EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

EU MDR Preparation
OMTEC
Mike Wolf CBA, CQA, RAC
Chicago, IL 13 June 2018
©2018 Maetrics. All Rights Reserved. ® Trademark of
Theoris Group, Inc. 2

What is the new EU MDR?
 Most significant regulatory change in Europe in over 20 years!
 Compliance to the EU MDR required to gain and retain CE Mark
 80+ delegating or implementing acts to come
 Notified Bodies to be re-designated
 Focus on Clinical Evidence and Post Market Clinical Follow-Up and Surveillance
 Scrutiny and review of high risk devices
 Improved transparency between NBs, CAs, Mfgs, and Users (UDI and EUDAMED)
The new European Union Medical Device Regulation (EU MDR)
AIMD
17 Articles
35 Pages
9 Annexes
MDD
20 Articles
60 Pages
12 Annexes
Directives Regulation
MDR
123 Articles
178 Pages
17 Annexes

Key Players - MDR
EU National
Competent Authorities
Notified Bodies
Reviews Testing Auditing
Clinical
Evaluations
Records
Data
QMS
Certificate
CE
Mark
Medical Device
Coordination Group
(MDCG)
Expert Panels
Suppliers
Importer
Distributors
Medical
Devices
with UDI Authorized
Representative
Manufacturer
Public
EUDAMED
= Economic Operator
PMS/PMCF
Reporting
= New or Changed Element
MDR
Person Responsible
for Regulatory
Compliance

Timelines – how long do we have?
Transition Timeline
2017 [May 25]
EU MDR
Entered into Force
2017 [Nov 25]
Notified Bodies
apply for MDR
Designation
2020 [May 25]
Notified Bodies stop issuing
MDD Certs
2017 2018 2019 2020 2024
2020 [May 26]
New or Renewing Devices
must have MDR certs
MDD Certs Issued Existing MDD Certs Valid
May 26, 2020
Date of Application
May 26, 2024
Any Remaining MDD
Certs Voided
May 26, 2025
No further placing
MDD-certified
products on the market
MDR Certs Issued

6
Timeline Convergence – Competing Transitions
ISO 13485:2016
Both ISO 13485:2003 or
2016 Certifications
New ISO 13485:2003
Certifications Discouraged
No 13485:2003 Certifications or
Re-Certifications Allowed
01 Mar 2016 01 Mar 2017 01 Mar 2018 01 Mar 2019
MDSAP
01 Jan 2016 01 Jan 2017 01 Jan 2018 01 Jan 2019
MDSAP Audit Certified
Mandatory by Health Canada
EU MDR
26 May 2020
Present Day
New or Renewing Devices
must have MDR certificates
Theoris Group, Inc.

Important for orthopedic device manufacturers
Revised device classification rules
Extended process of conformance assessment by NB and MDCG
Increased scrutiny of technical documentation - Class III and Implantable
New labeling requirements
Restriction of hazardous substances
Risks associated with interaction between software and the IT environment within
which it operates
Conformance with harmonized standards
 And Common Specifications yet to be published – 26 May 2020
Clinical evaluation and adequate clinical data
Particular Requirements for Active Implantable Medical Devices
 Devices and their component parts shall be identifiable
 Shall bear a code by which the device and manufacturer can be unequivocally identified

Significant Change – Legacy Products
CHANGE
 There is no provision for
grandfathering certification
(CE marks) obtained under the
previous Directives
 All products have to be CE
marked under the new
Regulation 2017/745, in order
to be placed on the market or
put into service (MDR Article
5), after the transition period
Market Access of Legacy Products
IMPLICATION FOR MANUFACTURER
A comprehensive plan needs to be put in place to
ensure that all products that will be maintained on the
EU market are CE marked in accordance with the full
requirements of the new MDR. This should include
products currently under development. This review
may provide an opportunity for rationalization of the
product portfolio and elimination of any marginal
products.

Significant Change - Reclassification
CHANGE
 Certain products have received
special consideration in the MDR
and are subject to reclassification.
(MDR Article 4)
 These new provisions variously
apply to cosmetic implants,
standalone software, products
without an intended medical
purpose (MDR Annex XVI), certain
spine products and reusable Class 1
devices
Reclassification of Devices
Manufacturers of medical devices should carefully
examine the MDR Classification rules in Annex VIII to
determine whether new conformity assessment
routes are now applicable to their product portfolio. If
so, they should engage their Notified Body (where
necessary) and take steps to evaluate the necessary
timescales involved in implementing this change. In
some cases, where reclassification has occurred, this
may be the first time that such relationships and
agreements with Notified Bodies have been required.

