Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear community
Let's say one of your clients, a doctor, located in Europe, is using your device for large population triage (for example elderly house routine visits). The device measures several parameters and the client is willing to collect such data (including refernce measurements using routine equipment) and transfer it to us for our PMCF analysis- the data is transferred without any identification of the patient.
1. Would that be considered as private registry?
2. Do we need protocol for such PMCF activity? Informed consent? 
3. Do we need to approve such activity by the IRB and present in our PMCF report evidence for working according to GCP?

In general- are PMCF activities need to be approved by IRB? For clinical studies the answer is clearly yes, but what about other specific activities such as surveys, real world data collection?

Thank you for your answers!

"Europe" is a big diverse place and the MDR does not apply everywhere, so I'm going to assume that you mean the Union (in which the MDR applies).
I'm also going to assume that the device has CE mark since you are planning PMCF activity. Then it comes down to the protocol of the study: on label or off-label? Your question does not specify this.
If on label you're likely looking at an article 74 MDR study ('PMCF investigation') or 'other clinical investigation' under article 82 MDR. If the protocol is not in scope of either of these provisions, it can still be that national law on non-interventional research applies. Private registry is not an MDR concept, nor is IRB, nor is clinical study. You'll need to fit your protocol in the right MDR definitions to find out which pathway applies and what the requirements are for that pathway. I suggest reading up on Chapter VI MDR and taking a good look at the defined terms in article 2 MDR (or hiring a specialist to look at this for you).
If the data is going to the US (which I assume in this case) you'll have GDPR obligations even if patients are not identified but are still identifiable (these are different things) in the data set. Because there still is no new data transfer framework between the EU and the US because of the rather different approaches to protection of personal data, you'll need to take special measures for a compliant transfer (complicated).
So, lots of unknowns still here.

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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 31-Aug-2022 02:15
From: Anonymous Member
Subject: PMCF, Real World Data and GCP

This message was posted by a user wishing to remain anonymous

Dear community
Let's say one of your clients, a doctor, located in Europe, is using your device for large population triage (for example elderly house routine visits). The device measures several parameters and the client is willing to collect such data (including refernce measurements using routine equipment) and transfer it to us for our PMCF analysis- the data is transferred without any identification of the patient.
1. Would that be considered as private registry?
2. Do we need protocol for such PMCF activity? Informed consent?
3. Do we need to approve such activity by the IRB and present in our PMCF report evidence for working according to GCP?

In general- are PMCF activities need to be approved by IRB? For clinical studies the answer is clearly yes, but what about other specific activities such as surveys, real world data collection?

Thank you for your answers!

Dear user,
As Erik said, there's no "private registry" in Europe, and to be able to include these kind of data into your PMCF, a PMCF plan (protocol) should exist. Also, the data needs to be checked and cleaned, to fulfill GDPR requirements. Solutions exists, we can discuss this if you want, and I can advise on what should/could be done.
My contact : estelle.frappe@aetion.com
Kind regards,
Estelle

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Estelle FRAPPE
Director, Real World Solutions, MD&D
RUEIL MALMAISON
France
------------------------------

Original Message:
Sent: 31-Aug-2022 02:15
From: Anonymous Member
Subject: PMCF, Real World Data and GCP

This message was posted by a user wishing to remain anonymous

Dear community
Let's say one of your clients, a doctor, located in Europe, is using your device for large population triage (for example elderly house routine visits). The device measures several parameters and the client is willing to collect such data (including refernce measurements using routine equipment) and transfer it to us for our PMCF analysis- the data is transferred without any identification of the patient.
1. Would that be considered as private registry?
2. Do we need protocol for such PMCF activity? Informed consent?
3. Do we need to approve such activity by the IRB and present in our PMCF report evidence for working according to GCP?

In general- are PMCF activities need to be approved by IRB? For clinical studies the answer is clearly yes, but what about other specific activities such as surveys, real world data collection?

Thank you for your answers!

In addition to the useful replies others already gave I would like to add that, especially when the data will also be presented in EU documentation (clinical evaluation) you should apply GCP as far as possible. Post-market studies are within scope of the ISO 14155. Annex I of the same standard helps understand how the requirements can be applied. Moreover, MDCG 2020-6 (section 6.5e) will tell you that all PMCF activities should be clinically relevant and scientifically sound. This means your plans will have to include at least: "Clearly stated research question(s), objective(s) and related endpoints; An evaluation of potential sources of bias or study distortion, and the impact of these factors on the potential validity of results; Design with an appropriate rationale and statistical analysis plan; A plan for an analysis of the data and for drawing appropriate conclusion(s)."

------------------------------
Wiebe Postma
Vierpolders
Netherlands
------------------------------

Original Message:
Sent: 31-Aug-2022 02:15
From: Anonymous Member
Subject: PMCF, Real World Data and GCP

This message was posted by a user wishing to remain anonymous

Dear community
Let's say one of your clients, a doctor, located in Europe, is using your device for large population triage (for example elderly house routine visits). The device measures several parameters and the client is willing to collect such data (including refernce measurements using routine equipment) and transfer it to us for our PMCF analysis- the data is transferred without any identification of the patient.
1. Would that be considered as private registry?
2. Do we need protocol for such PMCF activity? Informed consent?
3. Do we need to approve such activity by the IRB and present in our PMCF report evidence for working according to GCP?

In general- are PMCF activities need to be approved by IRB? For clinical studies the answer is clearly yes, but what about other specific activities such as surveys, real world data collection?

Thank you for your answers!