Technical Files - Please explain differences and what information would be included

[DAMAS]

Hi,

Being new to this arena would some kind person please explain the difference and what information would be included in each of the Following,

Device Master Record (DMR)
Device History Record (DHR)
Design History File (DHF)
Technical File

Are some of the above one and the same or all totally different as I have seen reference to all in my endeavour to determine what goes in each file. We are designing and intend to manufacture a medical device delivering energy to the patient over intact skin. Require CE mark etc.

[MedQE]

Device Master Record (DMR): Contains all of the device specifications and procedures used for its manufacture. Typically only current (not obsolete) procedures,schematics, BOM's, etc. are kept here.

Device History Record (DHR): Is a compilation of the test results for each manufactured device. Each device (or lot) should have a DHF that fully describes the tests that were done, who did them, and date (complete traceability on all tests).

Design History File (DHF): A compilation of records that contain the history of the design, such as validations, verifications, qualifications, environmental testing, project plans, risk management activities, meeting minutes, etc.
Often this will include all revisions of a procedure, schematic, etc. so that as the development process evolves this traces the changes that were made.

Technical File: Only required for CE Mark (not an FDA thing). Its contents will include some of the items from the DHR and DHF, plus items not in the DHR and DHF, such as statements about substantial equivalence or clinical trials. Most important item in here is the Essential Requirements matrix. The lengthy list of items is described in the relevant MDD, perhaps MDD 93/42 in your case.

Hope this helps. You will also need a "UL File" if you want the device to be UL Classified or Listed, which is usually the case with medical devices. This is also a fairly large file with contents quite different than all the rest we have discussed (heavy on safety related material information).

[sal881vw]

Good morning Damas,
I have attached a "Technical file" that we use..........hope to be of help.

[Al Rosen]

Originally Posted by sal881vw

Good morning Damas,
I have attached a "Technical file" that we use..........hope to be of help.

Sal:
The Technical File you attached may be ok for the low voltage directive but it will not be acceptable for a Medical Device in acordance with the MDD 93/42/EEC.

Damas:
I have attached a Technical File Index that lists the contents of a Technical File and an Essential Requirements check list required for the MDD Technical File.

The index is one we use for our products. It may not be appropriate for your products or class device.

[sal881vw]

Originally Posted by Al Rosen

Sal:
The Technical File you attached may be ok for the low voltage directive but it will not be acceptable for a Medical Device in acordance with the MDD 93/42/EEC.

Al,
Thanks for the feedback, you are perfectly right.........I just wanted to pass to Damas a basic idea of the TF format

[DAMAS]

Thanks heaps Everyone for your very valuable information - I now understand what goes where as I was rather confused prior to my post. The sample Index, checklist and all the 'D' words being explained is excellent and is very much appreciated.

One question - where data is in a DHR or DHR and is also required in the Technical File (i.e. Duplicated) do you store it in one file and reference it from the other or have copies on both files?

[Al Rosen]

Originally Posted by DAMAS

Thanks heaps Everyone for your very valuable information - I now understand what goes where as I was rather confused prior to my post. The sample Index, checklist and all the 'D' words being explained is excellent and is very much appreciated.

One question - where data is in a DHR or DHR and is also required in the Technical File (i.e. Duplicated) do you store it in one file and reference it from the other or have copies on both files?

Damas:

It is not necessary to make a copy for the technical file. It is acceptable to just indentify the location. If you use something similar to the index, add a column with LOCATION as the heading. It will be quite acceptable.

[Mel Kimsey]

I think the checklist is great on this Technical File thread (Ess_Req_Ass_CHKLST.DOC) Can anyone give me a sample of the entries that might go in it? For our most recent audit I just had Applicable or Not responses for the ER in the TF, and as you know, that didn't fly. Will the entries on this checklist be basic like 60601-1/ISO 13485-2003/ISO 14971/ISO 10079-1...? Or do I have to delve into each standard and pull out applicable paragraphs for each checklist item?

Mel