E B OOK

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

1 What Is This PMCF Activities Guide About?

3 PMCF Plan

4 General PMCF Activities

6 Specific PMCF Activities

8 Overview of PMCF Activities

12 Pros and Cons of Each PMCF Activity

23 PMCF Studies and PMCF Investigations (including PMCF Registries)

25 Selecting The Appropriate PMCF Activity

SELECTING THE IDEAL PMCF ACTIVITY PAGE 1

WHAT IS THIS PMCF

ACTIVITIES GUIDE ABOUT?
Before the EU MDR, the number of proactive PMCF activities, such as PMCF

studies, have been limited to higher risk devices. This is largely because

existing EU medical device regulations and guidelines had loopholes which

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

used to conducting traditional clinical investigations with traditional clinical data

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

include them in your PMCF plan.

SELECTING THE IDEAL PMCF ACTIVITY PAGE 2

The main message that I want you to take home from

reading this guide is this:

YOU CANNOT JUST COLLECT ANY DATA.

START AT THE END AND CONSIDER
FIRST WHICH RESULTS YOU WANT
TO PRESENT IN YOUR REPORT. THEN,
SELECT WHICH ACTIVITIES WILL
SUPPORT YOUR DESIRED END-RESULTS.

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

clinical experience data on your device. Specifically, manufacturers must 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

plan is the recipe for how you intend to achieve this.

I N THE PM CF PLA N, YOU N E E D TO

DO C U M ENT BOTH G E N E RAL AN D S P E C IFIC
P MCF M ETHOD S TO C OLLE C T T H IS
I NF ORM ATION.

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.

We’ll start by looking at general PMCF activities.

SELECTING THE IDEAL PMCF ACTIVITY PAGE 4

GENERAL PMCF ACTIVITIES

General PMCF activities are information-gathering operations that often produce

a subjective dataset, which cannot be used alone to scientifically document

safety and clinical performance, to a level which is acceptable for continued

market approval.

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 5

General PMCF methods alone are not likely to provide sufficient data that can

live up to standards needed to illustrate performance or safety. This is because

the source of data is often subjective (i.e. not scientifically valid) and the quality

of data can highly vary from one source to another.

For example, it can be difficult to document clinical performance based on

subjective surveys from physicians. Which is why, for most devices, you often

need to combine these activities with data from specific PMCF activities.
SELECTING THE IDEAL PMCF ACTIVITY PAGE 6

SPECIFIC PMCF ACTIVITIES

Specific PMCF activities are “higher-level” operations that can produce a dataset

which can be used to scientifically illustrate safety and clinical performance,

often based on case-specific data.

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 7

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

scientific methods can be applied to document clinical performance and safety,

to a standard that is accepted by the industry and clinical practice.

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

activities; such as with screening of scientific literature. This is important to note,

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

or safety data from equivalent devices. (Annex XIV)

‘‘I T SHA LL BE CLEARLY D E MON ST RAT E D

TH AT M ANU FACTU RE RS H AVE S U FFIC IE N T
L E VELS OF ACCESS TO T H E DATA RE LAT IN G
TO DEVICES WITH W H IC H T H E Y ARE C LAIMIN G
EQ U IVA LENCE IN O RD E R TO JU ST IFY T H E IR
CL AIM S OF EQU IVA LE N C E .’’
SELECTING THE IDEAL PMCF ACTIVITY PAGE 8

OVERVIEW OF PMCF ACTIVITIES

Some of the most common activities seen to date are:

• 
Public/global PMCF Registries

• 
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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SELECTING THE IDEAL PMCF ACTIVITY PAGE 9

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

include in your PMCF plan.

These factors include:

1. Medical Device classification and PMS reporting requirements
2. Sales numbers and markets
3. Data available from earlier Clinical Evaluations (gap analysis)
4. Device performance measure and clinical/industry standards
within the domain of interest
5. Whether you have access to customers
6. Whether you have access to end-users
7. Whether you have access to the patients
8. How the device is used/applied in practice
9. Whether there’s a data consent in place (from existing data
sources)

1. MEDICAL DEVICE CLASSIFICATION AND REPORTING

REQUIREMENTS
Depending on the medical device class there might be shorter or longer time

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

to produce sufficient data.

SELECTING THE IDEAL PMCF ACTIVITY PAGE 10

2. SALES NUMBERS AND MARKETS

If your sales are not high enough, it can be difficult to collect enough data from

observational activities. Low sales will potentially require you to initiate interven-

tional studies of some sort.