Significant Change - Reclassification
CHANGE
 Changes in the classification rules of
medical devices might lead to
reclassification of certain medical devices
 Rules organized by
‒ Non-Invasive Devices (Rules 1 – 4)
‒ Invasive Devices (Rules 5 – 8)
‒ Active Devices (Rules 9 – 13)
‒ Special Rules (Rules 14 – 22)
 There is a process to handle classifications
disputes
‒ Steps depend on if Manufacturer and notified
body are in the same EU Member State
‒ May involve consultation with competent
authority of the member state
Check new classification rules
Classification Change Examples
• In vitro contact with cells/embryos going back into
the body to be Class III (or IIa)
• Apheresis devices to be Class III
• IVF and ART non-invasive devices can be IIb
• Spinal implants to be Class III
• Total and partial joint replacements to be Class III
• Devices recording diagnostic images to be IIa
• Nanomaterial devices to be Class III
• AIMD accessories to be Class III
• Devices which are intended to be introduced into
the human body via a body orifice, or applied on
skin and that are absorbed by or locally dispersed in
the human body are to be Class III
• Reusable surgical Instruments are no longer class I

Significant Change – General Safety & Performance Requirements
CHANGE
The spirit of the “Essential
Requirements” has not changed,
however there are new provisions
and more details required (Annex I),
for example:
 Hazardous substances
 Devices with non-viable human cells
or tissues, and other “non-viable
biological substances”
 IT security and prevention of
unauthorized access
 Risk Management
 Labeling
 Alignment with Global Harmonization
Task Force (GHTF)
Manufacturers need to review and update
technical documentation in preparation for a
complete conformity assessment against
requirements of GSPR. Evidence of
conformance with each GSPR should be
critically assessed. Emphasis on improved risk
management and risk controls will also need to
be incorporated in practices and processes.
Some new requirements – others just more detailed

Significant Change – Technical Documentation
CHANGE
The MDR is significantly more prescriptive about the required content of technical documentation
(Technical File/Design Dossier):
 Essential Requirements (ERs) are replaced by “General Safety Requirements (Annex I) and
the number of requirements has been expanded
 A Presumption of conformity still applies for devices that are in conformity with relevant
harmonised standards (Article 8), but the Commission may define Common Specifications
where no harmonized standards exist or where they are considered insufficient
Additionally, there are more detailed requirements for the Quality Management Systems (QMS)
(Annex IX)
 EN ISO 13485:2016 was re-written and issued in 2016 with the new MDR very much in mind
 It should be noted that while EN ISO 13485:2016 is not an absolute requirement there will be a
general expectation that this standard will be used
Technical Documentation

Significant Change – Technical Documentation
 Technical Documents shall include:
 Device description and specification
 Reference to previous and similar generations of device
 Labels & IFUs
 Design and Manufacturing information
 Demonstration of conformance to General Safety and Performance Requirements
 Benefit-Risk analysis and Risk Management
 Product verification and validation
 Additional Requirements for Technical Documents on Post Market Surveillance
 Post Market Surveillance Plan, per Article 84
 Periodic Safety Update Report, per Article 86
 Post Market Surveillance Report, per Article 85
Detailed Requirements for Technical Documents

Significant Change – Vigilance and PMS
CHANGE
 Under the new Regulation 2017/745,
device manufacturers will be required
to collect post-market clinical data as
part of their on-going assessment of
potential safety risks
 Post Market Clinical Follow up (PMCF) is
a continuous process with the objective
of constantly updating the clinical
evaluation (Annex XIV, Part B)
 Additionally, reporting timeframes are
tightened from 30 days to 15 days for
reporting serious incidents (Article 87)
Vigilance and Post Market Surveillance
Manufacturers need to review their procedures
for PMS and ensure that the responsibility for
the provision of this additional data and
associated support is clearly established. This is
likely to require additional resources in
functions that support products on the market
such as Regulatory and Medical Affairs.
 There will be new electronic vigilance
reporting (Article 92) and Periodic Safety
Update Reports (PSUR) for all devices (Article
86) subject to differing frequency and
submission requirements

