The New EU MDR and What You Need to Know

E.M.M.A. International
Consulting Group
Webinar Series
“The New EU MDR and What
You Need to Know”
©E.M.M.A. International Consulting Group, Inc. 1

©E.M.M.A. International Consulting Group
Webinar Overview
The European Union Medical Device Regulation (MDR)
The purpose of this webinar “The New EU MDR and WhatYou Need to Know” is to discuss the
significant changes in the medical device regulations in the EU.
There is a significant amount of work for companies marketing devices in the EU that wish to continue
to do so.The ultimate takeaway is that due to the significant implications for medical device
manufacturers, preparations must begin immediately.

About the Presenters:
3
Carmine Jabri
President/CEO
carmine.jabri@emmainternational.com
Office: 248-987-4497
Cell: 419-215-9108
Carmine Jabri, PhD, MSJ, MSQM, MHA is co-founder of
E.M.M.A. International Consulting Group, Inc., and serves as its
President and CEO. He has more than twenty years of
experience implementing, improving and directingQuality
Management Systems and Healthcare Operations. Dr. Jabri’s
career includes expertise in the Biotechnology,
Pharmaceuticals, and Medical Device industries. He is an
internationally sought-after quality systems expert.
Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a
Master of Science in Jurisprudence, a Master of Science in
Quality Management, a Master of Science in Health Services
Administration and a Bachelor of Science in Chemistry.

About the Presenters:
4
Jan Flégeau is the Director of Global Regulatory Affairs at E.M.M.A.
International. In this role, Ms. Flégeau oversees all the regulatory
affairs services that E.M.M.A. International offers. Ms. Flégeau began
working in regulatory affairs while living in Paris, France. She has
spent over 20 years in the medical device field working in diverse
international companies both small and large, focusing on a variety of
medical devices such as cardiac, orthopedics, catheters, active
implantable devices…etc. She is an expert in CE marking, FDA
submissions and international registrations. Her expertise includes
regulatory strategies, submissions, technical files and creative
problem solving. Ms. Flégeau has worked directly with regulatory
agencies in Canada, EU, China, Japan, Korea, France, and Brazil.
Ms. Flégeau holds a BA in International Business from Illinois
Wesleyan University, and a Leadership Certificate from Kellogg
School of Management. She is fluent in French. Ms. Flégeau oversees
the Florida chapter of the Regulatory Affairs Professional Society
(RAPS).
Jan Flegeau
Director of Global Regulatory Affairs
jan.flegeau@emmainternational.com

Introduction
■ Medical device manufacturers are now in a two-year transition period before full
application of the new EU MDR in 2020.
■ Do not wait, there is a significant amount of work to be completed in this relatively
short time-frame.
This Photo by Unknown Author is licensed under
CC BY-SA
■ To comply with the regulations, it is essential for
medical device manufacturers to identify which
of their products will be affected by the new
MDR requirements and plan ahead.

Introduction
■ The MDR will replace the existing Medical Device Directive (MDD) and the
Active Implantable Medical Device Directive (AIMDD) in providing
requirements and EU market access.
MDD
93/42/EEC
AIMD
90/385/EEC
MDR
2017/745

New EU MDR Triggers
Restore
confidence in
the EU
Regulatory
Process 1
Ensure that
products are
effective and
safe
Products can be
freely and fairly
traded
throughout the
EU
Communication
and
transparency
Better
functioning of
notified bodies
Several high-profile incidents triggered the need for improvement
in standards, processes and procedures and acted as catalysts for
reform.

Goals of the new EU MDR
a new and improved landscape
■ All medical devices will have to undergo an
independent assessment of safety and
performance before they can be marketed in
the EU 1
■ Clearer rules will be in place to enable
standardization and support simpler and less
complex trading between EU member states;
anyone that does not comply will be penalized
1
■ There will be greater transparency of
information on the benefits for patients,
residual risks, and a thorough assessment of
the overall risk/benefit ratio will be necessary
1

Goals of the new EU MDR
a new and improved landscape
■ The new rules support patient-oriented innovation and take particular
account of the specific needs of the many small and medium sized
manufacturers in this sector 1
■ The EU MDR will place further responsibilities on “Notified Bodies” -
those independent third parties that perform conformity assessments
for medium and high risk devices. The Notified Bodies will be subject to
heightened scrutiny from competent authorities and will need to be
designated under the EU MDR, with the process of designation
coordinated at a European level 1

Timeline
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
3 year transition period
March 2019 – Transition to
ISO 13485:2016 must be
completed.
May 2020 – MDR date of
application.
May 2022– EC
certificates of
conformity issued
before May 27, 2017
expire.
May 2024– Required for
all EC certificates issued 5
years from the
issue/renewal date or 4
years from the MDR date
of application (May 27,
2020), whichever comes
first.
May 2025– Devices certified
under the MDD can no longer
be sold or distributed
WE ARE
HERE

Industry Impact
■ All products with CE Mark will be impacted
– No grandfathering in of products
– All new launch products must go through the MDR process by May 2020
■ C-suite leadership must be educated on the changes the EU MDR will demand
– Medical device companies will be effected from a commercial, portfolio,
R&D, process, and organizational perspective.
 If the requirements are not met within the defined
timelines, it could mean withdrawing a product from
the market.

