Turning compliance into competitive advantage

1. Addressing the
challenge of the
new European Union
Medical Device
Regulation
Turning compliance into
competitive advantage

2. 2 | Addressing the challenge of the new EU Medical Device Regulation
• Many organizations tend to view legislation as a driver of complexity and costs for the business.
• Where companies seek to leverage the opportunity in adoption of legislation, the outcomes for the
business can prove to be more positive:
• With the impending Medical Device Regulation (MDR) changes, cited opportunities among the
manufacturers who are early adopters include:
• Brand enhancement: Many of the changes being proposed will enhance patient safety and provide
greater assurances in product performance.
• Competitive landscape: It is likely that competitors will adopt different strategies in response to the
new legislation, based on capability to respond, including both financial and nonfinancial resources
required to undertake the potentially extensive changes. This may present market expansion
opportunities and/or acquisition targets for the business.
• As the changes are assessed, it may be concluded that some products will be unable to meet the new
regulatory criteria and/or the costs may be prohibitive.
• Portfolio rationalization: The opportunity to critically examine the product portfolio in terms of new,
current and discontinued products is based on the assessment of which products will be implicated and
to what extent they will require remediation.
• Strategic plan mitigations: Early communication to the commercial teams will enable them to revise
marketing and sales plans to address potential revenue gaps due to product withdrawals,
re-certification and supply continuity impacts.
The new medical devices legislation: a strategic opportunity for
your business?

3. Addressing the challenge of the new EU Medical Device Regulation | 3
What are the current issues and drivers for the new European
Union (EU) regulation on medical devices?
What are the current issues?
• Existing EU rules date back to the 1990s and have
not kept pace with the enormous technical and
scientific progress in the past 20 years.
• Patients, health care professionals and other parties
do not have access to essential information on
how medical devices have been assessed and what
clinical evidence there is to show they are safe and
effective. The need for greater transparency has been
highlighted by recent scandals about faulty silicone
breast implants and problems with some metal-on-
metal hip replacements.
• It is not always possible to trace back medical devices
to their suppliers. New rules on identification and
traceability of devices are needed.
• EU countries interpret and implement the current
rules in different ways.
Drivers for new regulation
• Need for greater traceability
• Need for greater transparency
• Need for updated regulation that
reflects the latest technological and
scientific advances
• Need for clarity to allow for common
understanding and implementation
among the EU countries
• Need for more robust clinical evidence
What is the new proposal?
• The EU is proposing updated regulations on medical devices — from home-use items (e.g., contact lenses,
adhesive bandages, pregnancy tests, etc.) to X-ray machines, pacemakers, breast implants, hip replacements
and HIV blood tests.
• The aim is to ensure these products are safe and can be freely and fairly traded throughout the EU.
What does it mean for medical device companies?
Timeline:
• New rules will gradually come into effect from 2016 to 2019.
• Medical devices and diagnostic (MD&D) companies will need to comply with the New Directives by the
2019 deadline.

4. 4 | Addressing the challenge of the new EU Medical Device Regulation
The new medical devices legislation is yet to be finalized; when
should your business act?
Among the manufacturers we have spoken to, it is expected that most aspects of the
proposed legislation will be adopted.
Patients
Improving patient
care, increasing
patient trust, meeting
medical need
Products
Improved quality,
removal of restricted
substances, supply
chain assurance, more
evidence of safety and
efficacy
Transparency
Move away from the
major incidents with
devices in the past,
assurance that the
products are safe,
efficacious and high
quality
Change driversPresent Near future
Current MDD
20 articles, 60 pages
• Limited clinical evidence required, general
acceptance of data from similar devices
• No regulatory authority involvement with
submission approval
• Strong data protection
• Format of technical files not defined
• Vigilance reporting timelines similar to FDA
(30 days)
• Limited traceability requirements in the
supply chain
• Basic labeling requirements
• Labeling requirement for some hazardous
substances
• Weak control of notified bodies (although this
is rapidly changing already)
Proposed MD regulation
100 articles, 200 pages
• Clinical trial data before CE marking for
implants/high risk devices, similar to FDA
• FDA PMA type approval (scrutiny process)
for high-risk/implantable devices
• Data transparency, including publication of
clinical trial data and safety summaries
• Technical files content and structure defined
in the law
• Vigilance reporting timelines possibly
reduced to 15 days
• Implementation of UDI (similar to US), EU
medical devices database, traceability
obligation
• Specified, expanded content for DFU,
required patient implant cards, medical
device statement on labels
• Possible ban or phasing out of a large
number of hazardous substances
(phthalates, boric acid)
• Very strict requirements and control over
notified bodies, small notified bodies will
likely disappear

