EU MDR and PSUR (Periodic Safety Update Report)
- Thread starter pdzip2
- Start date
There is a template for the PSUR, which is nice because takes the guessing out of how this this thing should look. I cannot figure out how to post a thread here, need to figure that out. My question is given the scope of the new EU MDR, why would a PMS PLan be required for a device that is not even sold/marketed in the Union? EU is concerned about devices in their jurisdiction, versus a China only product, what good is a PM PLan for that if its not even distributed in EU?
I hope you can share it. I'm preparing the plan for MDR transition and PSUR is totally unknown for me.
FoGia
Involved In Discussions
There is no template currently for PSUR in the frame of the MDR. I guess you are referring to the guideline from the European Medicines Agency (which is not applicable to medical devices): http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf
FoGia
Involved In Discussions
From what I've heard PSURs will need to be submitted - even via e-mail if it needs to be - even if Eudamed will not be ready, and they will be required to be on file as from November 2020 (for all devices).
A
Acme22
Any one have an Update on any MDR 2020 PSUR template / Guideline?
E
Eli15
Unfortunately, the European Commission has not released any template for the PSUR yet
J
Jnks_Meddev
Since the guidelines or templates arn't available - Are we waiting to write SOP until then?
R
RA Lille
I recently saw a Template… but did not get it… (unfortunately).
I also heard that PSUR Template could be edited by each national competent authority..
Has anyone any update on those 2 points ?
many thanks !
I also heard that PSUR Template could be edited by each national competent authority..
Has anyone any update on those 2 points ?
many thanks !
Sandesh K. K.
roYaL ridr
Does anyone have any update the PSUR Guidelines/ template?
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