Cost of Quality
■ Cost of Compliance
– Medical device organizations may face cost of compliance in the
millions. Many organizations could be forced into assessing if there
is significant ROI for a product to be viable.
– Industry portfolios’ risk being significantly impacted, with the cost
of compliance possibly in the multi-millions.
– There may be more mergers and acquisitions due to companies
divesting products
12
This Photo by Unknown Author is
licensed under CC BY-NC-SA

Significant Impact Areas*
■ Vigilance and Post Market Surveillance
(PMS)
■ Reprocessing of single use devices
■ Supply Chain
■ Labeling
■ Reclassification
■ Technical Documentation
■ Market Access of Legacy Products
■ Clinical Evaluation
■ Mandatory Product Liability Insurance
■ Transparency
■ UDI System
■ PSUR
■ Safety and Clinical Performance
*This is not an all inclusive list

Vigilance and Post Market Surveillance
(PMS)
■ As part of their on-going assessment of potential safety risks, device
manufacturers will be required to collect post-market clinical data 2
■ Reporting timeframes are changed from 30 days to 15 days for reporting serious
incidents 2
■ Companies must review their PMS procedure to ensure that the responsibility of
providing additional support and data is clearly established
14

Summary of Safety and Clinical Performance –
Article 32 Class III and implantable devices (no custom-made or investigational devices)
15
Format/Update
• Submitted in combination with an updated CER + technical documentation summary
• Written in a language clear to the final user (potentially a lay person)
• Updated at least annually and submitted for NB validation
• Publicly available through EUDAMED and referenced in labels or IFU
• Submitted in language accepted by NB + confirmation of a certified translations
Contents
• intended purpose, including indications, contra-indications and target populations;
• suggested profile and training for users
• possible diagnostic or therapeutic alternatives
• identification of the device and the manufacturer (including UDI-DI, SRN)
• information on any residual risks and any undesirable effects, warnings and precautions
• description of the accessories, or other devices/products intended to be used in combination
• description of the device, including a reference to previous generation(s) or variants, and the description of
the differences
• summary of the clinical evaluation and relevant information on the PMCF
• reference to harmonized standards and common specifications

Periodic Safety Report Update (PSUR)
Article 86
16
Class IIa Class IIb Class III
Updated 2 years Annually Annually
NB Assessment When necessary
(in technical
documentation)
When necessary
(in technical
documentation)
At each update
(via EUDAMED)
■ The purpose of the PSUR is to present and summarize the post-market surveillance information,
analyze, and present the benefit/risk profile of the device within a defined period.
■ The post-marketing surveillance activities require volume, capacity, and capability assessment.1
■ Analysis of PMS data (results &conclusions)
■ Preventive & corrective actions
■ Risk-benefit determination
■ Main findings of PMCF
■ Volume of sales + estimate of user population + frequency of use

Reprocessing of single use devices
■ Reprocessing can only take place if permitted by the relevant National Law
– Reprocessors have the same obligations as device manufacturers
– Additional staff training may be needed
■ Prior to the MDR there was no single European standard or regulation of single-
use device (SUD) reprocessing.3
■ Key take away: Reprocessors are considered equivalent to manufacturers
17

Supply Chain
■ It will be important to understand how the current supply chain is managed,
including:
■ MDR Change- Each manufacturer is required to appoint a Person Responsible
for Regulatory Compliance (PRRC) (MDR Article 15)
■ The new regulation around medical devices will strengthen the controls around
traceability and transparency within the whole supply chain.1
18
Manufacturer Importer
Authorized
representative
Distributor

UDI System
UDI
System
MDR requires traceability of all devices
placed on EU Market
Each device will need an assigned UDI from a
UDI Supplier and this information must be
uploaded into EUDAMED
UDI requirements include product data
drawn from multiple sources
19

