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SELECTING
THE IDEAL
PMCF
ACTIVITY
Jo n I . Be r g s t e i n s s on , SMA RT- TRIA L co - f o under
SELECTING THE IDEAL
PMCF ACTIVITY
TA BLE OF CONTE N TS
3 PMCF Plan
studies, have been limited to higher risk devices. This is largely because
many medical device manufacturers took advantage of. The MEDDEV guidance
documents are a good example of this, where some of the reasons for not to
conduct PMCF studies were largely misinterpreted by the industry and used as
an excuse to not conduct PMCF activities. Because PMCF requirements have not
been as stringent as they are now under the EU MDR, many MedTech companies
have been getting by with small or non-existing clinical operations teams. And
those companies who have more established clinical operations, are more
capture needs.
The lack of PMCF experience in combination with the lack of practical guidance
from the EU commission has led to great confusion amongst industry peers on
what activities to include in a PMCF plan for different types of medical devices.
Post-Market Clinical Follow-Up plan (or a PMCF plan) must describe general
and specific activities (or methods) that gather data on clinical performance and
safety. Until now, there has been no guidance available for manufacturers on
how to select the proper PMCF activities. This guide will supply an overview of
both generic and specific PMCF activities, and guidance on when and how to
NOTE
If you have a medical device on the market, you need to collect clinical evidence
to comply with the EU MDR. SMART-TRIAL’s Electronic Data Capture (EDC)
software will allow you to streamline your postmarket activities like PMCF
surveys, registries, studies, etc, in a compliant setting.
Read more
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SELECTING THE IDEAL PMCF ACTIVITY PAGE 3
PMCF PLAN
The EU MDR clearly states that the goal of PMCF is to continuously gather
data on both clinical performance and safety, which shall be used to update the
Post-Market Surveillance (PMS) and Clinical Evaluation Report (CER). The PMCF
It is not enough to just document which activities you will conduct, you must
also justify why and to which degree they are relevant for your PMCF plan, with
scientific reasoning.
market approval.
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General PMCF methods alone are not likely to provide sufficient data that can
the source of data is often subjective (i.e. not scientifically valid) and the quality
subjective surveys from physicians. Which is why, for most devices, you often
need to combine these activities with data from specific PMCF activities.
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Specific PMCF activities are “higher-level” operations that can produce a dataset
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All the specific activities examples we provided, are based on patient cases
where the device is being applied in practice. This produces a dataset where
The biggest pros to using specific activities is the fact that you usually gain direct
access to the raw data that’s captured, which can be difficult with more general
because the EU MDR specifies that manufacturers must be able to show clear
access to the data used for clinical evaluation or PMCF, when referring to clinical
•
Investigator Initiated Trial or Investigator Initiated Studies
•
PMCF literature search
•
PMCF Surveys, for both experience, feedback, and safety data collection
•
PMCF Cohort Survey
•
PMCF Case Series
•
PMCF Studies and PMCF Investigations – observational, comparison
•
PMCF Registry – a Private registry study managed by the manufacturer
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Each activity has its own set of pros and cons, and it’s vital to evaluate each
activity together with other factors involved before deciding on which activities to
available to gather enough data for the first PMCF report. This can highly impact
which activity you select for your PMCF plan and how long you can conduct one
observational activities. Low sales will potentially require you to initiate interven-
PMCF data needed for future activities. Depending on how much you need to
ing from that activity might not suffice the standard required to document perfor-
mance.
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SELECTING THE IDEAL PMCF ACTIVITY PAGE 11
your customers can open the doors up for data collection activities, such as
surveys.
Do they know your brand well enough for you to be able to gather survey data
directly from them? Do you have their contact information, or is that blocked
ensure that patients have provided consent to process their data, if you get
trol of clinical experts? If yes, you might not have a possibility to gather data from
pros and cons of each available PMCF data collection method before moving
forward with the PMCF plan. In the following, we have assembled the key pros
and cons for each method to simplify medical device manufacturers' decision on
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PROS CONS
Compared to many other PMCF ac- There is still one big issue with using
tivities, literature search requires less literature for clinical evaluation and
have relied on publications on similar EU MDR Annex XIV: ‘’It shall be clear-
Certain types and families of devices they are claiming equivalence in order
are more common (or popular) than to justify their claims of equivalence. “
which means that there might already In short, manufacturers need to have
be a vast amount of information avail- access to the data used for clinical
Third-Party Registries
Registries are common for high-risk devices (Class III) and long-term implantable
devices, and often contain detailed information on each case/patient. Registries
for lower class devices are also found, but these are far less common and often
only established for research purposes with funding from grants etc.
