Risk managements documents required for the market placement of a Medical Device compared with a Medicinal Product

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RISK MANAGEMENTS DOCUMENTS REQUIRED FOR THE
MARKET PLACEMENT OF A MEDICAL DEVICE COMPARED
WITH A MEDICINAL PRODUCT
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales.cro_at_pepgra.com
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Today's Discussion
In Brief
OUTLINE OF TOPICS
Introduction
Need for RMP
RMP What it Involves RMP What it Offers
RMP Outputs
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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 GVP
  module V. If more than one medicinal product is
  studied, article 14 of Regulation (EC) No
  1394/2007 provides a layout for RMP for such
  advanced therapy medicinal products (ATMP)

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Introduction
Risk is considered as an incident that might
occur at any point of time, which might eject
either its 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. Most of the projects
possess some risks and through risk management
documents/plan (RMP), some technical techniques
help in monitoring those activities. It includes
processes for risk management planning,
identification, analysis, monitoring and control.
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Need for Risk Management Documents/Plans (RMP)
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 device to
check the quality of the device and to know its
post-product development. As per Vth module of
GVP, it is necessary to document all the risk
management system which must be identified and
considered to lower the risks of medicinal
products. It is checked whether
pharmacovigilance activities are sufficient
enough or any other new necessary activities
have to be included. 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.
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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. This involves discussion on the
quality management and common aspects of the
usage of medical devices including in vitro
diagnostic devices. RMP of medicinal products
involves identification and characterization of
the safe usage of the medicinal product and it
also rectifies and quantifies the potential
adverse risks prior to the pharmacovigilance
plans. Further, Article 14(2) of Regulation (EC)
No 1394/2007 provides a layout for RMP
for advanced therapy medicinal products (ATMP).
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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 .
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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. 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 benefits various organizations
to check back or revise the yearly plans to be
implemented.
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