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.

:confused:

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).

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

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.

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

:thanx: 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.

:D 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?

:thanx: 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.

:D 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.

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

Or do I have to delve into each standard and pull out applicable paragraphs for each checklist item?

MelYes, notice the heading,Specification/standard
Subclause/reference

So what will that look like? For instance;General Requirements 1.: ISO13485-2003 7.3;
for 2. 13485-2003 7.3 and 14971 4.2...
Looking at the checklist from MDC it says "Reference to Documentation". Is that our particular Procedure in our QMS that relates to those standards? Is that different from the Subclause/reference you mention?

So what will that look like? For instance;General Requirements 1.: ISO13485-2003 7.3;
for 2. 13485-2003 7.3 and 14971 4.2...
Looking at the checklist from MDC it says "Reference to Documentation". Is that our particular Procedure in our QMS that relates to those standards? Is that different from the Subclause/reference you mention?What is MDC?

From an email reply from Mel Kimsey:

MDC is just one of the consulting firms that provided an "Essential Requirements Checklist" online (see http://www.mdc-ce.de/ce_ive6.htm) . There are a few of them online, I just chose this one. As you mentioned long ago, we may as well use those forms and documents publicly available. It looks like it's a "fill in the spaces" form for fulfilling the Essential Requirements questions.

From an email reply from Mel Kimsey:

MDC is just one of the consulting firms that provided an "Essential Requirements Checklist" online (see http://www.mdc-ce.de/ce_ive6.htm) . There are a few of them online, I just chose this one. As you mentioned long ago, we may as well use those forms and documents publicly available. It looks like it's a "fill in the spaces" form for fulfilling the Essential Requirements questions.

I tried the link and clicked on the Checklist, I got: "The page cannot be found. The page you are looking for might have been removed, had its name changed, or is temporarily unavailable." Maybe it is just my company's security preventing me from reading the PDF file. I can get to their website and look at some of the other links.


Added in: I tried the link on my personal computer and now I get this message: "Not Found The requested URL /downloads/224001_e.pdf was not found on this server."

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?

I don´t think this checklist for a technical file would be the best way to put standards and clauses, simply because the number of hazards situations might transform this checklist in a book. Anyway ou already has to have, if following ISO 14971, such a document - your risk management file. I would advise putting on this essential requirements checklist just the standard and link to the RMF. This, by the way, is what is done on document ISO/TR 16142:2006
Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices.

Straighforward questions:

Does FDA consider the DHF a "living document", e.g. needing to be constantly updated with revisions to procedures contained or referenced therein?

Same question regarding Technical Files: Snapshot of a point in time, or a living document requiring the aforementioned revisions?

I tend to see these documents as the high level documents defining the system/product/device. In this aspect, as the regulations are worried about keeping the device safe in the device lifecycle, any changes to the devices (mainly inside the risk management process) would have to be updated. So, these would be "living documents" as you say.

Al,
In my experience, the Notified Body auditors I have worked with seem to strongly prefer an actual Technical FILE, e.g a big book (or books) where they can sit down and page through all the required documents. Utilizing an index where some documents are on a server, others in file cabinets, etc. always seems to be "less-than-seamless" and leads to confusion. What has your experience been in this regard?

Thanks!

Al,
In my experience, the Notified Body auditors I have worked with seem to strongly prefer an actual Technical FILE, e.g a big book (or books) where they can sit down and page through all the required documents. Utilizing an index where some documents are on a server, others in file cabinets, etc. always seems to be "less-than-seamless" and leads to confusion. What has your experience been in this regard?

Thanks!I kept copies of some of the documents in a file with the index and others were on a server or other locations. During our surveillance audits they reviewed the file and having the index was helpful. Every 3 years our NB randomly chose a Tech File to review and I had to send a copy of the File to the Notified Body in the EU. It's whatever you want to do as long as the file is available in a reasonable amount of time. I can tell you that it took me a lot less time to gather the documents than it took them to review it and request CA for minor NCs. I had to send them the corrections before they reissued our cert.

My question is in regards to both the FDA requirement for a DHF and the EU requirement for a Technical File:

"Are the DHF/TF snapshots in time - or living documents?"

I know this sounds very simplistic, but I've not seen this specifically clarified.

My sense is that the TF is intended to be a "living document", as our Notified Body requires that it be "revision controlled".

Whereas the FDA DHF appears to be more a "snapshot in time", with the change control process documenting subsequent design changes. Per the FDA Small Manufacturers Guide: "The DHF...will contain historical revisions of key DMR documents that show how the design was evolved". The reference to "historical documents" again points to it being a "snapshot/static" document.

Comments from experience will again be very much appreciated!

This debate always seems to me to miss the point. Why the FDA, EU, or any other regulatory requirement / authority needs this kind of document? The point is, these agencies / requirements are worried about the safety of the device, and one of the needed things are documents which reflects the design specifications, to guarantee that the produced device is in fact safe. Does it need to be updated? Well, think about the other fact, that safety is based on the risk management of the device, and you will conclude that everytime you update you risk management (for example due to a risk identified in the post-production phase) you also have to update any other technical documentation related to the device which is aimed ad controlling the risk (for exampe, putting information for safety on the accompanying documents, declaring the residual risk in a marketing document, or, updating the design specifications.

I have read several thread about technical file, but can anyone give me a example technical file for Construction Product Dierctive (CPD)...

thank's in advance.
sincere
TYW:thanks:

Tx! This is great for TF compilation