3. DATA AVAILABLE FROM EARLIER CLINICAL EVALUATIONS

Quality data from earlier clinical evaluations is the best indicator for the level of

PMCF data needed for future activities. Depending on how much you need to

‘‘bridge’’ in terms of safety or performance, will impact the choice of selecting a

PMCF activity for your PMCF plan.

4. DEVICE PERFORMANCE MEASURE AND CLINICAL/INDUS-

TRY STANDARDS WITHIN THE DOMAIN OF INTEREST
How is your device’s clinical performance measured? What data is required and
from whom? Some activities might not fit your device, because the data originat-

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

5. WHETHER YOU HAVE ACCESS TO CUSTOMERS

Do you know your customers well enough, and can you contact them directly

for feedback and information? Or even collaboration? Having direct access to

your customers can open the doors up for data collection activities, such as

surveys.

5. WHETHER YOU HAVE ACCESS TO END-USERS

Do you know your end-users well enough to be able to contact them directly?

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

behind a distributor? If your answer to these questions is no, it might be diffi-

cult to gather survey-based data.

6. WHETHER YOU HAVE ACCESS TO PATIENTS

Do you have consent to access data, or access to contact patients directly for

patient-reported outcomes or feedback? Having data processing consents

in place from patients already, is crucial to ensure compliance. You need to

ensure that patients have provided consent to process their data, if you get

access to a public data registry.

SELECTING THE IDEAL PMCF ACTIVITY PAGE 12

7. HOW THE DEVICE IS USED/APPLIED IN PRACTICE

How is your device applied in practice? Does it always require intervention/con-

trol of clinical experts? If yes, you might not have a possibility to gather data from

others than patients.

8. WHETHER THERE’S A DATA CONSENT IN PLACE (FROM

EXISTING DATA SOURCES)
For those existing registries or data sources that contain relevant data for PMCF,

do you have applicable consents in place to gain access to these databases?

PROS AND CONS OF EACH PMCF

ACTIVITY

In combination with the deciding factors above, it is important to consider the

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

which PMCF activity to use.

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 13

Literature And Published Research

Literature and research publications are still a valid method of gathering

information on clinical performance and safety. Even though the EU MDR
might have drastically changed the way we approach clinical evaluation, there
is nothing in the regulation that states that references to the literature and
published material on devices cannot be used for PMCF.

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

resources and is simple to complete. PMCF, especially when referring to

This is also why many manufacturers equivalent devices. As stated in the

have relied on publications on similar EU MDR Annex XIV: ‘’It shall be clear-

devices (equivalent devices) for clini- ly demonstrated that manufacturers

cal evaluation. have sufficient levels of access to the

data relating to devices with which

Certain types and families of devices they are claiming equivalence in order

are more common (or popular) than to justify their claims of equivalence. “

others when it comes to research,

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

able on safety and performance on evaluation reporting - which also

equivalent devices in the literature. includes PMCF. This can be difficult to

demonstrate without having contracts

in place with the authors of publica-

tions or other manufacturers.

SELECTING THE IDEAL PMCF ACTIVITY PAGE 14

Third-Party Registries

Third-party registries are databases that private/public organizations, institutions

or governmental bodies have established for various reasons. Some of these
registries contain valuable information on the application and clinical outcomes
of medical devices in practice.

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

quality can equally vary. Some regis-

The fact that datasets are already
tries might be held to a high standard
available means that manufacturers
while others are updated less fre-
will not have to initiate new activities
quently. The data in these registries
to collect the same data. Using reg-
might be relevant but may not con-
istries can be less expensive than
tain the exact attributes needed to
initiating new and private device
document/demonstrate clinical per-
registries.
formance for a given device.

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 15

Lastly, GDPR data processing con-

sents collected from data subjects in

these registries might lack the neces-

sary legal grounds to allow manufac-

turers to access the data.

Investigator Initiated Studies and Trials

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.

Learn how to use investigator initiated studies to generate MDR compliant

data here.

PROS CONS
IIS have the potential to collect vast The quality of IIS varies quite a lot.

amount of subject-specific data and It can be difficult to ensure that IIS

outcomes. Because they are inves- are following standards, such as

tigator initiated, they are managed ISO 14155:2020, which is the golden

in full by the investigator staff, which standard for conducting investiga-

also means that much of the oper- tions with medical devices. This might

ational expense is covered by the require more resources from the

investigator site and team. Some of manufacturer than anticipated, and

SELECTING THE IDEAL PMCF ACTIVITY PAGE 16

these IIS are partly sponsored by the thus increase the cost.

manufacturer, by providing devices or At the same time, because the IIS is

other resources, but much of the cost, managed by the investigator, it can

planning and management is covered be difficult to influence the research

by the investigator. goal and type of data collected. As

such, the data collected might not

The data coming from these kinds of be as relevant for PMCF reporting as

studies can be highly valuable, and needed.

the cost-benefit of conducting inves-

tigator initiated studies for regulatory

activities can be highly positive.

