PMCF Plan and Eval Report used to replace updates of CEP and CER for legacy devices

[Ann-Sofie]

Hello, has anyone tried and used the approach to update the CER for legacy devices more seldom and use the PMCF (PMCF Plan and PMCF Eval Reports) as the continues 'PMCF surveillance'.
So for a class IIa or IIb the CER is planned to be updated every 5th year and in between there are two PMCF Plan periods of och 2.5 years with two PMCF Eval reports and the latter used as input for the CER at year 5. In case the PMCF Eval Report at 2.5 years indicates that there is something 'new' the CER needs to be updated at that time.

Instead of seeing the PMCF Plan and Report as 'extra documents' they are seen as light CEP and CER and do the PMCF monitoring and make it possible to only update the CEP/CER when there is really a need for it.

 

[Cloud808]

I believe the PMCF ER is supposed to be part of the CER (Annex XIV, Part B, (7)), so why not just update your CER every 2.5 years with the results of the 2.5yr PMCF data collection period. If the data does not result in any significant changes to benefit-risk determination or GSPR conformity, it shouldnt be a heavy lift to update the CER anyway. (And if there were changes to the determination you'd be updating CER anyway).

Also keep in mind 5 years is likely the max period you could go w/o updating a CER per MEDDEV 2.7/1, so your clinical data should be very very solid with no gaps in S&P claims or GSPR conformity and the device not likely to present any significant risk.

 

[Ann-Sofie]

I believe the PMCF ER is supposed to be part of the CER (Annex XIV, Part B, (7)), so why not just update your CER every 2.5 years with the results of the 2.5yr PMCF data collection period. If the data does not result in any significant changes to benefit-risk determination or GSPR conformity, it shouldnt be a heavy lift to update the CER anyway. (And if there were changes to the determination you'd be updating CER anyway).

Also keep in mind 5 years is likely the max period you could go w/o updating a CER per MEDDEV 2.7/1, so your clinical data should be very very solid with no gaps in S&P claims or GSPR conformity and the device not likely to present any significant risk.

Thanks for your response.
So your suggestion is not to write a separate PMCF ER after 2.5 years, in other words write a CER instead?
In MDCG 2020-6 Appendix I, section '6.2.3. Updating the clinical evaluation in MEDDEV 2.7/1' is not listed as relevant under MDR.
So is 5 years still the max period?

 

[Cloud808]

For sure!

Technically, my suggestion is that you do both. Consider the PMCF ER as a component of the CER. MDCG 2020-8 gives a nice template that can be completed based on your PMCF activities performed, where you can reflect the data collected for your 2.5yr data collection period. It can then be discussed amidst your other data within the body of the CER. If the data simply confirms your current conclusions about S&P claims, it should be a straightforward task.

Re: my '5 year max' statement - good point about MDCG 2020-6; However, I think the general principle of that MEDDEV section still applies in a sense. That section does begin with instruction to "define and justify the frequency" which is equally true under MDR. Whether 5 years is considered a true maximum or not, I think it may still be a fairly long time to go without any CER updates in the eyes of the MDR. Not at all saying you cant do it and be just fine, but if you *are* opting for a 5 year periodic update cycle, your clinical data should be buttoned up tight with no gaps in S&P claims.
The MDR does draw a line in the sand within Article 61 (11). If a device is class III or implantable, the PMCF ER "shall be updated annually" (and since the PMCF ER is part of the CER, thats implying annual CER updates). Now that's for your highest risk devices, so for a lower risk classification you can think about extending your update period (provided enough data to justify & proper vigilance procedures in place), which is the principle established by MEDDEV 2.7/1 6.2.3.

 

[ewan77]

Has anyone had any experience with this since last march or any feedback from their notified bodies?
If for example the device has long history of use, stable design with no signals from PMS, the PMCF-ER could be summarised and included in the CER, a review of inputs to document reviewed and conclusion updated?

Is a full literature search for SOTA and DUE required for every annual revision of the CER (where PMCF ER is on an annual schedule) or could it be justified the annual updates are more focused on that period and full update is completed every 4 years prior to recertification?

Any feedback companies have in the last year would be appreciated