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
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