Should PMS and PMCF plans be 2 separate documents?

[Talia]

Hi everyone,
We have an endless discussion regarding the PMS and PMCF plans.
Our product is a class IIb device that has been on the market for a while .
We were told that since the PMCF plan is part of PMS Plan, we do not need 2 different plans.
Others interpretate this differently, as a requirements of having 2 separate documents.

Does anyone have a good answer? are there any regulatory references?

Thanks

 

[Cloud808]

We are in a similar position with Class I, IIa, & IIb legacy devices. I have not identified any firm answers through reference documents, though I can offer some anecdotal evidence.

Our position had been to combine the PMS + PMCF plans (as well as the PMSR/PSUR + PMCF Eval Report). We recently received notified body feedback that suggested there was a lack of clarity between PMS & PMCF. The comments did not specifically indicate that combining PMS & PMCF was the issue; however, we separated PMS & PMCF into individual plans/reports as a part of the response. We are still awaiting feedback on this and I will update with more info once we have additional feedback.

 

[Talia]

We are in a similar position with Class I, IIa, & IIb legacy devices. I have not identified any firm answers through reference documents, though I can offer some anecdotal evidence.

Our position had been to combine the PMS + PMCF plans (as well as the PMSR/PSUR + PMCF Eval Report). We recently received notified body feedback that suggested there was a lack of clarity between PMS & PMCF. The comments did not specifically indicate that combining PMS & PMCF was the issue; however, we separated PMS & PMCF into individual plans/reports as a part of the response. We are still awaiting feedback on this and I will update with more info once we have additional feedback.

Thanks so much! Would love to hear the additional feedback once received.
Enjoy the rest of your day

 

[EmiliaBedelia]

I have seen PMCF identified as part of the clinical evaluation process, and also as part of PMS. I think the key is to clarify that there are separate activities/actions being taken as part of each. It is not sufficient to rely only on "reactive" post-market surveillance (ie, complaints and adverse events) to demonstrate that your products are safe. You need to collect proactive evidence and assess state-of-the-art clinical information to show that your device continues to meet your own internal performance specifications, but also to show that it is beneficial when considering alternative therapies - and all that information should be collected in the CER and updated routinely.

So, as long as your plans sufficiently explain both sides of these activities and explicitly detail which is which, I think you could justify combining it as part of the PMS plan or as part of ongoing clinical evaluation updates. YMMV based on your notified body, as I think this is something that will vary between NBs/reviewers.

 

[Talia]

Many thanks Emilia! I guess the specific NB expectations definitely play a role.
Have a great day

 

[Ronen E]

Strictly speaking, there are no hard and fast "formatting" requirements around this in the MDR, i.e. both a combined and a separated approach should be acceptable. As long as the contents requirements are met, and there is sufficient clarity about how the plans meet the word of the MDR, that should be fine. Having said that, NBs have the last say in it, and your specific one must (practically) be satisfied; so if they end up feeling confused, you are not in a good place.

I'd suggest going with whatever makes sense to you, and adding plenty of clarifications what is what, and which element satisfies each clause in the MDR; and then paying close attention to your NB's feedback. Rinse and repeat. Sadly, there's no easy/clearer way about it, apparently.

PMS, CER and PMCF are painfully spaghettied together.

 

[Talia]

Thanks so much Ronen! vey helpful

 

[kaitybarry]

Hi Talia,

You've gotten some great info from the posters already. I'd like to add some perspective from someone who has passed an MDR audit recently (as the PRRC for post market surveillance).

We are a manufacturer of Class IIb devices as well. When I developed the Post Market Surveillance Plans (PMSP), I included our Post Market Clinical Follow-up (PMCF) Plan as well. When it came time to generate the Periodic Safety Update Report (PSUR), I included the results of PMCF. Granted we don't do much for our PMCF, as we are a legacy device and also a component of a larger medical device (CT scanners). It's mostly a market and literature review, no actual clinical studies. Our NB reviewed the report, and deemed it acceptable and compliant to the requirements of Article 86.

So, in all, we have two documents in our technical documentation: the PMSP with PMCF Plan, and the PSUR with the results of PMCF. @Ronen E is correct in saying that formatting isn't technically important, it's just ensuring that all the requirements are met. However, we always take into consideration what the NB sees - make sure that your information is presented in a way that is easy for the NB to digest so they don't have to go digging. If information is muddled, or there aren't clear conclusions for the data presented, it may be a red flag to the auditor.

Just my two cents!

 

[Talia]

Many thanks @kaitybarry - this is so kind of you! We've decided to have the PMCF plan integrated within the PMS plan - hopefully our NB will be satisfied as well