• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product. • Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971. • For medicinal products the risk management documents/plan is achieved by • If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP) To Continue reading : https://bit.ly/3e1harA Contact us; website: https://bit.ly/2W1nV6r Email: sales.cro@pepgra.com

1. Copyright © 2020 pepgra. All rights reserved 1
Risk Managements Documents Required for the Market Placement of a
Medical Device Compared with a Medicinal Product
Dr. Nancy Agens, Head,
Technical Operations, Pepgra
Sales.cro@pepgra.com
In Brief
The necessity of the risk management
plan (RMP) has been studied before the
launch of the medical device and
medicinal product. Risk management
documents/plan for medical device is
done and verified through FDA QS
regulations and ISO 14971. For
medicinal products the risk management
documents/plan is achieved by
GVPmoduleV. If more than one
medicinal product is studied, article 14(2)
of Regulation (EC) No 1394/2007
provides a layout for RMP for such
advanced therapy medicinal products
(ATMP)
Key words: Risk management
documents/plan (RMP), Food Drug &
Administration (FDA), ISO 14971, GVP,
medical device, medicinal product.
I. INTRODUCTION
Risk is considered as an incident thatmight
occur at any point of time, which might
eject either it’s positive or negative affect
on project. Risk can occur due to many
factors taken into consideration and one
has to understand that not a single factor is
responsible for any damage. For example,
a case may need permission from
environmental department to carry out the
work, but if the man power assigned might
not be sufficient to continue the work as
the risk involved is the available personnel
may not complete the work in stipulated
time or might take longer time to issue a
permission or those documentations may
not be adequate for the activity. Such risks
show tremendous impact on the economy
of the projects which are pre planned and
scheduled to perform. However, most of
the projects possess some risks and
through risk management documents/plan
(RMP), some technical techniques help in
monitoring those activities. Hence, risk
management is necessary to implement on
all those documents whose probability of
having risk is found to be high.It includes
processes for risk management planning,
identification, analysis, monitoring and
control. Many of these processes are
updated throughout the project lifecycle as
new risks can be identified at any time. It’s
the objective of risk management to
decrease the probability and impact of
events adverse to the project.
II. THE NEED FOR RISK
MANAGEMENT DOCUMENTS/PLANS
(RMP)
Usually most of the medical devices that
are designed and medicinal products which
are prepared to reach the doctors first and
later to patients, considering that their
usage is believed to be safe on patients, but
sometimes unknowingly both doctor and
patient experience the risk either due to
device or medicine. Hence, it is essential
to understand why the risk management is
needed for both medical device and
medicinal product, one has to follow FDA
QS regulations and ISO 14971 for medical
deviceto check the quality of the device
and to know its post-product development
which would explain the risk management
process of medical device. On the other
hand, as perVth
module of GVP, it is
necessary to document all the risk
management system which must be
identified and considered to lower the risks

2. Copyright © 2020 pepgra. All rights reserved 2
of medicinal products. In addition to this,
it is checked whether pharmacovigilance
activities are sufficient enough or any
other new necessary activities have to be
included. Risk minimising activities are
mentioned or not or may have to introduce
new rules to minimize the risks. Hence, the
intention is to identify the risk involved in
usage of medical device and medicinal
products to analyse and evaluate its safety
in medicine field.
III. RMP: WHAT IT INVOLVES
At present ISO 14971-2019 was accepted
by American National Standard and was
progressed further by AAMI application of
Risk Management to Medical Devices
Working Group. This involves discussion
on the quality management and common
aspects of the usage of medical devices
including in vitro diagnostic devicesand
any harm to the humankind and its severity
in presence of ethical committee members.
They revise and review the efficiency of
the medical device every five years to
upgrade the advancement of the any
technology that might have occurred.
Although, risks are discussed, parallely the
benefits are also assessed and attention is
given on the medical device which would
be considered safe. It also estimates the
risks related to data and security systems.
Moreover, the necessity for production and
post-production activitiesmust be cleared
and revised and if necessary it should be
restructured depending on the reviews on
the safety of the medical device.
On the other hand, RMP of medicinal
products involves identification and
characterization of thesafe usage of the
medicinal product and it also rectifies and
quantifies the potential adverse risks prior
to the pharmacovigilance plans. It should
involve all the safety measures
appropriately or else it must revise for
extra safety of the medicinal product.
Further, Article 14(2) of Regulation (EC)
No 1394/2007 provides a layout for RMP
for advanced therapy medicinal products
(ATMP). It includes information if the
RMP considers more than one medicinal
product, in that situation separate
information on each medicinal product
must be mentioned along with the total
population size for each medicinal product.
Hence, analysing the risk management
plan for both medical device and medicinal
product is important before its launch.
IV. RMP: WHAT IT OFFERS
Under the jurisdiction, risk management
documents/plan is necessary to prior
analyse the risks before the medical device
is marketed. It offers protective measures
towards products (medical device and
medicinal product)against its damage. It
ensures safety of the product when used to
treat patient, and clearly provides an idea
on its adverse reactions. It also rectifies if
any device is unsafe and reaches the
market, it is immediately corrected with
efficiency.
V. RMP OUTPUTS
The output of risk management plan can
either be qualitative which grade the range
of the risk as high, medium or low and
sometimes risk score can define its risk
rank. In quantitative output, it measures or
estimates the probability of the risk
consequence.Thus, quantitative risk
estimation can resolve or focus on a
specific consequence at one particular
time.Risk management plan when
implemented on medical devices and
medicinal products, it can avoid the minute
errors in manufacturing process before it
reaches to the stakeholders. It even
benefits various organizations to check
back or revise the yearly plans to be
implemented. Most of the risks are
eliminated through RMP by applying
techniques that monitor the events that
have crucial impact and affect the outcome
of the project.

3. Copyright © 2020 pepgra. All rights reserved 2
REFERENCES
1. Risk Management Plan.
https://www.fda.gov/media/71543/download
2. ISO 14971:2019[UNKNOWN]. Medical devices —
Application of risk management to medical devices.
ICS:11.040.01. Medical equipment in general
3. Guidance on the format of the risk management plan
(RMP) in the EU – in integrated format.
EMA/164014/2018 Rev.2.0.1 accompanying GVP
Module V Rev.2 Human Medicines Evaluation. 31
October 2018.
4. Medical devices—Application of risk management
to medical devices. Association for the
Advancement of Medical Instrumentation.
Approved 10 May 2019 by American National
Standards Institute.
5. Medical devices—Application of risk management
to medical devices. ISO 14971:2019(en)