PROS CONS
Data from a third-party registry is
Registries do not exist for every
usually centered around patients or
single device in every country. The
cases, which provides a sufficient
need and requirements for these
level of traceability and detail needed
registries can be vastly different from
for PMCF.
one country to another, and the data
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Investigator initiated studies (IIS) have become increasingly more popular among
medical device manufacturers to gather clinical data. Some larger manufacturers
have dozens and even hundreds of key opinion leaders who are continuously
running clinical investigations on medical devices, which the manufacturer
somewhat sponsors. In return, manufacturers gain access to use the data for
regulatory and marketing purposes.
PROS CONS
IIS have the potential to collect vast The quality of IIS varies quite a lot.
tigator initiated, they are managed ISO 14155:2020, which is the golden
also means that much of the oper- tions with medical devices. This might
these IIS are partly sponsored by the thus increase the cost.
other resources, but much of the cost, managed by the investigator, it can
The data coming from these kinds of be as relevant for PMCF reporting as
PMCF Surveys
PMCF Surveys is a hot topic in the MedTech industry, as many medical device
manufacturers look to implement surveys in their PMCF plans to address the
PMCF MDR requirements. A survey is just one way of collecting data, and
is usually accomplished by asking a set of questions to a certain group of
individuals who share a common attribute.
Surveys can be initiated in multiple ways, with various tools, and for PMCF these
can either be directed towards end-users (like patients) or physicians. Depending
on who the recipient is, the data can either be subjective or patient-specific.
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PROS CONS
Conducting a Survey may not require No matter what kind of survey you
end-users or physicians who use the represent a valid sample of the popu-
device in practice, it can be fairly easy lation using the device in practice. This
to initiate a survey and ask a few ques- alone can be a challenge for many, as
Sending out a survey does not nec- the end-users to the manufacturer.
committees (although this differs from Even though surveying patients can
a survey does not have to take much comes and safety, this might not be rel-
time either. Thus, this can be a quick evant for all devices, which means that
and easy way to gather data for all surveying physicians is the only option.
to illustrate performance.
SELECTING THE IDEAL PMCF ACTIVITY PAGE 18
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PROS CONS
Asking patients directly about clinical
Similar to surveys, a Cohort study
outcomes and safety provides scien-
would require contact or access to
tifically valid data that can be used
patients, either directly from manufac-
for PMCF. Conducting a cohort study
turer to end-users or via healthcare
might not be as expensive as con-
experts. At the same time, a cohort
ducting an investigation, but it can still
study is also only relevant if the de-
provide a similar level of data quality
vice outcome measures are based on
(depending on the design).
patient-
reported outcomes.
If a cohort can be initiated before
PMCF Case series is a simple data collection activity that includes a series of
cases or patients. For years, device manufacturers and device sales reps have
gathered basic data from physicians (often in paper-based manner) to document
effects and use of the device across different cases. This can be used for post-
market surveillance, and for better understanding of how the device is applied in
practice.
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Now, with digital solutions becoming the golden standard for clinical data
collection for MedTech, it might become easier for manufacturers to initiate
case series to gather data for PMCF. For example, this can be done by enabling
physicians to report simple data in an ad-hoc manner on every 10 or 100 cases.
PROS CONS
When established, Case series do not For higher class devices it can prove
require much work from manufactur- difficult to setup case series data
ers and can provide a continuous and collection when long-term follow up
without much interference to stand- comes. Case series are often more
ard practice. This is also a very cheap applicable for simple datasets over
data collection.
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The biggest difference between the two, is the level of planning and regulatory
documentation needed. Manufacturers that have enough devices in use in
practice, can look to initiate observational investigations – sometimes also called
PMCF registries.
PROS CONS
By including a PMCF study in your
The data quality and control come
PMCF plan, you can be almost certain
at a cost of additional resources.
that the data quality is good enough
Furthermore, for some devices that
for the Notified Body.
require long-term follow-ups, it can
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SELECTING THE IDEAL PMCF ACTIVITY PAGE 25
There is no one activity more correct than the others. Each PMCF plan must take
all of these (and more) into account and evaluate the pros and cons together with
other factors that can impact the decision.
If you are interested in learning more, see our complete guide on how to ensure
compliant Post-Market Clinical Follow-up data collection under the EU MDR.
NOTE
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SELECTING THE IDEAL PMCF ACTIVITY PAGE 26
Imagine that you had one platform for all your clinical data
collection activities.
Imagine that you had one platform where you could gather and
manage your data for Surveys (PMCF/PMPF), Cases, or Registries.
And now imagine that this one system is also pre-validated per ISO14155:2020,
and simplifies regulatory compliance for FDA 21 CFR Part 11, GDPR, and HIPAA by
offering ready-to-use QA templates, system modules, and guidance documents.
Know that you can have this one platform, designed specifically for the needs
of the medical device industry.
‘‘We've managed to cut weeks of work out of clinical tests simply by being more ef-
ficient in the way that we collect and manage data, with additional benefits of data
being of a higher quality and error-free which will help us drive our products faster to
market.’’
Karen Elise Karlsmose Boel - Head of Clinical Audiology and Usability, SIV - Oticon A/S
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