Significant Change – Vigilance and PMS
Summary of safety and clinical performance
 Draft is part of submission to notified
body for conformity assessment
 Is validated by the notified body
 After validation, is uploaded to EUDAMED
Two new deliverables required by the EU MDR
Periodic safety update report (PSUR)
 Throughout the lifetime of the device
concerned, the PSUR shall set out
‒ Conclusions of the benefit-risk
determination
‒ Main findings of the PMCF
‒ Volume of sales of the device and
estimated evaluation of the size and other
characteristics of the population using
device, and where practicable, the usage
frequency

Significant Change – Clinical Evaluations
CHANGE
 The MDR is more specific about
the need for clinical evidence
and clinical evaluation,
proportionate with the risk
associated with a given device
(Annex XIV, Part A)
 Reliance on the scientific
literature to demonstrate
equivalence will be more tightly
regulated, and clinical
evaluations will be more closely
aligned with clinical trials
associated with medicinal
products
Clinical Evidence and Clinical Evaluations
This may require manufacturers to obtain additional
clinical data from clinical studies. There will be
additional scrutiny of Clinical Evaluation Reports
(CERs) by Notified Bodies as outlined by new
guidance (MEDDEV 2.7.1 rev. 4). CERs that previously
were of a suitable level and standard and accepted
by Notified Bodies, may no longer be accepted.
Manufacturers should plan to review all of their CERs
if not reviewed within the last 1-2 years and ensure
that CERs include Post Market Surveillance data;
especially where devices are new to market and
where clinical data was limited at the time of first CE
Marking.

Significant Change – Labeling
CHANGE
Requirements for product labeling are
more prescriptive
 For example, information supplied
by the manufacturer shall be
made available and kept up to
date on the manufacturer’s
website (Chapter III, 23.1)
Manufacturers should carefully review the adequacy of
their product labelling and precautionary statements and
consider how this will be reflected on their websites.
There are requirements for
 Specific details for labels and for sterile packages (Annex I).
 Inclusion of information on residual risks for vulnerable patient
groups (e.g. children, pregnant or nursing women) and, if
applicable, on appropriate precautionary measures in the
instructions for use.
 Hazardous Substances
All EU labeling and IFU’s likely to be impacted

18
Significant Change - EUDAMED
What is EUDAMED?
Theoris Group, Inc.
• SU
 EUDAMED is a central European databank that will be accessible to notified bodies,
economic operators, sponsors, and to the public to the extent specified
 It will include protections for personal data
 What’s driving EUDAMED?
 Article 14a (MDD 93/42/EEC)
 Clinical investigations
 Vigilance and incident reporting
 Status of conformity on issued certificates
 Registration of manufacturers and EUAR

Technical Docs to MDR Certification Timeline
Many factors impact the timeline for transition of existing product submissions
MDCG Consultation for Class III &
Implantable Devices Only
Technical Documentation Updates for MDR likely to include:
• Design Requirements traced to new Safety and Performance Requirements
• Risk Management File/Report
• Clinical Evaluation Plan/Report
• Gaps in Clinical Evidence
• Any equivalence to competitive device data replaced with company’s own data
• Post Market Surveillance Reporting
• PMS/PMCF Plan/Report, PSUR/SSCP Reports (when needed + translations)
• Labeling +UDI + Authorized Rep/Branding Changes + Translations
• Declaration of Conformity + UDI inspections in place at DCs
Technical
Documentation Update
(? weeks)
Notified Body
Notification & Planning
(? weeks)
First evaluation by
Notified Body
(40 days)
Response
(15 days)
Second
evaluation
(20 days)
MDCG
(21 days)
Scrutiny
(60 days)
Certification
decision
(15 days)
Submission required for:
• First time products
• Change to products

What factors will slow down the process?
Delays in Notified Bodies receiving their designation to MDR
Notified Body capacity constraints
Additional scrutiny of Notified Body performance
Additional scrutiny of technical documentation by Notified Bodies
Extended process of conformity assessment
 Especially for Class III and implantable devices
Insufficient evidence of compliance with GSPR – remediation and delay
Inadequate clinical data -- remediation and delay
Natural tendency of manufacturers to wait until last moment
Increased scrutiny, NB capacity, insufficient evidence from manufacturers

