Preparing for the Future: The New European Union Medical Devices Regulation

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Preparing for the Future The New European Union
Medical Devices Regulation
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales_at_pepgra.com
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Today's Discussion
OUTLINE OF TOPICS In Brief Introduction
EU-MDR Preparing for the Future Approach to
EU-MDR Conformity
In-Depth Understanding of the EU-MDR and EU-IVDR
(Step 1) Review and Evaluation of Medical
Device Portfolio (Step 2) Strategy and Roadmap
for new EU-MDR (Step 3)
Future Scope
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In Brief
For long, medical device regulations continued to
remain stagnant till such time that the world
was struck with the hip replacement and breast
implant crisis. The new EU-MDR and EU-IVDR brings
in more stringent regulations, drastically
modifying the way in which medical device
manufacturers operate. The new regulations have
also modified several device classes that were
previously quite lenient into classes that now
require strict review and evaluation. It also
takes into its ambit accessories to medical
devices that were previously unregulated.
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Introduction
Right from the early 1990s, there has hardly been
any changes in terms of regulation of the medical
device industry within Europe. Nonetheless,
owing to some incidents during the recent past,
comprising of the crisis revolving around hip
replacements and breast implants has now incited
the need for stringent compliance and regulatory
reforms within the industry. The most prominent
amongst all regulations were the European
Commissions 2012 proposal for regulation on
medical devices (EU-MDR) and in-vitro diagnostics
(EU-IVDR). In the event that medical device
manufacturers fail to conform to the changes, it
would most probably lead to the medical device
manufacturer forfeiting its manufacturing license.
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EU-MDR
The new EU-MDR 2017/745 brings legislation in EU
at par with technical developments,
modifications within medical science and
advancements in terms of law-making. Implementati
on of the new EU-MDR would eventually establish a
regulatory framework that is transparent, robust
and sustainable, which will receive global
recognition, thereby enhancing clinical safety
and facilitates manufacturers with an access to
market. The new EU-MDR would restrict any
discrepancies in terms of interpretation
throughout the EU market.
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Preparing for the Future
The European Commission has of late published
five documents with the intention of providing
guidance to manufacturers as well as other
economic operators with regards to the changes
effected through the new EU-MDR and
EU-IVDR. They said guidance related documents
comprise of implementation models as well as
factsheets for medical device manufacturers as
well as in-vitro medical device manufacturers,
along with an extensive list of requirements for
medical device manufacturers. Those
manufacturers who have not commence execution of
the new EU-MDR can refer to these guidance
documents as an initial roadmap, whereas, those
manufacturers who have already progressed with
the execution can refer to it as a
checklist. Certain devices have also been
reclassified on the basis of risk analysis while
introducing a procedure of consultation on
clinical evaluation.
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Approach to EU-MDR Conformity
Considering the intricacy and extent linked with
executing the new EU-MDR, it is imperative that
manufacturers adopt a cross-functional approach
which extends across the enterprise. Essentially
, there would be three steps to execute and
adhere to the new EU- MDR and acquiring
conformity.
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In-Depth Understanding of the EU-MDR and EU-IVDR
(Step-1)
It would be necessary that medical device
manufacturers have an enhanced understanding of
the new EU-MDR, its overall impact and scope on
their business. Several manufacturers would be
having an amalgamation of products therefore the
proposed modifications make sense. It would also
be significant to comprehend any overlap with
other pertinent directives and regulations such
as clinical trial regulation (CTR) for human use
and IVD etc.
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Review and Evaluation of Medical Device Portfolio
(Step- 2)
The entire gamut of products manufactured by a
manufacturer needs to be necessarily evaluated
and reviewed in line with the EU-MDR and
requirements of the future. For instance, as per
the new regulation those products that have been
categorized as accessories would fall under the
ambit of medical devices. There is also scope
that as per new requirements, classification
status of certain products might change. It
would be imperative to understand whether such
products need to be up-classified in future and
its corresponding impact.
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Strategy and Roadmap for new EU-MDR (Step- 3)

• Following the complete review and evaluation of
  the product portfolio as per the existing and
  future states, it would be possible to define
  gaps.
• Such gaps can be necessarily categorized as
  tactical and strategical projects, which can be
  prioritized on the basis of legal, business and
  regulatory drivers.
• To structure a regulatory strategy for affecting
  the new EU-MDR, there is a need for device
  manufacturers to define a logical sequence of
  activities.

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Future Scope
Medical devices that have not been covered under
EU-MDR such as products that are known to
utilize viable biological components for its
intended purpose should also be included under
the ambit of EU-MDR and EU-IVDR.
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