Medical Device Technical File Confidentiality - On site reviews

pkost

Trusted Information Resource
#11
Article 16(4) states:
The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued. The notified body shall also make available, on request, all additional relevant information
I suspect that this is the clause that permits/requires this - I would argue that all documentation that is necessary to support the issuing of a certificate i.e. a technical file are relevent



This is not an argument you will win with your notified body.

There should be confidentiality clauses in your NB contract and also the directive is quite clear on confidentiality too. If you want to register your products elsewhere besides Europe, you may struggle if you are not willing to disclose your technical documentation
 
Elsmar Forum Sponsor
#12
Sorry for this new question but, as per 93/42/EEC as we are a portuguese company we must report to portuguese Competent Authority - INFARMED.
Why our notified body mentions Mhra? They are from uk be we are not...
Why we need to report to MHRA?
 

rob73

looking for answers
#13
Sorry for this new question but, as per 93/42/EEC as we are a portuguese company we must report to portuguese Competent Authority - INFARMED.
Why our notified body mentions Mhra? They are from uk be we are not...
Why we need to report to MHRA?
May be because your NB is based in the UK where the MHRA has jurisdiction? One thing to remember it is your NB being audited not you, your technical file is just required for the NB to evidence that they are doing their job properly.
 

dgrainger

Trusted Information Resource
#14
For the MDD - Annex VII 2
For MDR Article 10.8
You have to make the documentation available for the competent authorities for a period of ...

There are also requirements arising from 2013/473/EU on unannounced audits/assessments by NBs
 
#15
Thank you all
I already sent the TF to the Nootified Body, but only with general issues, not confidentials.
Thanks for your kind support
 
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