Significant Change – Notified Body Scrutiny
Articles 35-50 detail the significant changes to Notified Bodies, their designation and
continuous assessment
The process of designation of a Notified Body is complex and may take a long time
 All Notified Bodies are going through this process over ~18 months
 Notified Bodies could apply for designation beginning in November, 2017
Critical review of Notified Bodies assessments of technical documentation and
clinical evaluation documentation
 Translates into pain for industry in CER and technical documentation review
activities
Existing Notified Body structure will undergo a major change, expecting many
Notified Bodies impacted resulting in a potential significant reduction in available
Notified Bodies

22
Notified Body & Talent Capacity
 Now only 59 Notified Bodies – reduced from 83 prior to MDR publication
 Reducing number with Increased workload
 Unannounced inspections
o Manufacturers
o Critical suppliers
 Greater scrutiny in general (e.g. Clinical Evaluations)
 NBOG codes granted to Notified Bodies with MDR designation uncertain
• Will likely affect the scope of some Notified Bodies
 Notified Bodies competing with Manufacturers and Consultants for qualified people
 EN ISO 13485:2016 and MDSAP are competing for NB time and resources
 Some NBs cancelling contracts
 Some NBs not taking on new work
Status and availability of Notified Bodies is uncertain
©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc.

Significant Change – The Role of EUAR
CHANGE
 There are also more prescriptive requirements
placed on EU Authorized Representatives (EUAR)
(Article 11)
 The MDR states that “the authorised
representative should be jointly and severally
liable with the importer and the manufacturer“
 The EUAR will also be required to be registered
and must also have a PRRC
 The MDR extends the scope of the regulation
beyond the device manufacturer to other
Economic Operators in the supply chain
 Distributors and Importers are now specifically
regulated (Article 25) and have specific regulatory
obligations too
EU Authorized Representative
Manufacturers should consider their
entire Supply Chain to ensure that these
provisions are adequately addressed
and agreed with their business partners.
In addition, they should identify a
person who is suitably qualified to
assume the PRRC role. Agreements with
EUARs, if used, should be revisited and
updated together ensuring that EUARs
have defined plans to be registered and
also have appropriate levels of
insurance to cover their new liability.

What about Brexit?
Still so many unknowns – difficult to forecast outcomes
UK policy makers and industry have indicated support for convergence with EU
device regulatory framework i.e. MDR
While the UK remains part of the EU (during transition period) the MDR will be
implemented
Post Brexit, UK regulatory framework will be required
ABHI (UK Trade Association) is working closely with MHRA and policy makers to
ensure harmonization is achieved with EU and rest of global markets
Still unclear regarding roles and responsibilities and impact to UK stakeholders –
some UK Notified Bodies are making plans to relocate Headquarters to EU
High % of total CE markings are issued by Notified Bodies based in UK
 Even higher % of CE markings for Class III devices
Majority of European Authorized Representatives are based in UK
After Brexit, they will no longer be in Europe

25
What should we do to implement MDR?
Some advice…..
Theoris Group, Inc.
Rule 8 Engage Senior Management internally
• Overall plan for timeline and resources
 Review all of your devices against revised classification rules
• Existing products and those under development
• Identify path to CE Mark for any devices with new classification
 Open a dialogue with your Notified Body
• Understand their intentions relative to designation as NB for MDR
• Confirm your interpretation of device classification
• Discuss scheduling considerations
• Agree on path forward and tentative schedule
 Discuss with your current European Authorized Representative
• Confirm their plans in light of new requirements
• Identify potential alternates
 Decide timeline for ISO 13485:2016 readiness
 Identify Person Responsible for Regulatory Compliance (PRRC)

26
What should we do to implement MDR?
Some advice…..
Theoris Group, Inc.
Rule 8 Revise Technical File for each product family
• Annex I – General Safety and Performance Requirements
• Create new checklist to replace “Essential Requirements Checklist”
 Revise and upgrade each Clinical Evaluation Report (CER)
• Complete and comprehensive – Start early!
• Critically examine the clinical data you have, and its adequacy
• Get help from internal and/or external SMEs
 Enhance Post Market Surveillance processes
• PMCF and PSUR
 Review labelling against expanded requirements
• Annex I Chapter III
• UDI
 Determine status of devices with regard to Restricted Substances
• If above threshold, decide alternate materials or strong risk/benefit rationale

Review your product portfolio for possible rationalization
Additional Recommended Activities
Rule 8 Perform a portfolio review to determine what products will remain in the European Market or
require CE Mark for country market use
 Develop exit plan for existing CE Marked devices where re-certification will not be pursued –
complete product EOL prior to certification expiration date
 Review all remaining devices against revised classification rules
• Review existing products and those under development, current MDD classification vs. new
MDR Classification
• Identify path to CE Mark for any devices with new classification

