The Device Master Record should list all of the documents and procedures used to make the

product.

The Device History Record is usually a folder that contains (at least in our medical device plant):

* either a copy of the documents the product was made to or a traveler that lists the documents,
revisions, and dates of manufacture.

* quality assurance documentation, such as label reports with an actual label on the report

* a form filled out by QA as final inspection of product, and one for final inspection of folder

* BOM product was made to, etc.

The list is not all-inclusive, but you get the idea. Documents in the DHR map back to the
requirements of the DMR. Does that help?
Last edited: Mar 23, 2005


Re: Wanted: Device History Record (DHR) Templates

Al Rosen said:
That covers it.
Hi Al,
I was wondering if you had an DHR procedure template I can use. I understand what required to
go into the DHR and I understand about all of the forms used on the manufacturing floor for a
finish device product, but the actually procedural process written into a SOP or DHR procedure.
Are you able to help me. I am writing a DHR procedure for a medical device company. Deidra
Thanks for the reply Al.
But isn't there a standard list of things one must include...generalities?
Our company is based in Canada, and up here, in its guidance documentation, Health
Canada lists the following:

proof/records that all operations, processes described in the DMR have been accomplished
dates of manufacturing
quantity manufactured
quantity released for distribution
device ID and control # used
labeling used for each production unit
acceptance records demonstrating that the device was manufactured in accordance with the
DMR.
 1.) DMR.... like an index showing where specific files are?
2.) DHF.... a file containing all the pertinent information about how you got to
the point of producing the product?
3.) DHR.... individual records of each manufactured product or group of
products (batch)?
4.) Master Batch Record.... Same as a DHF?
5.) Batch Record.... Same as a DHR?

ake a breath, Ted, it will be ok, I promise!

1) DMR - Device Master Record. This can be a matrix or index that identifies the pertinent
documents/procedures/records/specs, etc. and their location.
2) DHF - Design History File. This is all the documentation that results from the design
history - all the activities of the design team (planning, input, review, output, review,
changes, transfer, etc.). This should all be included in the DHF.
3) DHR - Device History Records. These are all the records generated during the production,
testing, review, inspection, etc. of the device(s). These can include production schedules,
specs, inspection reports/records, NCRs, CARs, MRBs, deviations, etc. - anything relevant to
the production of that lot/batch of device(s).
4) Master Batch Record. This is not a term we (current company) use, but it could be similar
to the DHF or DMR. I'm not certain.
5) Batch Record. This is what I would consider to be the same as the DHR.

DHF - Design History File, this is the documents that were compiled during the design of
the product, Customer requirements, System requirements, User Requruirements,
prototyping, design reviews, risk analysis, verification etc etc
This document is for the design of a device and the inspectors use it to verify that input
(requirements) match output (design effort). Updates to this are required if you amend the
design of the device (and features, change specs etc)

DMR - Device Master Record, this is a compilation or listing of all the materials, drawings,
labels, BOM's, SOP's, WI's that are needed to manufacture the device (think of a recipe card,
a listing of all that is required to bake a cake)

DHR - Device History Record, this is a compilation of the records, charts, routing cards, etc
etc that were used to during the manufacture of the device (if you had to complete a record
for every stage of baking the cake, packing and shipping the cake, this would be your DHR)

Batch Record, this is a document that records what happened during a particular part of the
process (you would have lots of these when baking your cake, oven prep, oven temp, lot
number of flour used, name of hen who layed eggs you used...he he, guess you get the
idea). These records are refenced in the DMR, completed ones are part of the DHR.

Master Batch Record, probably refers (I say prob cause not a term I am familiar with) to the
controlled copy of a batch record held in an area that copies are made from for use when
you manufacture, when there is an update to the batch record in question the current
master becomes superseded and is replaced with this new master. These days master
records are mostly held electronically and printed when required.
TITLE 21–FOOD AND DRUGS – CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES – SUBCHAPTER H–MEDICAL DEVICES

Subpart M–Records

Sec. 820.184 Device History Record.

Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish
and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to
demonstrate that the device is manufactured in accordance with the DMR and the requirements of
this part. The DHR shall include, or refer to the location of, the following information:

(a) The dates of manufacture;

(b) The quantity manufactured;

(c) The quantity released for distribution;

(d) The acceptance records which demonstrate the device is manufactured in accordance with the
DMR;

(e) The primary identification label and labeling used for each production unit; and

(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device
identification(s) and control number(s) used.

[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]

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