Medical Device File Requirements (ISO 13485 Cl. 4.2.3)

[Sam Lazzara]

Moderator Note - I think there is an existing thread that discusses this topic but I was not able to find it. Please feel free to move this post.

Some people (including me) have been confused about Medical Device File (MDF) requirements per clause 4.2.3. I think this is because the contents listing (4.2.3.a through f) appears to be more narrow than what the first sentence of 4.2.3 specifies.

At first glance (especially if you skip over the first sentence), the contents listing (4.2.3.a through f) appears to be the equivalent to what FDA calls the "Device Master Record" (DMR). This interpretation is supported by the fact that device Instructions For Use (IFU) typically include a general description of the device and its intended use as required per 4.2.3.a.

However, the first sentence of clause 4.2.3 indicates that the MDF contains/references all documents needed to show conformity and compliance with ISO 13485 and regulatory requirements, respectively. That is very broad indeed!

This has become such a broad concept that it leads me to believe that all QMS documents (including records) are what comprises the MDF.
From my perspective, all of the QMS documents combined are needed to demonstrate conformity with ISO 13485 and compliance with regulatory requirements (what the first sentence of 4.2.3 requires).

Side Note: The recently published ISO 13485:2016 Practical Guide makes it very clear that the MDF is a very broad, lengthy set of documents. So at least I think we can extinguish the myth that it is the same thing as an FDA DMR.

Am I going crazy? (serious question)
Are is it just ISO TC210? (just kidding)

 

[Ronen E]

Hi Sam,

I remember the thread you are talking about; I looked for it for a bit (I thought it also mentioned DMRs so I searched Elsmar for “Device Master Record”), but I couldn’t find it too... I’ll try to look for it again later.

Edit December 13 2017: While looking for something else I found that thread: ISO13485:2016 Clause 4.2.3 - Changes in Technical File Requirements

I don’t yet have a copy of the ISO 13485 practical guide (“handbook”) so I can’t relate to what they say in there.

To me, the key phrase is within the 1st paragraph of 4.2.3:

“...documents generated to demonstrate conformity to the requirement...

(My emphasis)

That is, apart from including elements a through f (quite straightforward), the MDF has to include some documents generated for the purpose of demonstrating conformity. To me the obvious solution would have been creating a cross-reference list, where the requirements (for example, of ISO 13485:2016; other documents may contain other relevant regulatory requirements) are listed, and pointers / brief explanations are provided for each to demonstrate that indeed the manufacturer / device / device family conforms / complies.

Again, this may not be in line with the new handbook, but this is how I would read this clause.

FWIW.

Ronen.

 

[rob73]

Ronen
I would agreed with you, we will (and always will) only include actual documents specific to showing conformity to MDR/13485 in the technical file, like design verifications and validations. Other documents like process instructions, inspection procedures and the like are referenced using tables. Can you imagine each technical file containing a copy of the quality manual as well all your system procedures, a papyrophiliacs dream!

 

[Philip B]

We have just been audited by our consultant in preparation for our first audit by our NB against ISO 13485:2016 in a couple of weeks. He raised that we do not have a medical device file. I pointed out that the requirements of the clause are met by either our QMS or technical file but he seemed to think we needed something else and that it has been written to be closer to FDA requirements. We don't sell in the US so have no experience of this. I still have no idea what to put in a medical device file other than duplicating existing documents. Any help would be gratefully received, thanks

 

[SpartanBio]

First off, so glad this forum is back and that I found it again.

I had the same feeling as Sam, I thought the MDF was the same as the FDA DMR and hadn't planned on making any major changes to the process. Now after reading this I'm slightly concerned.

I did think about creating the cross referenced document as well but now I'm not sure what to do. Hopefully a few more people have been audited to the new version and can chime in.

 

[Ronen E]

We have just been audited by our consultant in preparation for our first audit by our NB against ISO 13485:2016 in a couple of weeks. He raised that we do not have a medical device file. I pointed out that the requirements of the clause are met by either our QMS or technical file but he seemed to think we needed something else and that it has been written to be closer to FDA requirements. We don't sell in the US so have no experience of this. I still have no idea what to put in a medical device file other than duplicating existing documents. Any help would be gratefully received, thanks

Hi,

“Have no fear little fish...”

These days auditors seem to require spoon-feeding with everything, and I think this is what your consultant is bracing for. No drama, all you have to do is create a file (either a physical one or a computer file, as long as it’s properly controlled) that will provide all the necessary pointers to documentation already existing and residing elsewhere. The only element you might still be missing is the compliance cross-reference I mentioned earlier. If this is the case just create it and either physically include in your new MDF or provide a reference to its location for easy access.

Good luck,
Ronen.

 

[Philip B]

Hi,

“Have no fear little fish...”

These days auditors seem to require spoon-feeding with everything, and I think this is what your consultant is bracing for. No drama, all you have to do is create a file (either a physical one or a computer file, as long as it’s properly controlled) that will provide all the necessary pointers to documentation already existing and residing elsewhere. The only element you probably might still be missing is the compliance cross-reference I mentioned earlier. If this is the case just create it and either physically include in your new MDF or provide a reference to its location for easy access.

Good luck,
Ronen.

Thanks Ronen, doesn't sound too bad. Our NB have advised that they will not raise major NCs against the requirements of 13485:2016 on the first audit so that helps!

 

[locutus]

Thanks for this thread Sam, I think this is one of those "discussion" points that is going to occur over and over again between different people, different organisations, and different Notified Bodies. First, I heard a couple NB auditors state that they will be looking for the "Medical Device File" and a procedure that describes how this is generated, controlled, reviewed, and maintained. So sad to say as Philip as mentioned, auditors will be looking for a discrete Medical Device File. If you show them the Technical File or the DMR and say 'Here it is !' Unfortunately, will have to have a "regulatory dance" or discussion around this to avoid a non-conformity, because as rightly said some (not all) auditors need to be spoon-fed and only follow checklists.

When I view the documentation related to products in the QMS, I can not create a little graphic in this space, but my thoughts are:

Design History File (the all encompassing information) >
Technical Documentation (for those MDR people this is alot of info now) >
Medical Device File (which is still quite product related information, but maybe more) >=
Device Master Record (can the MDF and DMR be the same? probably) >
Technical File (there can still be a technical file, but it is usually reference index) >
Device History File (DHF is only for a specific product or batch)

I would argue that you can have an MDF/DMR that is exactly the same documentation structure, format, or content. Just as noted above and by Philip, just call it the MDF/DMR because FDA will want to see your DMR procedure and DMR and NB will want to see your MDF procedure and MDF. Cheers and good luck !

 

[Wolf.K]

We have been audited according to 13485:2016 last week, and the "medical device file" was not a problem. We have SOPs for the country-specific documentation requirements ("development of device master record" for the USA, "development of technical file" for EU), and in our quality manual we have added a chapter "medical device file" and just reference the SOPs. For our NB that was ok.

 

[Ajit Basrur]

Thanks Ronen, doesn't sound too bad. Our NB have advised that they will not raise major NCs against the requirements of 13485:2016 on the first audit so that helps!

Really ... that's cool