Medical Device Technical File Confidentiality - On site reviews

#1
Hi!
My company manufactures MD since 1987, and for us it is mandatory to have all our Technical Files reviewed "on site".
This happens because of our confidentiality policy
As you all may understand, this is a matter very seriously for any manufacturer.

Now, my NB is asking us to send them the technical files because ""is mandatory for them to allow MHRA review their work".

On what basis? Is there any regulator document which specifically mentions that requirement?

On MHRA Guidance on legislation - Requirements for UK NB's, I found no information about that obligation.

Neither on,
NB-MED 2.5.1/Rec5, point 5 - Availability of the technical documentation. It only says "The technical documentation should be kept at the disposal of the Competent Authorities for inspection and control purposes. This obligation is incumbent upon the “manufacturer” within the meaning of the medical devices Directives who places the product on the market under his own name."

Or even,
new regulation (EU) 2017/745
"all parties involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:
… (b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights…"

Which argument could be used to dispute this "mandatory" requirement from NB?

Thanks
 
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Ninja

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#2
Howdy,

I am not in MD in any regard...but I've noticed that there are similar threads here on the cove asking the same question. You may want to look at some of those.

Try here for example...there are others...HTH
 

Ninja

Looking for Reality
Trusted Information Resource
#4
Again, I'm not in MD...
But the thread I pointed to gives various thoughts and approaches to how to handle Confidential Information when an AB requests that you allow it off site.
Perhaps others in the MD community will chime in for things specific to that arena.
It is a holiday weekend here in the USA...so you may have to wait until Monday...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Now, my NB is asking us to send them the technical files because ""is mandatory for them to allow MHRA review their work".
As always, if an oversight body, the NB in this case, tells an organization that there is a requirement being imposed onto them and they have to flow down on to their customers, they should be able to pinpoint the requirement, in a transparent way.

On the issue of the technical documentation review, depending on the complexity of the device and the risks involved, multiple disciplines and, potentially, multiple reviewers could be involved in the documentation assessment and that means a costly on-site review process. But, if the manufacturer is willing to bear the costs of having the review done on-site in order to minimize the risks of confidential information leaking, I don't see why the NB's could not accommodate the request.

NB's in the Medical Device field are all scrambling for resources to perform their duties in a timely manner and sending reviewer(s) on-site to a customer ties up these resources even more, as there is mobilization-demobilization time and inherent drop of flexible use of resources by NB. So, they might be trying to create an excuse for them to force the issue and have the documentation sent to them. Chances are, they can also try to make the on-site review cost prohibitive to the manufacturer, as a way to "convince" the manufacturer to relinquish the documentation.

Good luck.
 
#7
Thanks for your reply Sidney

Our TF was reviewed onsite 2 weeks ago.
Now, the NB is asking us to send copy of the Techical File by email. They said "is mandatory for them to allow MHRA review their work"

On what basis it is "mandatory"?
 

rob73

looking for answers
#10
The MHRA will from time to time require the review of technical files. Be it through your certification/notified body or directly fro the MHRA. We have had two requests from the MHRA for review of technical file. Basically it is their right to ensure that you and your notifed body are doing your jobs properly. As for confidentiality, the MHRA deal with a multitude of confidential information from medical records (during investigations) to technical files. take a look at Medical devices: the regulations and how we enforce them All information is dealt with in the strictest confidence according to the confidentiality provisions in Article 20 of the Medical Devices Directive (93/42/EEC)
HTH
 
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