revision, status and owner of every item.
Run revision and change control: engineering change order, impact assessment, approval before implementation and effective dating.
Link the device file to the design and development file and to EU technical documentation without contradictions.

Build one device file per type or family, with an index showing identifier, revision, status, owner and location of each item.
Clause 4.2.4 requires approval before issue, review and update, identification of changes, current versions at points of use and prevention of obsolete use.
Clause 7.3.9 requires design changes to be identified, reviewed, verified, validated as appropriate and approved before implementation.
An engineering change order assesses risk, verification, regulatory impact, labeling, suppliers, stock and work in process before release.
Design file (clause 7.3.10), device file (clause 4.2.3) and EU technical documentation (MDR Annex II) must agree on revisions.

Brightwell finds that engineers keep drawings on laptops, and the product data system and the floor show different revisions of DRW-1007.

What is the first corrective step for the file?

Ask engineers to email their versions to the supervisor.

Not quite. Emailing copies of drawings spreads further uncontrolled versions and contradicts the document control required by clause 4.2.4.

Delete the product data system copy.

Not quite. Removing the controlled source destroys the master referenced by the clause 4.2.3 file.

Wait until the next management review.

Not quite. Delay leaves obsolete documents in use, which clause 4.2.4 does not allow.

Make the controlled index the single source and replace floor copies with the released revision.

Correct. Clause 4.2.4 requires current versions at points of use and prevention of obsolete use.

engineering change order: A controlled record that proposes, assesses, approves and implements a change to a released document or design.
impact assessment: Structured review of what a change affects: risk, verification, regulatory status, labeling, suppliers and stock.
effective date: The date or point (such as a lot or serial number) from which a new revision must be used and the old one withdrawn.
revision status: The identified current version of a document, which clause 4.2.4 requires to be determinable.
design transfer: Clause 7.3.8 activity that makes sure design outputs are verified as suitable for manufacturing before they become final specifications.
point of use: The place where work is done, such as a station, where clause 4.2.4 expects relevant document versions to be available.
technical documentation: EU documentation described in MDR Annex II that shows conformity of the device; it must agree with the device file.
device family: A group of devices sharing design and manufacturing so that one file under clause 4.2.3 can cover them with justification.

The full lesson has narrated slides, more scenario questions with explained answers and a simulation.

Illustrative example. Educational only, not legal advice.