EU MDR/IVDR Readiness : Preparing for the New Regulations 3rd Dec 2015 16:15 to 17:30 Eithne Lee (EY) / Patrice Napoda (YE)

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EY and Your Encore (YE)

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Client’s Objectives Understand the impact of the regulation

Strategic Planning

Visibility and Communication

• Regulation Assessment (AI)MDD/IVDD and MDR/IVDR • Full value chain Impact Assessment • Business strategic impacts Assessment • MDR/IVDR Solution development & Implementation roadmap • Remediation cost estimates • Leadership & Business Alignment • Mobilization and engagement

Winning and delivering by leveraging the capabilities of both EY • Life Sciences expertise • Risk & Compliance Leadership • Global complex value chain and functional transformation change programs • Program leadership & design

Your Encore (YE) • Regulatory and technical leading practices and processes • Subject matter expertise in clinical, technical documentation, regulatory and quality assurance evaluations and solution development

Together, EY /YE and our client’s are working to deliver business value beyond compliance medtechforum.eu

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Session Agenda

MDR/IVDR : Business Readiness ? MDR/IVDR : Program Response Readiness ?

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MedTech Industry Transformation The new EU MDR/IVDR will have far reaching impacts for its many stakeholders. Patients/Healthcare Providers ► Device Safety and Performance ► Information access and transparency

MDR/IVDR

Manufacture to EU

Your Business

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Regulators , Notified Bodies and Reference Laboratories ► Strengthen role through stricter requirements and controls ► Higher technical scrutiny pre- and post- marketing ► Alignment between National Surveillance bodies , Authorities and Reference Laboratories ► Maintaining market access and continuity ► Re-classifications (MDR) and classification changes (IVDR) increases NB role in conformity assessments Payors and Budget Holders ► Pricing and re-imbursement Manufacturers ► Business Continuity - Revenue and Launch plans in key markets (EU and CE authorized markets) ► Financial - Cost of Compliance ► Portfolio/Life Cycle Management– retirements and replacements ► Operating Model changes

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Actions being pursued Many have moved into planning their response, with the growing confidence that the legislation could be finalized in early 2016 Who

When

What

EU Law is developed by EU Commission

Sept 2012

Commission Proposal

EU Parliament propose amendments

April 2014

EU Parliament Amendments

Final version of Regulation will be a compromise between Commission, Parliament and Council version of the text

EU Council propose amendments

Q2 2015

H1 2016

Council Position – Oct’15

Final Adoption (estimated)

H1 2019

H1 2021

End of MDR Transition Period

End of IVDR Transition Period

Transition period of 3–5 years to Implement and validate all Changes

Content of legislation can change until final adoption

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Today

Some details of the legislation will be defined after adoption in further legal acts which will require continuation of advocacy

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Key Messages The new Regulations will be transformational for the Industry and for your Business ► ►

EU Market

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► Regulatory Landscape

► ►

Economic Operators

► ► ► ►

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Cost to operate will increase Early access to technology innovation likely to be impacted due to expected protracted market authorization timelines In the transition period EU ‘first to launch’ markets may not be as attractive Regulation imposes clear and detailed rules which do not give room for divergent transposition by Member States. Introduction of ‘expert panel led’ scrutiny process will be a significant change Impacts for the Notified Bodies are substantial, likely to see further consolidation

Regulatory led, broad business impact Substantial costs to remediate are anticipated Complex change program whilst maintaining ‘business as usual’ Strategic imperative for all businesses which will demand leadership attention

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Business Readiness We observe 3 distinct phases, which will make different demands on the business as they adopt the new Regulations Pre Final Text Leadership Alignment

• •

Business Alignment

• • •

Financial

• • •

Governance

• •

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Text Publication- Day 0

On CEO agenda, transformational impact understood Prioritisation as a strategic imperative for the business

•

On BU/ Functional agenda Prioritisation as a strategic program Gap assessment completed (MDD/IVDD vs MDR/IVDR)

•

Revenue impacts identified Costs to remediate to MDR/IVDR identified Budget provision made for transition year 1

•

Enterprise wide SteerCo operational EPMO – Regulatory Led, planning remit Communications strategy agreed

•

•

•

•

•

Transition (3-5years)

Business response defined Business leadership responsibilities clear to support transition

•

Strategic issue escalation – business continuity

Execution/acceleration of enabler projects to support journey to compliance MDR/IVDR as a business priority understood

