Anyone had an MDR technical file review/audit yet?

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Watchcat

Trusted Information Resource
#12
digitally signed PDF
That's some progress over ink, but I was thinking more along the lines of an entry in a database, rather than an actual certificate.

Actually, what would be quite cool is a link in Eudamed that took you directly to each device's CE information. Although, at this point, I guess we would all be thrilled if each device were actually in Eudamed. ;)
 
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MEa

Registered
#13
Our Audit was last year in December. Unfortunately we are still waiting for our certificate. We are manufacturer of class IIa medical devices in Germany.
The Tech file review lasted about 3 month. Our NB is TUV.

I recommend an intensive exchange with the notified body and the responsible auditor. This helped us a lot!

Important topics are:
-Vigilance
-Post Market Surveillance: PMS, PSUR, PMCF
-UDI, MDRLabeling
Hi sornas96,
Did you update the Clinical Evaluation Report and the Risk Management for each device for the audit? Did you do the benefits/risk ratio? Do you use the FDA guidelines on this?

Thanks!
 
#14
Hi sornas96,
Did you update the Clinical Evaluation Report and the Risk Management for each device for the audit? Did you do the benefits/risk ratio? Do you use the FDA guidelines on this?

Thanks!
Hallo MEa,
No, we had taken one product from our product portfolio and made it MDR compliant. Our other products are still according to MDD. Therefore we have updated the clinical evaluation plan and report and risk management for only one product or for the superordinate product group.

Yes we also use the FDA guidelines.
 
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