Design History File, DMR and DHR: Records and AI Licensing

What is a medical device design history file, and how do the DMR and DHR differ?

The design history file is the record of how a device was designed. The former FDA quality system regulation defined it as a file that "means a compilation of records which describes the design history of a finished device." The same rule defined the device master record as the procedures and specifications for a finished device, and the device history record as its production history (former 21 CFR 820.3). In short: the DHF explains why the device is the way it is, the DMR says how to build it, and the DHR proves each lot was built that way.

This page is general information, not legal or regulatory advice. Each rule below is quoted from FDA or the Code of Federal Regulations; your regulatory lead and counsel decide how it applies to your devices.

Thinking about what your design and test records could earn? Get an estimate for your records; for the engineering files alone, the CAD archive value calculator gives a quick range.

DHF, DMR and DHR under the 2026 QMSR: what changed

The names changed; the content mostly did not. FDA says "the revised part 820 is now titled the Quality Management System Regulation (QMSR), effective February 2, 2026," and that it incorporates ISO 13485:2016 by reference (FDA). ISO 13485 has no DHF, DMR or DHR, so in the final rule FDA said it is "not retaining separate requirements for these record types" (Federal Register).

FDA then mapped each one. "Consistent with the former DHF, Clause 7.3.10 requires the design and development file to contain or reference all the records necessary to establish compliance with design and development requirements." Specifications and procedures that "were included in a manufacturer's DMR and will now be located in the manufacturer's MDF." And "many of the requirements previously in the DHR are largely required to be in the medical device or batch record" (Federal Register).

Two practical points follow. Most quality teams still call the files DHF, DMR and DHR, and buyers understand both sets of names. And FDA says investigators may review QMS records "including those created before February 2, 2026" (FDA), so older design files remain live quality records, not an archive you can thin out.

How long must a device maker keep the DHF, DMR and DHR?

At least the lifetime of the device, and never less than two years from release. The current Part 820 relies on ISO 13485 clause 4.2.5 for record control (21 CFR 820.35). That clause reads: "The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization" (quoted in a Pathwise white paper; ISO sells the standard itself).

The licensing consequence is simple: a license hands over a copy and the originals never leave your quality system. Long-lived implants and capital equipment can keep their design files in retention for decades, which is also why those archives tend to be deep.

Can a medical device company license design and test records to AI developers?

Yes, for records the company owns and has cleaned. Part 820 governs how quality records are created, controlled and kept; it does not address sharing copies, so the limits come from ownership, contracts, privacy and export rules (21 CFR Part 820). FDA lets manufacturers mark records confidential (820.35(d)), which is a reminder that these files are trade secrets: share them only under a written license with use and confidentiality terms.

What makes a design file valuable to an AI developer is traceability. FDA describes the final design output in the design and development file as "the basis or starting point for the MDF" (Federal Register): requirements lead to drawings, drawings lead to tests, and tests lead to changes, all dated and approved. That chain of reasoning, written by engineers under audit, is rare outside regulated companies.

One buyer program publishes a figure: on 6 November 2026 Mercor listed $45K to $1.3M for hardware engineering companies of 20 to 2,000 employees, for CAD assemblies, circuit designs and test results (Mercor). That is a buyer program's published range, not a closed deal or a price for any one device file. For the CAD side in general, see licensing CAD and engineering data.

What stays out: patient data, complaints, supplier and customer files

Leave out anything that identifies a person or belongs to someone else. Complaint files are the clearest case: for complaints that are investigated, Part 820 requires the record to hold "the name, address, and phone number of the complainant" along with the details of the event (21 CFR 820.35(a)).

• Complaint, servicing and adverse-event files with names, contact details or health information. Use them only after full de-identification; see de-identifying company data.
• Clinical study data and case report forms. Their use is set by the consent forms and the clinical trial agreement, not by you alone.
• Supplier-owned designs: a contract manufacturer's process files, a component maker's drawings or a software vendor's code that sit in your DHF by reference.
• Anything under a customer quality agreement or a private-label supply contract. If you build to another company's design, the design is theirs; see contract manufacturer design data.
• Export-controlled technical data, if any device family has an export classification; run the ITAR and EAR checklist first.

How to prepare a design history file for an AI data license

Work from the quality system, not from shared drives, so every record keeps its approval status and revision.

• List devices and product generations, with the years each design file covers and the number of design changes.
• Export from the eQMS or PLM with links intact: requirement to output, output to test, test to change order.
• Tag each record by owner: your company, a supplier, a customer or a study sponsor. Remove all but your own.
• Strip names, serial numbers tied to patients and site identifiers from test and complaint-derived records.
• Record the export classification of each device family before anything leaves the building.
• Keep originals in place; the licensee gets a copy under a written agreement. If the company is closing, see the CAD archive in a hardware wind-down.
• Does your company hold records like these? See what your data is worth.
• Origin Data Partners works with companies that own data and helps get it bought. We are independent of the services on this page, and a buyer may pay us when a deal closes (how Origin is paid). See what your data is worth.