• •

Implementation execution Cross business and functional complexity management

Functional budgets for Year 1 allocated Resource allocation to support project provisioned in headcount

•

Budget management

•

Financial reporting

EPMO – implementation remit Validated MDR/IVDR implementation plan

•

MDR/IVDR – ‘one source of the truth’ Implementation management

•

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Business Readiness We have observed different responses from the industry – from ‘an acute need to prepare’ to the ‘wait and see’ Leadership Alignment Transition Day 0 Final Text EY Observation

Governance

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Business Alignment

Financial Planning

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Leadership Alignment – Pre Final Text

Operating Efficiency and Risk Management

Top Line Revenue and Profitability

Regulatory leaders need to look beyond compliance and seek to align MDR/IVDR to the strategic agenda of the Business to engage Business Leadership Competitive Positioning

Portfolio Rationalisation

Niche and small operator impacts :

Prohibitive remediation costs :

• Market expansion opportunities

• Divestment

•

Acquisition targets

• Product retirement

Growth

Consolidation

• Development project reprioritisations

Strategic Agenda Efficiency and Effectiveness MDR/IVDR program opportunity : •

Increase harmonisation and standardisation

Brand Optimisation

Financials

Positioning

MDR/IVDR compliance will drive : • Enhanced patient safety • Greater assurances in product performance.

• Process, IT, People

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Business Alignment – Pre Final Text The new EU MDR/IVDR impacts for Manufacturers will be transformational.

Manufacturers MDR/IVDR

► ► ►

Manufacture to EU

► ►

Your Business ► ►

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Potential need for major investment support to remediate Regulatory led, executed by the business 3-5 year business critical transition timeframe - compliance is not an option EU focus with impacts on global assets and all CE authorized markets Consolidation may be a consequence for smaller and niche manufacturers Transition period could make EU markets difficult launch markets Significant operating model changes to enable MDR/IVDR compliance will require early identification and actions

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Business Alignment – Pre Final Text For your business, preparation for MDR /IVDR will need to be undertaken at multiple levels

MDR/IVDR

Your business ► Aspects of the legislation are yet to be finalized which your business needs to continue to lobby its position ► Classifications ► Scrutiny ► Implant Cards ► Companion Diagnostics ►

Manufacture to EU

Your Business

For multi-franchise businesses a need to conduct a detailed impact assessment ((AI)MDD/MDR&IVDD/IVDR gaps),engaging all functional teams : ► R&D (Product Dev, Clinical Dev, Regulatory, Medical Safety) ► Technical Operations/SC ► QA ► Franchise Strategy Teams/Commercial ► Market Operating Companies ► ► ►

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Investment case Solution strategies to close gaps Transition Implementation plans 11

Financial – Pre Final Text The cost to remediate are likely to be substantial, consequently will need to be planned

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Financial planning against multiple scenarios should be driven by Regulatory and Government Affairs to reflect their considered opinion on what will emerge in the final text

►

Costs will be heavily influenced by the product portfolio and the extent of the remediation required.

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Governance Office – Pre Final Text

► ►

Pre Final Text

Text Publication – Day 0

MDR/IVDR Core Req Program scope, schedule, development

Operate PMO process MDR/IVDR Core Requirements 1. Governance 1. ‘One source of the Truth’ 2. Program Process Mgt 2. External Communications 3. Program Planning & Mgt

Transition (3-5 years) Operate PMO process 1. Governance 2. Issue/Risk 3. Monitoring & reporting

MDR/IVDR Core Requirements 1. ‘One source of the truth’ 2. External Communications

Deliverables

Toolkit

Process

The complexity and interdependencies in both the preparations and the implementation will require a ‘heavy hitting’ PMO.

►

► ►

Assessment Process Management & Deployment Draft Implementation Plan Remediation Cost Model

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PMO processes MDR/IVDR Implementation Plan Financial Plan

Design/Setup

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MDR /IVDR Status Updates

► ► ► ►

Schedule management Issue & risk management

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MDR/IVDR – Legal Acts Updates

Change control Interdependencies Management

Execute

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Session Agenda

MDR/IVDR : Business Readiness ? MDR/IVDR : Program Response Readiness ?