5. Addressing the challenge of the new EU Medical Device Regulation | 5
The new medical devices legislation will have a three-year
implementation and transition window.
Page 1
Estimate timing of the new EU MDR
The Final Regulation will be a compromise between the Council, Commission
and Parliament
Transition period of only three years to
implement and validate all changes
Content of legislation can change until final adoption
Some details of the legislation will be defined after adoption in further
legal acts that will require continuation of advocacy
Commission
proposal
EU Parliament
amendments
Council position Final adoption
(estimated)
End of transition
period
EU law is
developed by
EU Commission
Sept 2012 April 2014 Q2 2015 H1 2016 H1 2019
EU Parliament
proposes
amendments
EU Council proposes
amendments
Final version of Regulation will be a
compromise between the EU Commission,
Parliament and Council version of the text
Who
When
What

6. 6 | Addressing the challenge of the new EU Medical Device Regulation
How will the proposed EU MDR
affect your business?
The new medical devices legislation key changes: how will
it impact your business and what actions can you take
to comply?
If in-vitro diagnostics are part of your portfolio, a series of parallel changes are being made to the current IVD Directive.
These changes may have a significant impact on that segment and should be reviewed with the same rigor.
Transparency
Products
Patients
EU MDR change Business implication
Revenue impact from loss in portfolio,
redesign, consider pipeline
Tighten the use of restricted substances
such as DEHP (PVC softener)
Develop and validate alternative
materials
Current pipeline considerations, revenue
impact due to increased time to market
Removal of use of equivalency claim for
clinical data on implantable and high-risk
devices
GAP assessment and update of CER with
clinical trial data where necessary for
existing and new devices
Increased time to market
EU Commission-level review of clinical
evaluation
Compile sufficient clinical trial data —
retrospective and prospective studies
Operating model impact, portfolio
changes
Substantiation of single-use claim,
comprise language likely in final text R&DDevelop single use justification
Tech files: new format and expanded
content
Labelling: expanded requirements
(patient implant cards, language specific
IFU/DFU)
Increased complexity in portfolio, supply
continuity: operating model impact
Update of all tech files
Transparency to safety records,
performance and brand positioning
Trend reporting to authorities, annual
PSURs for all devices, PMS plans
Increased vigilance reporting by patients,
HCPs, etc.
UDI, European Database (Eudamed)
New processes to be defined to cover
these challenges
Product marking
Develop database for all UDI-related data
for all devices
Potential actions
Patients
Improving patient
care, increasing
patient trust,
meeting medical
need
Products
Improved quality,
removal of restricted
substances, supply
chain assurance,
more evidence of
safety and efficacy
Transparency
Move away from the
major incidents with
devices in the past,
assurance that the
products are safe,
efficacious and high
quality

