Clinical Evaluation Reports per the new MDD 93/42/EEC amendment

Q

Quality Mom

#11
Marc, did you write to me? Quality mom, I am really bad at discussion groups and who is writing to whom? If you did write to me what did your response mean?:notme:
 
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B

Burgmeister

#12
Two Questions:

I have a Class 1 U.S Exempt ; Class IIa EU device. Do we need Clinical Investigations? I mean it is really a requirement for Class IIa?


Thanking you much,:truce:
Not necessarily, you could get away with a Literature Review as your clinical evaluation. Depends on whether you can claim similarity to your device (predicate in FDA terms).

For those struggling with the whole Clinical Evaluation thing a good guideline can be found here: http ://ec .europa .eu/enterprise/sectors/medical-devices/files/meddev/2_7_1rev_3_en.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
 
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M

MIREGMGR

#13
Note that MEDDEV 2.7.1 Rev.3 (December, 2009) in Appendix F "Clinical Evaluation Checklist for Notified Bodies", in part 0, provides guidance to auditors for evaluation of demonstrations of conformity without clinical data, based on performance evaluation, bench testing and/or pre-clinical evaluation.
 
R

Roland Cooke

#14
Two Questions:

I have a Class 1 U.S Exempt ; Class IIa EU device. Do we need Clinical Investigations? I mean it is really a requirement for Class IIa?

Also, the client wants to use the first pre-validation units ( manf in production) for clinicals on Humans; before the results of the 60601 testing for safety. Do we allow this?

Thanking you much,:truce:
Clinical Investigation = Clinical Trial

Clinical Investigation =/= Clinical Evaluation

A clinical evaluation can include review of the outcomes of one or more clinical trials (aka clinical investigations).

The emphasis has changed for Class III and implantable devices: you need to justify why you didn't do a clinical investigation.
 
T

TgBln

#15
Hi,
I´m very new to this forum and I urgently need help! :truce: I have no hands-on experience, and - as life is - I have to prepare clinical evaluations for products which appear to be of class II. The Client hasn´t provided any further information and I think that before I prepare a timeplan and a financial offer I need to know if there are clinical studies or clinical data available. Is this correct? Beside this, I would really appreciate if anybody could post a template for a clinical evaluation! Is this the same than a clinical evaluation report? How long is it supposed to be for a class II product? While reading the MedDev guidance, it looks like a real report... May I just structure may report or is there any nice template available? I don´t know yet how many cases I will find in the literature, but I don´t think thew will be a lot... Please help me! :yes:
Thanks a lot! :thanx:
TgBln
 

pkost

Trusted Information Resource
#16
There are a couple of issues you may wish to consider:
1. You say you have no hands on experience - the notified body will check to see that the author is competent and reject it if the author is not - you may have difficulty justifying this
2. "appear" to be class II? is that IIa or b...they shouldn't appear...they should be, you need to know!

You shouldn't just be considering clinical data/peer reviewed articles, you should also examine competitive products or anything that is relevent in order to assist you with demonstrating compliance with the essential requirements.

As a general template I typically populate the following headings:
Clinical evaluation process (identical for each evaluation) and copied from MEDDEV
Scope
Author Biography
Search terms
Justification of data exclusion
Clinical Data/PMS of our product
Competitive products
Regulatory reports (FDA MAUDE, MHRA, etc)
Peer reviewed literature
Summary/Conclusion

With regards to length, that is very subjective and is very dependent the amount of information available to you.
 
S

SteveK

#17
Hi Tgbin,

As indicated by pkost, how can you conduct a clinical evaluation for a client without any prior knowledge of the subject and it would appear class of device? It might be useful to know the context of your situation. For example have you started work for a consultancy company and have been thrown in at the deep end?

Steve
 
T

TgBln

#18
Hi Tgbin,

As indicated by pkost, how can you conduct a clinical evaluation for a client without any prior knowledge of the subject and it would appear class of device? It might be useful to know the context of your situation. For example have you started work for a consultancy company and have been thrown in at the deep end?

Steve
Hi SteveK,
you´re right, it sounds all quite confusing, sorry! :( I am working in a contract research organization as a medical writer, I have learnt some basics about medical devices in the context of an educational program, but as I said, I have no hands-on experience. My company is going to prepare an offer for a Client who is interested in clinical evaluations for a product group of class II (my rough estimation of these products). I have been involved in preparing the offer as I am supposed to be able to estimate how time- and resource-consuming such a project would be. :mg: The problem is that I don´t know anybody who has already prepared clinical evaluations! I could find on INternet only very scarce and fairly different hints, so I don´t know if this evaluation (including literature search) is going to become a long report (~100 pages) or just a few pages, as I thought when I had a look at your posted evaluation... Could you help me? I am particularly interested in a template or structure which I could follow... Of course I would/will just prepare the document, make literature search and put data together, but we will engage an experienced evaluator for the actual evaluation and the risk-benefit assessment. I´ll be very grateful for any hint!!! :thanks:
Kind regards,
TgBln
 

pkost

Trusted Information Resource
#19
The time and cost of a clinical evaluation is very product dependent. Giving two extreme examples:

Bone screws have been in use for many years, there are many international standards and quite a few harmonised ones which you can use to demonstrate compliance with the essential requirements. Consequently there are not many essential requirements that you have to use a clinical evaluation to support your demonstration of compliance. Additionally because they are so well known a lot of the issues have previously been identified. The author of the evaluation should be able to use their experience to highlight the main issues, summarise a few key points from articles and regulatory reports and voila you are done in a few pages, for instance (I'm guessing at these figures) a search of MAUDE will return 1000's of references to bone screws. The author could say that he has reviewed 100 and 80% relate to the head rounding out, 20% to the screw backing out..it can be justified that the sample of 100 is sufficient to identify all but the most obscure of problems

However, if the product is relatively "new" and high risk with less data, lets say a total ankle replacement coated with a HA coating for fixation and TiN for the wearing surfaces then it becomes much more problematic and time consuming because there needs to be more depth to the review...You may only have 500 MAUDE reports on total ankle replacements, but it is a lot more difficult to justify not examining all of them - there are a lot less so it is not so much of a burden, but also, more importantly, because ankle replacements are "newer", it is much more likely that there is an issue the author is unaware of. On top of this the author should also probably examine HA and TiN coatings used in other joint replacements, suddenly what was a few pages for bone screws becomes 10's if not hundreds for a total ankle...both are class IIb!




The other factor that determines the length of the review is the time frame. If this is the first "proper" clinical evaluation then you will have to review all of the relevant data from a suitable time period...maybe when the device type was first introduced?... If an evaluation has already been completed then you only need to review data from when that one was completed-there is no need to review things twice!

One last thing - don't forget to feed the output of the clinical evaluation back into the risk assessment/management!
 
S

SteveK

#20
Hi TgBin,

As usual pkost has given an excellent answer – to summarise - “horses for courses” unfortunately. All our products are classed as non-invasive (class IIa/IIb – MDD Annex IX rule 11 mainly) and typically my clinical evaluation reports are about six pages long (with a risk management file circa 14 pages) – as you have already seen. So perhaps one starting point on the possible complexity involved will be which classification rule that the particular device falls under, not just the class itself.

Steve
 
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