PSUR - MDR First Submission Requirement?

Steve M

Starting to get Involved
#1
Hi everyone,

I was talking to a regulatory consultant earlier today and we brushed on the topic of the PSUR. She informed me that she had been advised that the PSUR isn't required for your first submission for the MDR and the CER will cover the data you would need as part of the PSUR. You will need to carry out the PSUR thereafter to be compliant, of course.

Is this assertion correct or do you still need a PSUR with your first submission of the technical file under MDR?
 
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yodon

Leader
Super Moderator
#2
That makes sense. For submission, you have confirmed, to the best of your knowledge (and have objective evidence) that the device is appropriately safe. The 'U' in PSUR *is* update, requiring field data to assess safety.
 

renenatasha

Involved In Discussions
#3
Hi everyone,

I was talking to a regulatory consultant earlier today and we brushed on the topic of the PSUR. She informed me that she had been advised that the PSUR isn't required for your first submission for the MDR and the CER will cover the data you would need as part of the PSUR. You will need to carry out the PSUR thereafter to be compliant, of course.

Is this assertion correct or do you still need a PSUR with your first submission of the technical file under MDR?
Yes, our NB informed that for initial submission, they'll be looking for a PMS Plan. PMR or PSUR comes later.
 
#4
Hello, just read this interesting post.
I have a question:
After 26 May 2021: until when you can avoid submission of PSUR (and SSCP for class III)?
In other way.
For class IIa the update is every two years, for IIb and III annually.
When does the clock start for submission? Could be from 26 May 2021?--> At May 2022 the NBs will be inundated with PSURs..

Many thanks for your attention!
 

Raisin picker

Quite Involved in Discussions
#5
Hi Marc,
You cannot avoid the SSCP (for devices that require it). You need to include it with the initial submission.

Regarding PSUR: I have the impression that the NBs are still a bit lenient. To date, the planned MDCG document on PSUR is not published, I think it is now announced for Q4/2021. Until then, neither do manufacturers know what to include, nor NBs what to assess.

Regarding clock start: It does start with initial submission for MDR. For legacy devices, discussion is still if the PSUR is required at all. If so, the clock started this May. If not, the clock does not start.

Remember to check MDCG 2021-1 for what to consider while EUDAMED is not running yet.
 

Billy Milly

Involved In Discussions
#7
Hi all,
Let me jump into the discussion.

For legacy devices, discussion is still if the PSUR is required at all. If so, the clock started this May. If not, the clock does not start.
As I understand the MDR, PMSR or PSUR are required. Article 120 allows legacy devices to be placed on the market (with a valid certificate), however PMS requirements of the MDR still apply - one of those is also PMS plan, which should require the preparation of PMSR or PSUR. That said, you should have the plan available from May and fist report within the prescribed period (two years, if I am not mistaken).

I would be glad to hear your opinions.
 
#8
Hello,
That's what I'm thinking for legacy devices.

-If you make MDR submission after May 2022, PSUR is expected latest by May 2022 (class III/IIb)
-If you make MDR submission before May 2022 and get MDR cert. after May 2022, the same as above
-If you get MDR cert. before May 2022, the clock starts at Cert. date

To be confirmed by your NB and waiting for MDCG guidance..

What do you think?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#9
Typically Notified bodies have an Industry Engagement point person. These are the types of questions they would handle. I suggest avoiding the technical team for this feedback and go straight to the Industry Engagement Team there.
 
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