Finding business advantage in MDR
Compliance pioneers can be perceived as having superior systems
 “They’ve cracked it.”
Gain market share when laggards get trapped in bottleneck and fail
Product portfolio rationalization simplifies product support, reduces cost
 Accelerate end-of-life for marginal products
Strengthening technical documentation improves knowledge and confidence
 GSPR evidence
 Clinical evidence
Process of achieving MDR compliance will build new knowledge among key staff
 Internal study and “figuring it out”
 Transfer of knowledge from external resources
See Maetrics whitepaper “Market Opportunity Value of MDR”
Go early, exploit distance from slow adopters, maximize & leverage new knowledge

In Summary
Conformance with the MDR is a significant business challenge that must be
overcome in order to enjoy continued access to the EU market
To meet this challenge, manufacturers must be proactive and begin preparing now
Engage immediately with Notified Body regarding intentions and timeline
Manufacturers must closely follow the emerging regulatory landscape, keeping alert
for the detailed Implementing and Delegating Acts that are required in order to
make the MDR operational
The availability of resources, both internal and external, are likely to prove crucial to
effective implementation
Success will likely require strengthening of technical evidence documents
 GSPR and CER
Executive support and proactive program management of MDR implementation is a
prerequisite for a manufacturer’s success.

Questions & Close

BACKUP SLIDES
31
Theoris Group, Inc.

How Can Maetrics Help You?
Our firm delivers compliance strategies that enable our clients to achieve new efficiencies and adjust to
compliance standards successfully across the life sciences industries’ product life cycle:
REGULATORY COMPLIANCE
 Global regulatory strategies
(FDA/EU/Other)
 Compliance audits & gap
analyses
 Mock inspections
 FDA warning letter responses &
remediation
 Facilities operations review
 CE Mark
REGULATORY AFFAIRS
 US Class III medical device
submissions; EU Class III MDD
submissions (change amendments,
design dossiers)
 Independent regulatory guidance
to product development teams
 Technical file remediation
 EU MDR / MDSAP / ISO 13485:2016
Compliance
QUALITY MANAGEMENT SYSTEMS
 Quality systems auditing
 Pre-certification auditing
 ISO certification readiness
 Batch records documentation
 Master record & technical file
remediation
 CAPA/NCR services
 Auditing, internal & external
 Complaint handling & recalls
PERFORMANCE IMPROVEMENT
 Kaizen event planning
 Mfg process improvement
 Operations/asset utilization (Mfg,
Inventory, DC & Transportation)
 Value Stream mapping & process
standardization & simplification
PRODUCT LIFE CYCLE MANAGEMENT
 Product risk management
framework & risk assessment
 Risk controls to drive results in
acceptance, mitigation, and
avoidance
 Design verification & activities
M&A INTEGRATION & DEAL SUPPORT
 Due diligence
 Regulatory compliance
 Quality Remediation & Operational
Integration
 Product Transfers
 Facility Consolidation
DATA ANALYTICS & REPORTING
 Performance analytics (Vision
Tool)
 Risk mitigation & compliance
awareness
Clinical &
Development
Manufacturing Distribution
Sales &
Marketing
CLINICAL EVALUATION REPORTS (CERS)
 CERs strategies & guidance against
Annex X MEDDEV 2.7/1 Rev. 4
 Data/literature protocol & search
 Full product CERs or updates to CERs
post review (medical writing)
 Internal CER process improvement
P&PC / VALIDATION
 Validation master plan
 Process & product validation
 Computer systems validation
 Equipment validation
 Special processes & procedures
 Test method validation
 Packaging
 Sterilization
TRAINING
 Portfolio of specialized courses in
regulatory, quality, risk
management, sterilization and
contamination control
MEDICAL DEVICES and DIAGNOSTICS
ORGANIZATIONAL CHANGE MGMT
 Due diligence
 Regulatory compliance
 Quality & Operational Integration
INFORMATION TECHNOLOGY
 Strategy & policy
 510(k) device software
development and testing
 Data migration validation
Note: This represents the highest volume of service offerings, but does not represent our entire service capability

EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

Similar to EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck (20)

More from April Bright

More from April Bright (20)

Recently uploaded

Recently uploaded (20)

EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck