Hello Maria,
It would be helpful to understand exactly what the Notified Body's query was in regard or reference to the PMCF. Also was it a query or was a nonconformity/observation issued? In regard to having a PMCF Plan, I personally have a problem with the literally reading of the regulation of Article 61 and Annex XIV, Part B having a PMCF Plan. My issue is, if I have sufficient clinical evidence based on source 1, 2, and 3, then I do not need source 4, 5, and 6 - as example if my nonclinical, clinical literature, and post market data support my safety and performance, then I do not need an equivalent device, clinical investigations or PMCF. In my CER I write my rationale for not having an equivalent device, not doing clinical investigations, and not doing a PMCF. I am still doing PMS, just not PMCF. However, many people take the regulation too literally saying because Annex XIV talks about a Clinical Development Plan and a PMCF Plan than you better have one !
Maybe for new devices yes, this would be appropriate. However, when we are talking about legacy, MDD CE Marked products, having been on the market for 5 or more years, what would be the sense or point of writing a Clinical Development Plan (for something which has already been developed years ago) and a PMCF Plan (when I have been collecting post market data for 10 years)? Sometimes I really question the thought process of individuals or more question why people blindly follow checklists. Please understand for new products being placed on the market in the last couple years or newly introduced to the market under the EU MDR, then I do see where sufficient clinical data may not be available and these activities would be more valid. Legacy devices and products on the market for 15 years, I still shake my head when Notified Body reviewers comment there needs to be a PMCF Plan. A PMCF Plan for what? A single piece of paper saying PMCF Plan which says "we are not doing a PMCF"? These can be sufficiently address in the CEP/CER for legacy products with legitimate sufficient clinical evidence without creating another document. In addition, each time we review our CEP/CER, we are still asking the questions: do we have sufficient clinical evidence? do we need to do a clinical investigation? do we need to do a PMCF? etc. These questions are still valid and should be asked each time we go through our clinical evaluation process.
To get back to your question, let me pose a question to your Notified Body? We take the premise you have a working, established, and implemented post market surveillance system. And your Class IIa product has been on the market for a few years. Why would you need to establish specific objectives for a Post Market Clinical Follow-up? You have already stated your point: '
We believe that a PMCF study isn't necessary for this Class IIa device.' From my perspective you have a rationale and justification exactly for your statement, so you do not need PMCF objectives. Why write objectives for something you are not doing? You only need to fulfil Annex XIV Part B if you have determined you need to do a PMCF.
You post the question: 'Any idea/example of how you would formulate a "research question" / specific objective for a Class IIa that does not require a PMCF study?' You would not. If you determine not to conduct PMCF, then nothing in Annex XIV Part B would be appropriate. Article 61 could have been written much better and hoping there will be further guidance documents on PMCF, not just some templates.------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Nov-2020 20:33
From: Maria Laitenberger
Subject: PMCF plan under MDR 2017/745
Dear RAPS network,
We received a query from a Notified Body regarding the PMCF plan we've included in our Class IIa Technical file submission under the MDR 2017/745. I am hoping to get some help from those who have prepared PMCF plans/reports under the MDR. In particular, I'm interested in the type and level of depth for the SPECIFIC objectives to be addressed by the PMCF for a Class IIa device.
We believe that a PMCF study isn't necessary for this Class IIa device. However, our understanding is that to fulfill Part B, 6.2(e) of Annex XIV, the PMCF plan still needs to have SPECIFIC objectives in place (which do not appear to be the same as GENERAL objectives such as evaluating safety/effectiveness, etc.)
We already consulted:
- MDCG-7 and -8
- SGS PMCF plan template found online: It seems that they refer to specific objectives as "research questions". Any idea/example of how you would formulate a "research question" / specific objective for a Class IIa that does not require a PMCF study?
I know the specific objectives will be very much dependent on the content of the clinical evaluation but it would be much appreciated if anyone could share insights or examples of how they formulated their specific objectives for the PMCF plan.
Thanks in advance,
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Maria Laitenberger, Eng., M.A.Sc., RAC
Regulatory Affairs and Quality Assurance (RA & QA) Consultant
New Zealand
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