QMSR Vocabulary: Old 820 Terms vs ISO 13485 and EU MDR
The QMSR retired DHF, DMR, DHR and "management with executive responsibility." A crosswalk to ISO 13485 and EU MDR, and why the label matters less than the content.
MLR Associates | Quality systems
The QMSR took effect on February 2, 2026.
Part 820 now incorporates ISO 13485:2016 by reference, and most of the old Quality System Regulation text is gone.
Most of its vocabulary went with it.
DHF, DMR, DHR and "management with executive responsibility" no longer appear in the regulation.
Teams are now renaming their SOPs and templates to match.
Some of that is worth doing.
Most of it does not change what an inspector looks for.
The Word Is a Label. The Content Is What Counts.
An inspector does not clear a file because the folder says Design and Development File instead of Design History File.
They follow the evidence of the work:
- A design plan
- Design inputs that are written and testable
- Outputs that trace to those inputs
- Objective evidence for verification and validation
- A controlled transfer to manufacturing
- Design changes with reviews and approvals
A DHF that shows all of that passes under any name.
A relabeled file that cannot show it fails.
Renaming has a real cost when it becomes the project.
Teams spend months reissuing documents to swap terms.
Meanwhile the gaps that draw findings stay put: missing traceability, and risk controls that never became requirements.
Fix the content first.
Update the labels at the next normal revision of each document.
Put a one-page crosswalk in the Quality Manual so anyone can map an old term to its new one.
Auditors use it. So do new hires.
A few terms did change meaning.
Top management is a narrower group than management with executive responsibility.
The Medical Device File covers more than the old DMR.
Management review, internal audit and supplier audit reports are no longer protected from FDA inspection the way they were under the old 820.180(c).
Where the substance changed, update the procedure along with the label.
Everywhere else, the rename is housekeeping.
Vocabulary Crosswalk: Old 820 vs ISO 13485 and EU MDR
Legacy terms come from 21 CFR Part 820 as it stood before February 2, 2026.
ISO 13485:2016 supplies the new terms, since the QMSR incorporates it by reference.
The EU MDR column shows where the same content sits in Regulation (EU) 2017/745.
N/A means the MDR has no single named equivalent, and the requirement sits inside the manufacturer's quality management system under Article 10(9).
| Old 820 term (QSR) | Old section | ISO 13485:2016 term | Clause | EU MDR 2017/745 |
|---|---|---|---|---|
| Quality System Regulation / quality system | Part 820 / 820.5 | Quality management system | 4.1 | Quality management system, Art. 10(9) |
| Quality system record | 820.186 | Quality manual / QMS documentation | 4.2.1, 4.2.2 | N/A |
| Management with executive responsibility | 820.3(n), 820.20 | Top management | 5.1 (ISO 9000 3.1.1) | N/A |
| Quality policy | 820.20(a) | Quality policy | 5.3 | N/A |
| Quality plan | 820.20(d) | Quality planning / planning of product realization | 5.4.2, 7.1 | N/A |
| Management representative | 820.20(b)(3) | Management representative | 5.5.2 | Person responsible for regulatory compliance, Art. 15. A different role, often confused with it |
| Management review | 820.20(c) | Management review | 5.6 | N/A |
| Personnel / training | 820.25 | Human resources / competence, training and awareness | 6.2 | N/A |
| Quality audit | 820.22 | Internal audit | 8.2.4 | N/A |
| Design and development planning | 820.30(b) | Design and development planning | 7.3.2 | N/A |
| Design input | 820.30(c) | Design and development inputs | 7.3.3 | General Safety and Performance Requirements, Annex I |
| Design output | 820.30(d) | Design and development outputs | 7.3.4 | Design and manufacturing information, Annex II §3 |
| Design review | 820.30(e) | Design and development review | 7.3.5 | N/A |
| Design verification | 820.30(f) | Design and development verification | 7.3.6 | Product verification and validation, Annex II §6 |