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.

Learn how to design a succestul PMCF survey here.

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 17

PROS CONS
Conducting a Survey may not require No matter what kind of survey you

as many resources as a clinical investi- plan to initiate, it will require access to

gation or IIS. By having access to either end-users (physicians or patients) who

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

tions on performance or safety. devices are often sold through distribu-

tors who cannot provide information on

Sending out a survey does not nec- the end-users to the manufacturer.

essarily require approvals from ethics

committees (although this differs from Even though surveying patients can

country to country) and responding to provide valuable information on out-

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.

parties. It can be difficult to structure a survey

to request subject-specific data from

physicians without it becoming subjec-

tive. When a physician is answering a

survey, questions are usually generic

and do not refer to a specific case.

Thus, results from a survey like that will

not provide scientifically valid datasets

to illustrate performance.
SELECTING THE IDEAL PMCF ACTIVITY PAGE 18

SMART-TRIAL Survey was engineered to simplify PMCF surveys for medical

device manufacturers. The goal was to make PMCF Surveys under MDR a viable
PMCF data collection method for any type of medical device. Read more about
SMART-TRIAL Survey here.

Survey Questions Example in SMART-TRIAL

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 19

PMCF Cohort Study

A PMCF Cohort Study or Survey is a data collection activity minded primarily

towards patients. This kind of activity is usually completed over 2 or more time
points, where data is collected from patients in an observational manner (e.g., via
surveys and questionnaires).

Sites Overview Panel in SMART-TRIAL

SELECTING THE IDEAL PMCF ACTIVITY PAGE 20

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

and after receiving a device, this can

If performance is not based on pa-
provide even better evidence on both
tient-reported outcomes, a cohort
safety and performance, instead of
study might be deemed irrelevant for
only asking patients who have been
PMCF.
using the device before.

PMCF Case Series

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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SELECTING THE IDEAL PMCF ACTIVITY PAGE 21

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

valid source of patient specific data, is needed on detailed clinical out-

without much interference to stand- comes. Case series are often more
ard practice. This is also a very cheap applicable for simple datasets over

alternative to investigations. short periods of time.

In addition, this requires access to

physicians and other key opinion

leaders, as well as motivational in-

centives designed to drive continued

data collection.
SELECTING THE IDEAL PMCF ACTIVITY PAGE 22

SMART-TRIAL Cases was specifically designed for this purpose, to

replace old-fashioned paper-based case-series forms with a GCP
compliant digital solution.

Automatic User Identification in

SMART-TRIAL Cases

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 23

PMCF STUDIES AND PMCF

INVESTIGATIONS (INCLUDING
PMCF REGISTRIES)

PMCF studies or post-market investigations (both observational and

interventional) are still some of the most popular sources of data when it comes
to PMCF. PMCF studies can be of different types and depending on different
factors mentioned above (such as previous gap analysis, sales numbers and
more). These can be either of observational or interventional nature.

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

take years to gather sufficient data on

On top of that, you can be in full con-
performance and safety, to be able to
trol of what data is collected and how
use the data from a PMCF study for
you would like to use it.
PMCF reporting.

Until then, PMCF reports should be

supported with other activities.

SELECTING THE IDEAL PMCF ACTIVITY PAGE 24

SMART-TRIAL Suite is the ideal data collection tool when running

a PMCF study or investigation. This enables seamless integration of
eCRF and ePRO, which streamlines and simplifies the entire study
design. Read more about SMART-TRIAL Suite here.

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SELECTING THE IDEAL PMCF ACTIVITY PAGE 25

SELECTING THE APPROPRIATE

PMCF ACTIVITY

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.

KNOWING THE AVAILABLE PMCF

ACTIVITIES AS WELL AS WHICH DATA
COLLECTION TOOL IS BEST SUITED FOR
EACH ACTIVITY, IS VERY HELPFUL IN
THE PMCF PLANNING PROCESS.

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

To get a better understanding of the digital data collection tools that

SMART-TRIAL offers for PMCF, you should take a look at our services overview.

Read more
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.

Demo SMART-TRIAL’s EDC Platform

‘‘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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EVIDENCE YOU NEED.
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TO TRUE QUALITY DATA.

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