DEVICE  DHF, DMR, DHR, and EU Technical Documentation / File

John E. Lincoln, Principal Consultant, J. E. Lincoln and Associates LLC

December 01, 2025

This is an update / expansion to a post on the same subject published April 27, 2016 (below).

Caveat.  There are many ways to meet the requirements of the Design History File (820.30), or the Design and Development File (ISO 13485, 7.3); the Device Master Record (DMR, the device “recipe”, 820.181); and the Device History Record (DHR, the device’s lot record, 820.184), required by the Device CGMPs as well as comparable documentation and Technical Documentation required by the EU and other countries other than the USA .  The following is one field tested approach, vetted over many years by various regulatory agencies and Notified Bodies (in inspections / audits, submissions, responses / remediations).

This brief discussion covers the general basic device documentation for regulatory, quality assurance and production requirements worldwide. Usually only the terminology changes.

In addition to starting a new DHF for a new device, a requirement, many  companies start a new DHF for major changes to their existing devices.  If minor changes they handle under the CGMPs (Change Control, 820.40(b)).  Moderate changes and similar could also be handled by an addendum to the existing DHF. Of course the DHF can be open for the life of the device (which I view as a change control nightmare); I recommend the DHF be closed at Design Transfer, when all final versions of documentation are approved and sent to their appropriate areas in the company, ready for device production.

As with most of the points discussed herein, there are more than one correct approach.

Generally I recommend to my clients if they ask, that the DHF be used for newly developed devices or major changes to an existing device (with each new major change an addendum to the original DHF, or a new, cross-referenced DHF), which require some type of control of a series of development changes per 820.30.  For a minor / simple change, I recommend change control under the CGMPs (820.40(b)), which at most companies is under a Change Request / Change Order (the CR when approved, can become the CO).  To it are attached the verification / test information / references, e.g., test report number / Lab Book Project number, etc., to justify the change, or in very simple changes, the actual data on the CR / CO.  The CO needs to have a block referencing a check doing the analysis (of the change itself, and of all the changes done since the last FDA submission) for the need to file a new 510(k) per two FDA Guidance Documents on changes to a device requiring a new 510(k) (replacing the old Memorandum K97-1), and also tied to some kind of list / log of changes for a cumulative change review as well per those same Guidances.  All this is filed in Document Control, usually under QA (as would a closed out DHF, in many companies).  Of course this requires that document changes be defined in such a way in an SOP to allow device changes (which are usually driven by a document change anyway, e.g., drawing change, specification change, etc.). 

When there is fielded software (firmware or software) and a revised version is created under change control, how does this affect the DMR and/or DHR?
Any change to a product, hardware or software, requires a change to the DMR (under change control, 820.40) for that product). Often the DMR includes a DHR template / blank (may be a "traveler" template /  blank, or in addition to a traveler), which would also be changed, or would at least drive a change to the DHR anyway, reflecting the new Revision / Release numbers of the software so changed (unless the Revision / Release Number entry is a fill-in blank). 

“Travelers” often address and document actual equipment settings (as opposed to ranges established by validation and outlined in SOPs, etc.), line clearance verification / sign-off, label count reconciliations, filled in BOMs (with lot numbers and quantity), inspection results and sign-offs by QC, non-conformance resolutions and approvals, deviations / completion / verification and approval, et al, and a final DHR / lot review and sign-off by QA.

Consider the situation where a company has updated software that is then sent out to their customers.  In such a case, one possibility is that both (DMR and DHR) are updated (the DMR drives DHR content), assuming that the software is changed across the board.  If you're changing software for one customer at a time, then you're furnishing custom software, each program unique to each customer, and your entire CGMP system would have to be designed under that system.  My discussion is focused on the assumption that the software is a revision / release, where all customers for that particular software get the same updates, new changes / revisions / releases. Of course, all changes (custom or generic) are done under change control.
  