| Design validation | 820.30(g) | Design and development validation | 7.3.7 | Annex II §6 / clinical evaluation, Art. 61 and Annex XIV |
| Design transfer | 820.30(h) | Design and development transfer | 7.3.8 | N/A |
| Design changes | 820.30(i) | Control of design and development changes | 7.3.9 | N/A |
| Design History File, DHF | 820.30(j) | Design and development file | 7.3.10 | Technical documentation, Annex II |
| Device Master Record, DMR | 820.181 | Medical device file | 4.2.3 | Technical documentation, Annexes II and III |
| Device History Record, DHR | 820.184 | Record for each medical device or batch | 7.5.1 | N/A |
| Document controls | 820.40 | Control of documents | 4.2.4 | N/A |
| Records, general requirements | 820.180 | Control of records | 4.2.5, plus retained 820.35 | N/A |
| Purchasing controls | 820.50 | Purchasing / evaluation of suppliers | 7.4 | Suppliers and subcontractors, Annex II §3 |
| Identification / traceability | 820.60, 820.65 | Identification / traceability / implantable devices | 7.5.8, 7.5.9 | Unique Device Identification, Art. 27 |
| Production and process controls | 820.70 | Control of production and service provision | 7.5.1 | N/A |
| Inspection, measuring and test equipment | 820.72 | Control of monitoring and measuring equipment | 7.6 | N/A |
| Process validation | 820.75 | Validation of processes for production and service provision | 7.5.6, 7.5.7 | N/A |
| Acceptance activities / acceptance status | 820.80, 820.86 | Monitoring and measurement of product | 8.2.6 | N/A |
| Nonconforming product | 820.90 | Control of nonconforming product | 8.3 | N/A |
| Corrective and preventive action, CAPA | 820.100 | Corrective action / preventive action | 8.5.2, 8.5.3 | N/A |
| Labeling and packaging control | 820.120, 820.130 | Control of production and service provision / preservation | 7.5.1, 7.5.11, plus retained 820.45 | Information supplied by the manufacturer, Annex I Ch. III and Annex II §2 |
| Handling / storage / distribution | 820.140 to 820.160 | Preservation of product | 7.5.11 | N/A |
| Installation | 820.170 | Installation activities | 7.5.3 | N/A |
| Complaint files | 820.198 | Complaint handling / reporting to regulatory authorities | 8.2.2, 8.2.3, plus retained 820.35 | Post-market surveillance, Art. 83 and Annex III / vigilance, Art. 87 |
| Servicing | 820.200 | Servicing activities | 7.5.4 | N/A |
| Statistical techniques | 820.250 | Analysis of data | 8.1, 8.4 | N/A |
What the FDA Kept
Part 820 still carries a few US requirements that an ISO 13485 certificate does not cover.
- 820.3 definitions: Component, finished device, remanufacturer and batch or lot are retained. FD&C Act definitions such as device and labeling override the ISO versions. The old definitions of customer, design validation, nonconformity, process validation and verification were removed in favor of the ISO 13485 and ISO 9000 vocabulary.
- 820.35 Control of records: Complaint and servicing records need specific content beyond ISO 13485 Clause 4.2.5. The UDI must be recorded for each device or batch. Records sent to FDA can be marked confidential.
- 820.45 Device labeling and packaging controls: Labeling is inspected for accuracy, and its release is documented before use, in addition to Clause 7.5.1. Packaging operations must prevent mix-ups.
The Bottom Line
Build the crosswalk once and publish it in the Quality Manual.
Then spend the effort where an inspector or notified body reviewer will look: traceability from user need to evidence, and a risk file tied to the design.
Call the file whatever you like.
Make sure it holds up.
References
- Quality Management System Regulation, 21 CFR Part 820. Final rule, 89 FR 7496, Feb. 2, 2024. Effective Feb. 2, 2026.
- Quality System Regulation, 21 CFR Part 820, 1996 edition, superseded Feb. 2, 2026.
- ISO 13485:2016. Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes.
- ISO 9000:2015. Quality Management Systems, Fundamentals and Vocabulary, Clause 3.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices. Official Journal of the European Union, 2017.
Questions or feedback: mike@mlreoconsulting.com