Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD

#1
Our device is currently classified as Class IIa under the MDD, and we have a valid certificate for the next few years and don't plan to transition the device to MDR at this time. However, based on our gap assessment, the device will be up-classified from IIa to IIb under MDR. Given that the MDR PMS requirements go into effect on May 27, what rules should apply for PMS/PSUR update frequency, class IIa or class IIb?
 
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#2
According to MDR Article 86 Periodic safety update report(PSUR):
- Manufacturers of class IIb and class III devices shall update the PSUR at least annually.
- Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
 
#4
As you are selling now a class IIa device (under MDD, because your MDD certificate is still valid), you should apply requirements for class IIa. Check the question/answer 16 in the attached document.
Thank you very much Cybel, this is very helpful!!
 
#5
Hello everybody,
I hook up to this thread re. the frequency of PSUR (and also to SSCP for class III).

That's 1 year.
However, for legacy devices under MDD, who knows when the clock starts?
Could be the 26 May 2021?
Is there any official reference/guidance for this info?

Many thanks to all!
 
#6
There is no guidance or reference to stipulate that the PSUR is mandatory for device under MDD. But before the annual audit by NB, it's better to prepare this part. The auditors always ask: " Is there any evidence to prove that your company is preparing the MDR, such as PMS, PMCF, PSUR, or essential requirements input?" Of course they can't give you NC because of PSUR, but it will be a "Suggestion" indicated in audit report.
 

QM_123

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#7
Hello,

Two of my customers (one is class III and other class IIb implant manufacturers) got nonconformities on PSUR. Their NBs are different. First NB accepted identification of PSUR in the procedure to close NC. However other NB didnot accept although it has been identified in the procedure, auditor require PSUR report and more a "PSUR Plan". Actually it makes no sense to me becuase as I know PSUR is a report basically includes the outputs of PMS activities, so we have already a PMS plan. Even so, is an additional "PSUR Plan" required with a PMS plan?
 
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