To clarify the role of the DHF, DMR and DHR:  The DHF shows the development of the device proving that the eight* other requirements of 820.30 Design Control or of ISO 13485 7.3, Design and Development Planning, have been met in its development from the "start" date (usually when serious money is committed by the company to commercialize a previous R&D research project).  

The DMR is one result or design output from the DHF documented activities.  The DMR (820.81) is the device description, or "recipe": basically a list of all controlled records ("living documents") that define the device, to allow it's replication as defined in the FDA clearance (510(k)) or approval (PMA) documents.  The DMR might list device drawings, assembly work instructions / SOPs, test instructions / SOPs, BOM blanks (part numbers and part / component descriptions with blanks for quantity and lot numbers), blank travelers (which may list applicable validated / verified equipment settings with blanks to be filled in with the actual settings, operator or QC signatures and dates, and similar), reference other device specific SOPs, labels, Instructions for Use.  Some DMRs may list the generic SOPs that also apply to that device (and other devices), but don't have to. It would include the DHR template if additional to the above, e.g., traveler.

Additional on the DMR (the device "recipe"):  Although riskier, you could structure the DMR to list the device controlling documents without their current revision nos. / dates (e.g., list Drawing No. 0123, "current revision"; or SOP XYZ, "current revision” ).  Then the DMR would not always have to be updated when the device or software has minor changes, or even some major changes. However, the actual DHR template would have to be updated to reflect using the most current documents / settings / parts , et al, during manufacture of a lot.  All such changes would be under Change Control per 820.40.

The DHR (820.184) is the lot build history for one production lot; a record of how one lot / batch (lot number), or one serial number was built, quantities, RM lot numbers, dates, personnel involved where appropriate, proving that lot followed the "recipe" outlined in the DMR.  It would have the filled in / signed BOM, a filled / signed traveler (which could be a "DHR template blank"), samples of labels / IFUs included, sterile lot info (if sterilized), etc., showing / proving conformance to the DMR developed by the manufacturing process recorded in the DHF. Prior to release of that lot to the field, it would be reviewed and signed by QA, who would assure its accuracy and completeness of data and required enclosed documents.

In essence:   -- the DHF > DMR > DHRs.  See also "Definitions", 820.3. These terms will change with the new US QMSR (new 21 CFR 820, which includes ISO 13485 and ISO 9000, Clause 3, by reference) replacing the old US QSR (old 21 CFR 820).

Technical Documentation / Files:  This is a EU MDR term used to describe the documentation used to prove compliance to the EU MDR, especially the old MDD “Essential Requirements”, now referred to in the new MDR as the “General Safety and Performance Requirements”, and the rest of the MDR and any applicable standards or other regulatory requirements for that family of devices.  It’s closest comparison would be the US FDA’s 510(k), DeNovo, or PMA.  These are US FDA marketing authorizations, showing how the device meets its regulatory requirements in their respective countries and the vehicle to seek government regulatory clearance or approval for sale in those counties.  Both are reviewed by either the US FDA, or a Certified Notified Body (outside the US), prior to receiving permission to market in their respective countries.  The applicable manufacturing and quality / regulatory QMS is determined by the country(ies) where the device is to be marketed (no matter where manufactured).

The ultimate approach taken by a company must be defined by an SOP(s) and then followed!

*The 8 Design Control requirements (same for the CGMPs and ISO; I also use these as the subheadings in a DHF):

                1.  Design and Development Planning (e.g., a Gantt Chart);

                2.  Design Input;

                3.  Design Output;

                4.  Design Review;

                5.  Design Verification;

                6.  Design Validation;

                7.  Design Transfer;

                8.  Design Changes;

The remaining 2 elements of Design Control (total of 10):

                9.  Design Control SOP;

                10.  Design History File (DHF).

Note:  The above is available from JEL as a 90 minute (or longer) webinar for your company, or if a group desires it.  Inquire about availability and costs. Thanks. - John

- jel@jelincoln.com, 12/01/2025