7. Addressing the challenge of the new EU Medical Device Regulation | 7
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you currently have
in view of regulatory requirements?
Where are the key business impacts?
We have tools that help you to quickly
analyze the current state across the
portfolio and identify issues and gaps.
3
How do you conduct the
change across the
business?
4
We work with you to define
how to get to the “end-game,”
based on the balance between
cost and business capabilities
to meet future legislation
timelines.
Using our methodologies and previous experience, we help
you implement a compliant solution, including changes to
people, process, data and technology. We assist you in
working alongside partners to achieve a smooth
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
you leverage your investment
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Design
Diagnose
Our approach to tackle this
complex matter
Enabling rapid response to changes in regulatory requirements
Our seven-step approach to compliance change
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you currently have
in view of regulatory requirements?
Where are the key business impact
We have tools that help you to quickly
analyze the current state across the
portfolio and identify issues and gaps.
3
How do you conduct the
change across the
business?
4
We work with you to define
how to get to the “end-game,”
based on the balance between
cost and business capabilities
to meet future legislation
timelines.
Using our methodologies and previous experience, we he
you implement a compliant solution, including changes t
people, process, data and technology. We assist you in
working alongside partners to achieve a smooth
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
Can you leverage your investment
to improve your current business
insight?
We advise you how to make better
business decisions and gain
competitive intelligence based on the
changes.
7
What is required to stay up to
date with the changing
regulatory landscape?
2
We have invested in tracking and
understanding the changes to the
regulatory landscape to provide you
access to the latest information.
Do your enterprise-wide
business projects in
compliance need managing?
1
We put in place a program
infrastructure that manages cross
functional dependencies, creates
executive visibility and
proactively identifies risks, while
managing the change impacts of
the program.
Identify
Design
Diagnose
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you currently have
in view of regulatory requirements?
Where are the key business impacts?
We have tools that help you to quickly
analyze the current state across the
portfolio and identify issues and gaps.
3
How do you conduct the
change across the
business?
4
We work with you to define
how to get to the “end-game,”
based on the balance between
cost and business capabilities
to meet future legislation
timelines.
Using our methodologies and previous experience, we help
you implement a compliant solution, including changes to
people, process, data and technology. We assist you in
working alongside partners to achieve a smooth
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
Can you leverage your investment
to improve your current business
insight?
We advise you how to make better
business decisions and gain
competitive intelligence based on the
changes.
7
What is required to stay up to
date with the changing
regulatory landscape?
2
We have invested in tracking and
understanding the changes to the
regulatory landscape to provide you
access to the latest information.
Do your enterprise-wide
business projects in
compliance need managing?
1
We put in place a program
infrastructure that manages cross
functional dependencies, creates
executive visibility and
proactively identifies risks, while
managing the change impacts of
the program.
Identify
Design
Diagnose
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you currently have
in view of regulatory requirements?
Where are the key business impacts?
We have tools that help you to quickly
analyze the current state across the
portfolio and identify issues and gaps.
3
How do you conduct the
change across the
business?
4
We work with you to define
how to get to the “end-game,”
based on the balance between
cost and business capabilities
to meet future legislation
timelines.
Using our methodologies and previous experience, we help
you implement a compliant solution, including changes to
people, process, data and technology. We assist you in
working alongside partners to achieve a smooth
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
everage your investment
e your current business
u how to make better
isions and gain
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enterprise-wide
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ace a program
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dentifies risks, while
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.
Identify
Design
Diagnose
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you currently have
in view of regulatory requirements?
Where are the key business impacts?
We have tools that help you to quickly
analyze the current state across the
portfolio and identify issues and gaps.
3
How do you conduct the
change across the
business?
4
We work with you to define
how to get to the “end-game,”
based on the balance between
cost and business capabilities
to meet future legislation
timelines.
Using our methodologies and previous experience, we help
you implement a compliant solution, including changes to
people, process, data and technology. We assist you in
working alongside partners to achieve a smooth
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
n you leverage your investment
improve your current business
ight?
dvise you how to make better
ess decisions and gain
etitive intelligence based on the
ges.
hat is required to stay up to
ate with the changing
egulatory landscape?
ave invested in tracking and
rstanding the changes to the
latory landscape to provide you
ss to the latest information.
Do your enterprise-wide
business projects in
compliance need managing?
ut in place a program
structure that manages cross
tional dependencies, creates
utive visibility and
ctively identifies risks, while
aging the change impacts of
program.
Identify
Design
Diagnose
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you current
in view of regulatory req
Where are the key busin
We have tools that help you
analyze the current state ac
portfolio and identify issues
3
How do you conduct
change across the
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4
We work with you to de
how to get to the “end-g
based on the balance be
cost and business capab
to meet future legislatio
timelines.
Using our methodologies and previous experie
you implement a compliant solution, including
people, process, data and technology. We ass
working alongside partners to achieve a smoo
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
leverage your investment
ove your current business
you how to make better
ecisions and gain
e intelligence based on the
required to stay up to
th the changing
tory landscape?
nvested in tracking and
ding the changes to the
landscape to provide you
the latest information.
ur enterprise-wide
ess projects in
iance need managing?
place a program
ture that manages cross
dependencies, creates
visibility and
y identifies risks, while
the change impacts of
am.
Identify
Design
Diagnose
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you currently have
in view of regulatory requiremen
Where are the key business impa
We have tools that help you to quick
analyze the current state across the
portfolio and identify issues and gap
3
How do you conduct the
change across the
business?
4
We work with you to define
how to get to the “end-game,”
based on the balance between
cost and business capabilities
to meet future legislation
timelines.
Using our methodologies and previous experience, we
you implement a compliant solution, including change
people, process, data and technology. We assist you i
working alongside partners to achieve a smooth
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
Can you leverage your investment
to improve your current business
insight?
We advise you how to make better
business decisions and gain
competitive intelligence based on the
changes.
7
What is required to stay up to
date with the changing
regulatory landscape?
2
We have invested in tracking and
understanding the changes to the
regulatory landscape to provide you
access to the latest information.
Do your enterprise-wide
business projects in
compliance need managing?
1
We put in place a program
infrastructure that manages cross
functional dependencies, creates
executive visibility and
proactively identifies risks, while
managing the change impacts of
the program.
Identify
Design
Diagnose
EPMO
Regulatory
requirement
assessment
Gap analysis
Implementation
plan
Sustainability
Implementation
Validate,
report and
compliance
Are you sure your
changes are compliant?
You need to design a solution tailor-made
to your needs and implement it.
Our seven-step approach to compliance change
5
6
What gap do you curren
in view of regulatory re
Where are the key busin
We have tools that help yo
analyze the current state a
portfolio and identify issue
3
How do you conduct
change across the
business?
4
We work with you to de
how to get to the “end-
based on the balance b
cost and business capa
to meet future legislati
timelines.
Using our methodologies and previous exper
you implement a compliant solution, includin
people, process, data and technology. We as
working alongside partners to achieve a smo
implementation.
We verify the changes as part of post-
project sign-off and/or as part of a
regular independent review.
Can you leverage your investment
to improve your current business
insight?
We advise you how to make better
business decisions and gain
competitive intelligence based on the
changes.
7
What is required to stay up to
date with the changing
regulatory landscape?
2
We have invested in tracking and
understanding the changes to the
regulatory landscape to provide you
access to the latest information.
Do your enterprise-wide
business projects in
compliance need managing?
1
We put in place a program
infrastructure that manages cross
functional dependencies, creates
executive visibility and
proactively identifies risks, while
managing the change impacts of
the program.
Identify
Design
Diagnose