Labeling
■ There are significant requirements for labeling under the MDR
– Companies must consider that every label and instruction will need to be
changed in line with EU MDR.
■ Just this effort around the labeling alone will take considerable time, resource
and planning.
– For example, will there be enough space on the label for the extra
information needed? 1
■ The UDI will need to be implemented and differences between the FDA and EU
classification taken into consideration for products on the market globally. 1
20

Labeling cont.
21
DON’T FORGET
ABOUT YOUR
WEBSITE!
 Information supplied by the manufacturer needs to be
kept current on their website (MDR) Chapter III, 23.1)
 Companies should be asking how many resources will
be required to manage product label change

Reclassification
■ Companies will need to review their product lines for products that the classification
status will change or the oversight by the Notified Bodies will be heightened without
an increase in classification.4
■ It will be important to understand whether these products will need to be up-
classified in the future1,4
– Up-classified products will need more significant Notified Body review 4
22

Reclassification
■ Even though less than 10% of
medical devices will be affected by
reclassification, all manufacturers
should become thoroughly familiar
with the classification changes and
determine whether they will have
any impact on their device 4
■ the MDR introduces new
classification rules to determine the
correct class of software and devices
incorporating nanotechnology 4
23

Software Classification
■ Class III—software intended to provide information used to take decisions for
diagnostic or therapeutic purposes that has the potential to cause death or an
irreversible deterioration in health. 5
■ Class IIb—software intended to provide information used to take decisions for
diagnostic or therapeutic purposes that can cause the serious deterioration of
a person’s health or a surgical intervention. Also covers software intended to
monitor vital physiological parameters that could result in immediate danger
to a patient. 5
■ Class IIa—software intended to provide information used to take decisions for
diagnostic or therapeutic purposes or to monitor physiological processes. 5
■ Class I—all other software.5
24

Orthopedic Classification
■ Significant up-classification to class III 5
■ Classification changes are primarily a result of long-term performance
25
• All Hip, knee
and shoulder
joint
replacement
were
reclassified
from class IIb
to class III
Under a
previous
Amendment
to the MDD
The MDR adds the
following (to be
up-classified from
IIb
Joints (ankles,
elbows, toes,
fingers, etc.
Class III devices

Technical Documentation
■ The review of technical files and design
dossiers by Notified Bodies may also result in
more comments that must be addressed before
the reviews are completed.
■ Significant time needs to be accounted for by
companies to ensure that their documentation
management process enabled the technical
documentation to be organized, easily
searchable, and current throughout the device
lifecycle
26

Technical Documentation
Key changes that impact technical files
■ EUDAMED (Article 34)
■ Clinical Evaluation Plan and the Report (Annex II), increase in scrutiny and requirements (Article
61)
■ Scrutiny Procedure (Article 61)
■ Labelling in the languages accepted in member states in countries expected to be sold (Annex II)
■ Overview of previous generation of same device type and similar types of devices on the market
(Annex II)
■ Periodic Safety Reports (Annex III)
■ PMCF Plan (rationale where not required) and PMCF report (Article 84, Annex III)
■ 23 General Safety and Performance Requirements (Annex I)
■ UDI (Article 27, Annex II)
27

Technical Documentation cont.
Key changes that impact technical files
■ PMS Plan (Annex III, Annex VIII) – minimum required information included in Annex
III
■ More scrutiny on overall lifecycle of device (Annex III)
■ Subject to due diligence by all economic operators (Annex VI)
■ Regulatory Strategy for compliance to legal requirements and conformity assessment
(Annex IX)
■ Non-medical purpose products in scope (Annex XV)
■ Prescriptive format compared to MDD
■ Annex IX gives detailed requirements for QMS (addition to ISO 13485)
■ Person responsible for regulatory compliance (PRRC)
■ Document retention changed from 5 years after manufacture of last device to 10 years
after placement of market of last device (15 years for implantable (Annex IX)
28

Clinical Evaluation
Change resulting from
MDR
■ The MDR is more explicit about the
need for clinical evidence and
clinical evaluation
■ Scientific literature used for
equivalence will need to now
include more clinical trials
■ Additional clinical evidence will also
be required for products already on
the market
Planning Ahead
■ Manufacturers need to be aware of
additional scrutiny of Clinical
Evaluation Reports (CERs) by NB’s
■ Manufacturers should start to
review their CERs to ensure they
include post market surveillance
data
■ Bring in HELP if you need it
29

Mandatory Product Liability Insurance
■ Medical Device Manufacturers must be able to provide sufficient coverage for
their product Liability
30
Review your product
liability with your legal
counsel

