Medical Device Directive 93/42 EEC - Clinical Trials - Because the auditor says so?

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Bridget

:mad: I am sure more than one of you has challenged the auditor to prevent a nonconformance? A nonconformance was written regarding the Medical Device Directive 92/42 EEC regarding clinical trials/investigations and I am trying to find the proof that substantiates this. We do not perform any clinical trials so the auditor wrote that “each technical file should state/reference the fact that no clinical trials are undertaken (Directive)” Can anyone point me to the section that states this must be documented in the Technical Files? By the way we have had these technical files since 1996 with no mention of this before.
Thanks, :thanx:
Bridget
 

Marc

Fully vaccinated are you?
Leader
I'm not a med device specialist. Any takers out there on this one?
 

Al Rosen

Leader
Super Moderator
Bridget said:
:mad: I am sure more than one of you has challenged the auditor to prevent a nonconformance? A nonconformance was written regarding the Medical Device Directive 92/42 EEC regarding clinical trials/investigations and I am trying to find the proof that substantiates this. We do not perform any clinical trials so the auditor wrote that “each technical file should state/reference the fact that no clinical trials are undertaken (Directive)” Can anyone point me to the section that states this must be documented in the Technical Files? By the way we have had these technical files since 1996 with no mention of this before.
Thanks, :thanx:
Bridget
Bridget:

You didn't mention the class of device or annex being applied. The MDD is somewhat complicated, but I will offer my "opinion". My belief is that if you do not run clinical trials, somewhere in your technical file you should state it so it is not thought to be an oversight.

Within your technical file should be an essential requirements checklist that addresses each of the annex I requirements. Clinical trials are addresed here. You can state it doesn't apply and why? Just like in your Quality Manual you would declare an exclusion.

We manufacture a device that does not require sterilization. Both the FDA and ISO13485 have a requirement for the sterilization process. I have a statement in our QSM addressing the requirement by stating we do not require sterilization. If you believe this is not necessary because the MDD does not explicitly state it, request that the auditor show you the requirement.

Anyway, it is easily corrected as I described above.
 
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Vincnet

Bridget,

I agree with Al.
I would even add that the Directives both 93/42 and 98/79 require you to have a performance evaluation for your product. It can be a bibliographic one based on published papers refering to your device or to a similar one. The standard EN ISO 14155-1 Oct 2003 or EN ISO 14155-2 Jul 2003 related to devices' clinical evaluation tells you how to built-up such a file from existing published work.

Vincnet
 
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wrodnigg

Bridget said:
Can anyone point me to the section that states this must be documented in the Technical Files? By the way we have had these technical files since 1996 with no mention of this before.

Bridget, could you please tell us, which Class your device is, and which Annex you follow?

Clinical evaluation is in fract mandatory only for implantable and Class III devices.

In all other cases the objectives of clinical investigation are (Annex X):
— to verify that, under normal conditions of use, the performance of the devices conform to those referred to in Section 3 of Annex I, and
— to determine any undesirable side-effects, under normal conditions of
use, and assess whether they constitute risks when weighed against
the intended performance of the device.

Annex I.14:
Where conformity with the essential requirements must be based on clinical data, as in Section I (6), such data must be established in accordance with Annex X.

Thus each manufacturer must demonstrate that his intended purpose(s) and claim(s) made in relation to safety and performance are achieved, as referred to in the Directives. As a general rule, such demonstration will require clinical data (Annex X, 1.1 of MDD).

More details are written in the MedDev 2.7.1:

You can follow the "Literature route" or the "Clinical investigations route".

But you may not omit "clinical data" in the technical documentation...


And a last point: The fact, that a product is on the market since 1996 does not implicate conformity with the MDD.
Regulations change (the MDD is under revision at the moment), and manufacturers have to change their technical documentation too (e.g. acc. to EN ISO 14971 since April 1.).
 
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Bridget

Further information

Sorry all, I should have been more precise with my initial post. Our products are Class I and Class II for use in the oral cavity only (orthodontics). We are certified to Annex II, excluding section 4.
I realize an auditor only reviews a sample of the documents at a time but I was disappointed to find that we were missing something as vital as this in the technical files after all of this time. It is written in other procedures that we do not perform clinical investigations so perhaps in the beginning it was written in the wrong place!

As I asked before could I just add a memo or ammendment to each file stating that we do not perform clinical investigations/evaluations and add it to each file? I am sure I could figure out a way to control the memo. I am slowly working toward improving each file and would hate to revise them now for only a sentence or two.
You folks are the best, Let me know what you think!
Bridget
 

Al Rosen

Leader
Super Moderator
Bridget:

Before you do anything, read annex X. According to Annex X 1.1.1, if you do not require trials to show you comply with annex I, 1 & 3 you need a "compilation of relevent scientific literature".
 
C

Cathy

Hi Bridget,

I am going to labour Al's last point here.

You say you just don't do trails/evaluations... if you are selling a medical device in the EU, you do, DO trials/evaluations.

If a device is brand new and there is nothing that performances/functions in a similar manner, you do clinical trials with this device.

If you are releasing a product that is quite similar to other device and it can be proved to have the same functionality and output, then you can do a clinical evaluation of data to prove the functionality, safety; etc is as required to market the device. This has been mentioned in the above posts.

You need to get your hands on the NB-MED’s and MEDDEV’s that have been released as guidance documents for the directive. If you don’t have them, give me a shout and I will send you the link for them.

However, you are right when you say you are missing an important of your technical documentation.
 
W

wrodnigg

Cathy said:
You say you just don't do trails/evaluations... if you are selling a medical device in the EU, you do, DO trials/evaluations.

If a device is brand new and there is nothing that performances/functions in a similar manner, you do clinical trials with this device.

If you are releasing a product that is quite similar to other device and it can be proved to have the same functionality and output, then you can do a clinical evaluation of data to prove the functionality, safety; etc is as required to market the device. This has been mentioned in the above posts.

You need to get your hands on the NB-MED’s and MEDDEV’s that have been released as guidance documents for the directive. If you don’t have them, give me a shout and I will send you the link for them.

100% Agree!

As I already posted above, Bridget should (hint! hint1 HINT1): read MEDDEV. 2.7.1 "EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES" because there is written what a manufacturer has to provide, and what notified bodies expect.
 
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Bridget

Thanks everyone

Thanks to you folks I now have a better understanding of what is needed. We have a lot of literature in the technical files and our products are similar to others on the market so I think we are fine there. However I will not turn down any future feedback in regards to the medical device directives since I do not have any contact with other medical device companies locally nor any training I can get to.
:bigwave:
Thanks a bunch,
Bridget
 
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