"Device Master Record" (DMR) and "Device History Record" (DHR) are FDA Quality System Regulation terms, not MDR terms. The MDR does not use either phrase in Regulation (EU) 2017/745. The equivalent obligations under the MDR live in Article 10(8) (technical documentation retention), Article 25 (identification and traceability within the supply chain), and the quality management system under Article 10(9). Operationally, the FDA's DMR maps to the medical device file required by clause 4.2.3 of EN ISO 13485:2016+A11:2021. The file that specifies how the device is made. The FDA's DHR maps to the production and service provision records required by clause 7.5 of the same standard. The records that prove a specific unit or batch was made that way. Together, the medical device file and the production records give you the same forward-and-backward traceability a DMR/DHR pair gives under FDA, without the FDA labels.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • Device Master Record (DMR) and Device History Record (DHR) are terms from the US FDA Quality System Regulation at 21 CFR 820.181 and 21 CFR 820.184. The MDR does not use either term.
  • Under Regulation (EU) 2017/745, the closest legal anchors are Article 10(8) on technical documentation retention and Article 25 on identification and traceability within the supply chain.
  • The DMR equivalent under EN ISO 13485:2016+A11:2021 is the medical device file required by clause 4.2.3. A file per device or device family specifying how the device is designed, produced, installed, and serviced.
  • The DHR equivalent under EN ISO 13485:2016+A11:2021 is the set of production and service provision records required by clause 7.5. The records of what actually happened when each unit or batch was made, inspected, and released.
  • Together, clause 4.2.3 (the "recipe") and clause 7.5 (the "cooking log") give forward traceability from unit back to specification and backward traceability from field complaint to batch, satisfying MDR Article 25 supply-chain traceability and feeding the technical documentation retention obligation under Article 10(8).

Why the labels matter less than the records

A startup in eastern Austria was shipping its first Class IIa devices when a distributor reported that a handful of units in one shipment had a labelling defect. The lot code on the carton did not match the code printed on the device. The team had three hours before the distributor needed a decision on whether to accept the shipment or return it. Forty minutes later the quality lead had pulled the medical device file for that device, confirmed the correct labelling specification, opened the production record for the relevant batch, identified which work order had produced the misprinted cartons, traced the error to a specific operator shift and a label printer that had been reset during the run, and confirmed from the final inspection record that the devices themselves were conforming. The distributor kept the shipment. A targeted rework was scheduled for the affected cartons. The CAPA ran for two weeks and closed the printer handling procedure gap. None of this worked because the team had a "DMR" or a "DHR" by name. It worked because clause 4.2.3 of EN ISO 13485:2016+A11:2021 had given them the recipe and clause 7.5 of the same standard had given them the cooking log, and the two were linked by lot number.

A different startup, mid-size, had no equivalent structure. They had folders. They had spreadsheets. They had the design and development file (from clause 7.3) but the production side was informal. The assumption was that the CMO was handling it. When a field issue came in, they could not reconstruct which batch the complaint unit came from, which work order produced the batch, or which supplier lot of a critical component was used. The investigation ran for six weeks and ended with an assumption, not a finding. The Notified Body's next audit opened on that point.

The label "DMR" or "DHR" is irrelevant to both stories. The presence. Or absence. Of a medical device file under clause 4.2.3 and production records under clause 7.5 is what made the difference. Labels follow regulation. Structure follows records.

Where DMR and DHR come from. And why they are not MDR terms

"Device Master Record" is defined in the US FDA Quality System Regulation at 21 CFR 820.181 as a compilation of records containing the procedures and specifications for a finished device. "Device History Record" is defined at 21 CFR 820.184 as a compilation of records containing the production history of a finished device. Both are operational terms specific to the FDA QSR framework. They are useful, specific, and well understood by anyone who has worked in US MedTech.

The MDR does not use either term. Nowhere in Regulation (EU) 2017/745. Not in the articles, not in the annexes. Will you find "Device Master Record" or "Device History Record". That is not an oversight. The MDR relies on a different regulatory architecture. Instead of prescribing a named DMR and DHR, the MDR does three things: it requires a QMS under Article 10(9), it requires identification and supply-chain traceability under Article 25, and it requires manufacturers to keep their technical documentation and QMS records available for the regulator for defined periods under Article 10(8). The content that a US manufacturer would put into a DMR and a DHR has to exist somewhere in the MDR system. But the name and exact structuring are not legally mandated. They are mandated by the harmonised standard the manufacturer uses to give presumption of conformity with the QMS obligation, and that standard is EN ISO 13485:2016+A11:2021.

The practical consequence is that a European manufacturer who uses the labels "DMR" and "DHR" is using FDA shorthand. The legal obligation is elsewhere. A manufacturer certified to EN ISO 13485:2016+A11:2021 already has the structural equivalents built in. They just have different names in the standard.

The ISO 13485 mapping: clause 4.2.3 and clause 7.5

EN ISO 13485:2016+A11:2021 locates the DMR and DHR equivalents in two different clauses, reflecting the fact that they do different jobs.