Transparency
■ In the MDR Preamble, transparency is one of the guiding principles
“Transparency and adequate access to information, appropriately presented for
the intended user, are essential in the public interest, to protect public health, to
empower patients and healthcare professionals and to enable them to make
informed decisions, to provide a sound basis for regulatory decision-making and
to build confidence in the regulatory system.”
■ There will be greater transparency of information on the benefits for patients, residual risks,
and a thorough assessment of the overall risk/benefit ratio will be necessary
31

EUDAMED
■ The EUDAMED Database is an electronic system for incidents reporting, field
safety corrective actions, periodic summary reports, periodic safety update
reports (PSUR), and trend reports)
■ The EUDAMED database, as part of the new regulations, will be made
available at an appropriate level to the public and healthcare
practitioner (HCP) to improve transparency, enabling the public and the HCP
to make informed decisions about medical device products.1
32

EUDAMED
33
EUDAMED
Market
Surveillance
e
Vigilance
Reporting
Certification
and status
Registration/
Conformity
Assessment
Applications and
Summary of
Safety and
Performance
Clinical
Investigation
UDI

Key Takeaways
34

Make A Plan
Start Small-
Do not get
Overwhelmed
Identify Potential
Deficiencies
Determine if the
classification
changed will
effect you
No Shortcuts!
Invest theTime
and Resources

Start Small- Do not get Overwhelmed
■ As with anything breaking down what you need to do
– For example, develop a roadmap using one product in your
portfolio. Use this as your guide
■ DO NOT try to tackle everything at once
36
This Photo by Unknown Author is licensed under CC
BY-SA
PLAN AHEAD!

Identify Potential Deficiencies
■ Conduct a through analysis of your product portfolio
■ MDR is much more rigid and many devices will not have been fully
evaluated against the newest requirements
■ Most legacy devices will need updated robust clinical evaluations and
date to meet MDR requirements
■ Remember there is more pressure and accountability on Notified Bodies
to confirm manufacturers are fully compliant and devices are fully
supported by adequate data and technical documentation, therefore they
will be conducting more thorough reviews
37

Determine if the classification changed
will effect you
■ Reference slides 19-20 and 25-26
38
Conducting a thorough gap analysis will
help you to evaluate how criteria
changes will affect your product
portfolio and help guide you on where to
focus most of your time and efforts

No Shortcuts! Invest the Time and
Resources
■ Must have C-suite support
■ Shortcuts will only cost you financially
more later
■ Invest in additional help- remember
you still have your “day job”
39
This Photo by Unknown Author is licensed under CC BY-NC-ND

Contact Us
40
Farmington Hills, MI:
Headquarters
27600 Farmington Rd., Suite 100
Farmington Hills, MI 48334
Phone (248) 987-4497
Clearwater, FL:
28870 US HWY 19 North, Suite 300
Clearwater, FL 33761
Phone (727) 614-8851
York, PA:
320 Busser Road., Suite 200
Emigsville, PA 17318
Phone (717) 429-6875
Lebanon
7TH Floor, Le Mall Building,
Dbayeh Highway, Northern
Metn, Lebanon

References:
1. Hodgson, D., Maini, F., Dohrmann, M., Greenrose, W., Grover, M., and Chan, S. (2016) Preparing for the future: The
new European Union medical devices regulation [White paper]. Retrieved March 20, 2018, from Deloitte:
https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-eu-med-
device-regulation.pdf
2. Hoxey, E. (2017) Planning for implementation of the European Union Medical Devices Regulations – Are you
prepared? [White paper]. Retrieved March 12, 2018, from BSI Group:
https://www.bsigroup.com/meddev/LocalFiles/en-US/Whitepapers/bsi-md-whitepaper-implementing-eu-md-
regs.pdf
3. AMDR(2018) AMDR Participates in Upcoming EU Conferences, Promotes Reprocessing and Remanufacturing of
Single-Use Devices. Retrieved March 11. 2018: http://amdr.org/2018/01/amdr-participates-upcoming-eu-
conferences-promotes-reprocessing-remanufacturing-single-use-devices/
4. Brooks, P. (2017, June 15). 6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation.
Retrieved March 20, 2018, from https://www.raps.org/regulatory-focus™/news-articles/2017/6/6-things-you-
need-to-do-to-prepare-for-the-new-eu-medical-devices-regulation
5. Brooks, P. (2017, May 30). TIME FOR CHANGE—UNDERSTANDING THE NEW EUROPEAN MEDICAL DEVICE
REGULATIONS. Retrieved March 20, 2018, from https://www.medteceurope.com/visit/news-and-updates/time-
change-understanding-new-european-medical-device-regulations
©E.M.M.A. International Consulting Group, Inc. 41

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