ISO 13485 · Medium · 12 min lesson

What a DMR is today - 21 CFR part 820 (QMSR), ISO 13485 clause 4.2.3 and the contents of the device file

21 CFR part 820 (QMSR, in force 2 February 2026) sections 820.7, 820.10, 820.35, 820.45; ISO 13485:2016 clauses 4.2.3, 4.2.5, 7.3.10, 7.5.1

What you will learn

Explain how the device master record concept maps to the medical device file of ISO 13485 clause 4.2.3 under the QMSR.
List the content of a DMR or device file: specifications, production process, quality assurance, packaging and labeling, installation and servicing.
Tell a DMR from the records that replaced the other legacy terms, and spot a device file that fails an auditor.

Key takeaways

The QMSR (21 CFR part 820, in force 2 February 2026) incorporates ISO 13485:2016 and no longer uses the terms DMR, DHF or DHR.
ISO 13485 clause 4.2.3 requires a medical device file for each device type or family; it holds or references what the DMR held.
Content: product specifications, manufacturing, packaging, storage, handling and distribution procedures, measuring and monitoring procedures, installation and servicing, labeling and instructions for use.
Design file is clause 7.3.10; the per batch record is clause 7.5.1 with clause 4.2.5; sections 820.35 and 820.45 add US specifics.
An auditor traces from the line to the file: the instruction in use must match the current released revision.

Free practice question

Brightwell's US quality manager hears that the DMR is gone since the QMSR took effect on 2 February 2026. A colleague proposes deleting the DMR index to save effort.

What is the right response?

Delete it, since part 820 no longer lists a DMR.

Not quite. Deleting removes the specifications that clause 4.2.3 and clause 7.5.1 still require for manufacture.

Keep it only for devices sold in the United States.

Not quite. Clause 4.2.3 applies to every device type the organisation makes, whatever the market where it is sold.

Replace it with the design history file.

Not quite. The design file in clause 7.3.10 does not hold manufacturing procedures and acceptance criteria.

Keep the content, maintained as the clause 4.2.3 medical device file, and rename the procedure if desired.

Correct. FDA removed the term while the elements remain required through clause 4.2.3 of the incorporated ISO 13485:2016.

Key terms

device master record: Former 21 CFR 820.181 term for the compilation of specifications and procedures for a finished device; replaced in concept by the medical device file.
medical device file: Records required by ISO 13485 clause 4.2.3 for each device type or family, containing or referencing the specifications and procedures for it.
QMSR: Quality Management System Regulation, the amended 21 CFR part 820 that incorporates ISO 13485:2016, in force from 2 February 2026.
design and development file: Clause 7.3.10 file with or referencing the records that show design and development requirements were met.
batch record: Clause 7.5.1 record that shows what was made, in what quantity and that it was approved for release.
incorporation by reference: Section 820.7 makes ISO 13485:2016 part of the regulation by naming it, so its clauses are enforceable requirements.
labeling inspection: Check required by section 820.45 that labeling is accurate and matches the medical device file before it is released.
controlled document: A document whose approval, revision and distribution are managed under clause 4.2.4 so only the current version is used.

Official sources

Go further

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

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Illustrative example. Educational only, not legal advice.