Clause 4.2.3. The medical device file (the DMR equivalent)

Clause 4.2.3 of EN ISO 13485:2016+A11:2021 requires the organisation to establish and maintain one or more files, either containing or referencing documents generated to demonstrate conformity to the requirements of the standard and compliance with applicable regulatory requirements. For each medical device type or medical device family, the file has to include or reference documents covering a general description of the device, intended use, and labelling (including any instructions for use); specifications for the product; specifications or procedures for manufacturing, packaging, storage, handling, and distribution; procedures for measuring and monitoring; and, as appropriate, requirements for installation and for servicing.

That list is effectively the FDA's DMR content written in ISO dialect. It is the "how to make and support this device" file. It specifies the device. It is not the record of any individual unit. It is the reference against which any unit must conform. In an MDR context, clause 4.2.3 is also closely coupled to the technical documentation under Annex II. Much of the medical device file content overlaps with Annex II sections 1 (device description and specification), 2 (labelling and IFU), and 3 (design and manufacturing information). A competent QMS treats the medical device file and the Annex II technical documentation as two views of the same underlying specification set, not as two parallel files that drift apart.

Clause 7.5. Production and service provision records (the DHR equivalent)

Clause 7.5 of EN ISO 13485:2016+A11:2021 covers production and service provision. Its sub-clauses require the organisation to plan, carry out, monitor, and control production and service provision activities in accordance with planned arrangements, and to maintain records that provide evidence that the product meets specified requirements. For each medical device or batch, these records cover the amount manufactured, the amount approved for distribution, and traceability. Where applicable, clause 7.5 includes sub-clauses on cleanliness of product, installation activities, servicing activities, particular requirements for sterile medical devices (process validation records), identification, traceability, and preservation of product.

Clause 7.5.9 specifically addresses traceability and requires procedures that enable the organisation to identify the extent of traceability required by the regulatory requirements. Meaning, under the MDR, the traceability obligation of Article 25 flows through here. For implantable devices, clause 7.5.9.2 adds requirements to trace components, materials, and the conditions of the work environment as part of the device records.

Taken together, clause 7.5 produces the record set that would, under FDA terminology, populate a DHR: batch records, work orders, in-process inspection records, release records, identification and traceability records, and (where relevant) sterilisation or installation records. These are the "what actually happened on this batch" records, the cooking log to clause 4.2.3's recipe.

A worked traceability example

Consider a Class IIa device manufactured in lots of 200 units by a contract manufacturer, with critical components sourced from two suppliers. A field complaint arrives: a single device, unit serial number 47-00983, is exhibiting a specific failure mode.

Backward traceability, under EN ISO 13485:2016+A11:2021 clauses 7.5 and 7.5.9 and MDR Article 25: - Serial 47-00983 belongs to lot 47, produced on a specific date on a specific line. - Lot 47 production record identifies which work order was executed, by which operators, against which revision of the manufacturing specification in the medical device file (clause 4.2.3). - The incoming inspection records for lot 47 identify which supplier lots of each critical component were consumed. - The final inspection and release record for lot 47 shows the acceptance criteria applied and the results. - The distribution record shows every distributor and end customer that received a unit from lot 47, enabling a targeted field safety action if required.

Forward traceability, in the other direction: - The medical device file (clause 4.2.3) identifies the current and superseded specifications for the device. - The change control record (clause 7.5 combined with clause 7.3.9) shows when specifications changed and which lot was the first to be produced under the new version. - This allows the team to confirm whether the failure mode correlates with a specification change, a supplier change, a process parameter drift, or a genuinely random unit-level defect.

That full loop. Recipe, cooking log, and linkage between them via lot and serial. Is what MDR Article 25 requires in substance, what clause 4.2.3 and clause 7.5 operationalise in structure, and what a US team would casually describe as "DMR and DHR". The label does not matter. The closed loop does.

A startup records playbook

For a small team building this from scratch under MDR:

  1. Create one medical device file per device or device family under clause 4.2.3. This is a list of documents. Not necessarily a single physical binder. Each item is controlled under clause 4.2.4 document control. The file references, or contains, every specification needed to make and support the device: the device description, labelling and IFU, product specifications, manufacturing and packaging specifications, storage, handling, distribution, measuring and monitoring procedures, and installation and servicing where applicable.

  2. Map each item in the medical device file to the corresponding section of the MDR Annex II technical documentation. A clean map prevents the medical device file and the Annex II file from drifting apart. A good rule: the medical device file IS the master specification layer; the Annex II file is the formal regulatory presentation of the same content.

  3. Establish production and service provision records under clause 7.5 from the first production run, not the tenth. Each batch or lot has a production record containing: the work order referenced, the specification revisions applied, the operator and line used, the supplier lots of critical components, in-process inspection results, final inspection results, release decision, and the distribution destinations.

  4. Implement a lot numbering and serial numbering scheme from day one. This is the connective tissue of Article 25 traceability. Every unit has to be identifiable back to its lot; every lot has to be identifiable forward to its distribution. See post 300 in this cluster on lot numbering and traceability for the scheme design.