8. Our approach: the EY — YourEncore team
We team with our alliance partner, YourEncore, to bring global breadth, relevant industry
experience and deep technical skills to the program.
EY | Assurance | Tax | Transactions | Advisory
About EY
EY is a global leader in assurance, tax, transaction and advisory services.
The insights and quality services we deliver help build trust and confidence
in the capital markets and in economies the world over. We develop
outstanding leaders who team to deliver on our promises to all of our
stakeholders. In so doing, we play a critical role in building a better working
world for our people, for our clients and for our communities.
EY refers to the global organization and/or one or more of the member firms
of Ernst & Young Global Limited, each of which is a separate legal entity.
Ernst & Young Global Limited, a UK company limited by guarantee, does not
provide services to clients.
For more information about our organization, please visit ey.com.
ey.com
© 2015 Ernst & Young LLP
All rights reserved
1510-1736890
Contact
Lucien De Busscher
Principal — EY Advisory Life Sciences
+32 (0)478 883 069
lucien.de.busscher@be.ey.com
Jon L. Lange
Principal — Ernst & Young LLP (US)
+1 215 448 5904
jon.lange@ey.com
Mark Diamond
Life Science Consulting
+1 215 272 2395
mark.diamond@yourencore.com
Eithne Lee
Associate Partner — Advisory Life Sciences
+44 121 535 2022
elee@uk.ey.com
YourEncore | Life Science | Consumer | Food
About YourEncore
Specializing in experts with an average of 25 years of industry experience
across regulatory, quality, drug safety, medical affairs and clinical
development, YourEncore helps clients manage risk and then, out-think, out-
pace and out-perform the competition.
Whether you need an immediate consultation with a technical expert, the
wisdom of an executive-level strategist or a team on the ground tomorrow,
YourEncore provides the right expertise, when and where you need it.
YourEncore Inc.
© 2015 YourEncore Inc.
All Rights Reserved.
yourencore.com
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