EU MDR and PSUR (Periodic Safety Update Report)

#1
MDR Article 86 Periodic safety update report reads:

1.Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. ...


Two questions:
1. PSUR is a well known requirement in the pharma world (see attached template from EMA (virus scan before use )). Is it now required for all medical devices in class IIa or higher even if they do not administer medicinal products?
2. Does anyone already have a decent PSUR template and is willing to share it?

Many thanks to the loyal readers (and am I glad that Elsmar is back)
 

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yodon

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#2
Well, I was hoping someone with expertise would reply but maybe this will help move the discussion.

My understanding is that the PSUR is new to the MDR and it will be required for Class IIa, IIb, and III.

As far as the content of the report goes, just a little further down in Article 86 says:
(a) the conclusions of the benefit-risk determination;
(b) the main findings of the PMCF; and
(c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Then running the thread, the PMCF is addressed in MEDDEV 2.12/2 rev 2. I guess that cover a pretty wide range of things so maybe a template would be difficult?

Hopefully someone has cracked this nut and can share / enlighten. (I'm glad you asked the question!).
 
#4
According my information the European Commission will release a template for the PSUR. Should have happened in December, but as so often they are delayed. Let's hope it will come soon. I personally am waiting with drafting a template.
 
#5
Thank you all for this discussion and input on PSUR. Here are my insights on PSUR being into the EU MDR field.

First of all, Yes, PSUR for medical devices is now a requirement for MDR compliance.

PSUR will be required for all devices classified as IIa, IIb or III. The scope is not limited to just for devices that are intended to administer and/or remove medicinal substances. This requirement will impact all devices (including custom devices) except class I. (As a side note, class I devices will still require PMS report and should be a part of Technical Documentation; Class I PMSR should be updated when necessary and should be made available to the competent authority when requested by a manufacturer).

An Annual update will be needed for PSURs falling under class IIb and III. A bi-annual update will be needed for PSURs falling under class IIa. (for class IIa, the PSUR update can be earlier than 2 years depending on the changes)

All PSURs will be required to be the part of Technical Documentation (Currently, termed as technical File). PSURs for custom devices will be required to be the part of its documentation (not formally termed as technical Documentation for Custom Devices).

PSURs for any class III or any implantable device will be required to be submitted to NB through EUDAMED for review and assessment. It is not clear to me whether a manufacturer or an NB will be required to submit this evaluated PSUR to Competent Authority but I am sure that it should be made available to the Competent Authority after NB's review. (Further reading Art. 86(3) gives a little more clarity that it mostly should be a manufacturer).
PSUR for any class IIa/IIb (non-implantable) devices will be required to be submitted to NB under conformity assessment review and to the competent authority, only when requested.

Hope this is helpful!
Thanks.
 

jiligan

Involved In Discussions
#6
I am currently working on MDR and came across your post since I am looking for a template for the PSUR also. Have you had any luck finding one that will work for you? Thanks!
 
#9
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?

:bonk:
 
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