  5. Retain the records for the periods required by Article 10(8) of Regulation (EU) 2017/745. At least 10 years after the last device has been placed on the market, and at least 15 years for implantable devices. The retention policy sits in the document control procedure and applies to both the medical device file and the production records.

  6. Run one internal traceability drill per quarter: pick a random serial in the distribution record and reconstruct backward to the incoming components, and pick a random component supplier lot and reconstruct forward to every device that consumed it. If the drill takes more than an hour, the record structure needs work before the next audit.

Reality Check. Where do you stand?

  1. If I hand you a serial number from a device sold 14 months ago, can you produce the production record for its lot, the incoming inspection records for its components, and the final release record within one working hour?
  2. Does your medical device file under clause 4.2.3 exist as a controlled list, or is it a folder of documents people assume is complete?
  3. Does your medical device file map cleanly onto the MDR Annex II sections it feeds, or are the two files maintained in parallel and drifting apart?
  4. Are production records under clause 7.5 generated and retained for every batch, or only "for the important ones"?
  5. For implantable devices (if applicable), do your records include component-level and material-level traceability as required by clause 7.5.9.2?
  6. Does your record retention policy enforce the Article 10(8) periods. At least 10 years for non-implantable and at least 15 years for implantable devices?
  7. When you use the labels "DMR" or "DHR" internally, does the team understand those are FDA terms and the governing obligations in Europe are MDR Article 10(8), Article 25, and clauses 4.2.3 and 7.5 of EN ISO 13485:2016+A11:2021?
  8. If a Notified Body auditor picked a random lot from last quarter tomorrow morning, could your current records answer every traceability question on that lot by end of day?

Any answer that is not a confident yes is a work item before the next audit window.

Frequently Asked Questions

Does the MDR require a Device Master Record or a Device History Record? Not under those names. Regulation (EU) 2017/745 does not use the terms "Device Master Record" or "Device History Record" anywhere in its text. The legal obligations are in Article 10(8) on technical documentation retention, Article 25 on identification and traceability, and Article 10(9) on the QMS. The structural equivalents of the FDA DMR and DHR are the medical device file required by clause 4.2.3 and the production records required by clause 7.5 of EN ISO 13485:2016+A11:2021.

What is the difference between a medical device file and the technical documentation under Annex II? They overlap heavily but are not identical. The medical device file under clause 4.2.3 is the QMS-level specification master: description, labelling, product and process specifications, monitoring, and service requirements. The technical documentation under Annex II is the formal regulatory file presented to the Notified Body and the regulator, with its own mandatory structure. A good QMS treats the medical device file as the master specification and Annex II as the regulatory view of that same specification, controlled under one document system so they cannot drift.

How long do I have to retain production records under MDR? Article 10(8) of Regulation (EU) 2017/745 requires manufacturers to keep the technical documentation, the EU declaration of conformity, and the certificates issued by Notified Bodies available to the competent authorities for at least 10 years after the last device covered has been placed on the market, and at least 15 years for implantable devices. Production records generated under clause 7.5 are part of the QMS records that underpin that technical documentation and are retained under the same retention policy.

Does clause 4.2.3 require a separate file per individual device, or per device family? Clause 4.2.3 of EN ISO 13485:2016+A11:2021 allows a file per medical device type or per medical device family. A family file is acceptable when the devices share the relevant specifications, but the file has to be clear about which specification applies to which variant. Where variants diverge significantly in manufacturing or performance, separate files are cleaner and less error-prone.

If our contract manufacturer keeps the production records, are we still compliant? The legal manufacturer placing the device on the EU market is responsible under MDR Article 10 for the QMS and the technical documentation. A contract manufacturer may physically hold some production records, but the manufacturer must have contractual access, must be able to retrieve records on demand (including for Notified Body audits and competent authority requests), and must retain the records for the Article 10(8) periods. The legal obligation does not transfer with the physical location of the files.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10(8) (technical documentation retention), Article 10(9) (quality management system), and Article 25 (identification and traceability within the supply chain). Official Journal L 117, 5.5.2017.
  2. EN ISO 13485:2016 + A11:2021. Medical devices. Quality management systems. Requirements for regulatory purposes, clause 4.2.3 (medical device file), clause 4.2.4 (control of documents), clause 7.5 (production and service provision), including sub-clause 7.5.9 on identification and traceability and sub-clause 7.5.9.2 on particular requirements for implantable medical devices.
  3. US Code of Federal Regulations, Title 21, Part 820.181 (Device Master Record) and Part 820.184 (Device History Record). Cited for terminology origin only. The FDA QSR is not the governing law for devices placed on the EU market under MDR.

This post is part of the Quality Management Under MDR cluster in the Subtract to Ship: MDR blog, linking up to the QMS pillar at post 276. Authored by Tibor Zechmeister and Felix Lenhard. "DMR" and "DHR" are FDA shorthand. In Europe, the legal basis is MDR Article 10(8), Article 25, and Article 10(9), and the structure that satisfies them is clauses 4.2.3 and 7.5 of EN ISO 13485:2016+A11:2021.