Medical Device Technical File/Dossier (CE Mark) review - How many ?experts? available

S

SteveK

#1
Medical Device Technical File/Dossier (CE Mark) review - How many ‘experts’ available

There are circa 400 separate Medical Device harmonised Standards, plus various country specific standards.

Number of device variants – GMDN etc lists tens of thousands.

Number of device companies that supply CE marked devices – tens, hundreds of thousands?

Number of Technical Files/Dossiers - millions?

There are 19 members of Team-NB.

So how many ‘experts’ are there available in reality to review all the TFs out there; considering the above and the complexity of many devices (note: class III will include clinical trial data), i.e. to meet the current requirements of 93/42/EC (see clause 7, Annex II) on an ongoing basis?

One NB indicates a turn around of a TF review in 30 days. So if there are millions of TFs out there; even with this conservative estimate, that is an awful lot of man days!

I did not get a response on my previous post (Have you submitted a Technical File yet? Directive 2007/47/EC) on who had submitted TFs, what I was trying to get at is can NBs in practical terms cover the legal requirements of the Directive i.e. review (expertly) all the TFs in existence?

Or am I just being silly?

Steve
 
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pkost

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#2
Re: Medical Device Technical File/Dossier (CE Mark) review - how many ‘experts’ avail

review (expertly) all the TFs in existence?
You mention expert, not "thoroughly", which I think is a key point

edit: the NB does not have to review ALL technical files in existance, just an appropriately justified sample from each subcategory (in the case of IIa) and generic device group (in the case of IIb). This will significantly reduce the number of reviews necessary.
 
S

SteveK

#3
Re: Medical Device Technical File/Dossier (CE Mark) review - how many ‘experts’ avail

We are only a very small company and have 9 distinct categories/groups of devices (8 class IIa and one class IIb - defined by the fact that they conform to different standards). So what about multinationals etc? So I still think the numbers of TFs out there; that have to be reviewed as indicated in the Directive, is vast – so are there enough consultants, experts etc to ‘thoroughly’ review them?

Steve
 

pkost

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#4
Re: Medical Device Technical File/Dossier (CE Mark) review - how many ‘experts’ avail

If you look at the calculation from the other side....

A technical file review is allocated 1-2 mandays by our NB. This doesn't account for subsequent internal checks (i don't know how much time they take).

Therefore each "expert" can carry out between 126-252 reviews in a year (excludes weekends and UK bankholidays - some people have lives).


I don't and have never worked for an NB so don't know how they allocate and source their resources, but you pose an interesting question and I would be interested to see what someone who knows the inner workings of an NB thinks
 
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