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Program Readiness The program will need to evolve in line with the 3 anticipated phases previously outlined Final Text (imminent)

Program Governance

• •

Regulatory Response

•

Business Response

•

•

• •

Regulatory led MDR/IVDR response process defined Active communications and business engagement and coordination

•

MDD/IVDD-MDR/IVDR compliance changes identified and communicated Participation in Industry /business advocacy

•

MDD/IVDD vs MDR/IVDR gap assessment completed by BU/Function • Product/Portfolio • Operating Model Cost of compliance under MDR/IVDR provisioned

•

The COM and national competent authorities readiness and interdependencies investigated • Notified Bodies readiness and interdependencies investigated • Economic Operators readiness and medtechforum.eu interdependencies investigated

Stakeholder Engagement

Day 0 (Final text publication ~ 6months)

•

Transition (MDR = 3yrs IVDR = 5 yrs)

EPMO moves to execution Finalised implementation plan, budgets and resourcing

•

MDR/IVDR – ‘one source of the truth’ repository

•

•

•

•

•

Sustainability and validation of implementation Change Control support Manage response to transition legal acts Continuation of advocacy role

Validated response and implementation plan against final text Product remediation plans fully integrated across functions

•

Budget management

•

Financial reporting

Validated implementation plans aligned to external stakeholders plans

•

Key stakeholder reviews against plans

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Program Readiness We have observed different responses from the industry – from ‘an acute need to prepare’ to the ‘wait and see’ Program Governance Transition Day 0 Final Text EY Observation

Business Response

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Regulatory Response

External Stakeholder

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Program Governance – Pre Final Text The journey to compliance will require a structured process to be defined for which a plan will need to be built. EY 7-Step Compliance Change Framework Project scope

2 Regulatory Requirement Assessment

Gap Analysis

2

Regulatory Requirement Assessment ► ►

4 Sustainability

EPMO

1

Validate, Report & Compliance

►

Implementation Plan

Implementation

Project Governance Stakeholder Management ► Steering Updates Deliverable Management ► Investment Case ► Implementation Plan MDR/IVDR Scope and Compliance Management ► External Updates (Legislators) ► Internal alignment medtechforum.eu EPMO

Targeted scope

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3

1

Review the status of the Legislation Establish common understanding of impacts for all stakeholders Scope and plan Gap Assessment ► Portfolio focus ► Supply Chain ► Markets

Illustrative MDR/IVDR Scope ►

►

►

All BU/Franchise

►

Pilot

Technical file reviews – sample & extrapolate ►

Gap Assessment Portfolio/Product Evaluation ► Regulatory/Clinical/PMS ► hazardous substances ► MTO/Supply Chain Business Alignment ► QA(QMS/NB) ► Strategic Implications

►

►

► ►

Detailed Change Designs Validated and signed-off with Stakeholders

Implementation Planning ► ►

Design Implementation Roadmap Build investment case

Selected technical file from each device category within a design center to cover device class and stated rules using most complex Class/Rule combinations noted

CER/CSR reviews ►

All Class III and IIb

PMS ►

Selected Affiliates/Manufacturing

►

Medical Safety

►

For hazardous substances gap assessment, consultation in Week 1 to confirm scope is recommended

►

For MTO/SC/QA gap assessment, consultation in Week 1 to confirm scope is recommended.

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For Strategic Impacts EU + (markets CE referenced), baseline data and sources confirmed in week 1 17

Gap Solution Design

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Franchise

Regulatory Response – Pre Final Text Business response needs to be Regulatory led and initiated with the communications of the changes based on a comparison of MDR/IVDR to MDD/IVDD/IVD Key MDR impacts for the Business

Potential actions

Who

►

More stringent NB Control (Designation, CA Auditing)

►

Increased scrutiny from NB in reviews and QMS audits

QA RA

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Increased NB auditing requirements (Unannounced Audits)

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Increased scrutiny and stricter interpretations of requirements in audits,

QA All functions

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No PMA process, but some “SCRUTINY” for a category of high risk devices

►

Increased complexity and time for reviews, anticipate more questions

RA

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Class IIb implants to undergo Design Dossier Review

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Increased complexity & time to complete filing, for NB review. Increased need for Clinical evidence.

RA Clinical R&D

Increased need for Clinical evidence. Increased complexity and time for submissions and review

Clinical RA/ R&D

Update of CER with clinical trial data where necessary for existing and new devices

R&D

►

►

Up-classification of certain device groups

► ►

►

► ►

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More demanding requirements for Clinical Evaluation ► Less options for “Equivalence” – Literature Route (increase of CIT) ► Enhanced PMCF Requirements ► Increased Documentation (CER along whole product Life Cycle) ► “Clinical Specifications” Concept

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More demanding requirements for Vigilance Reporting: 15day time line, Trend Reports

►

New processes to be defined to cover these challenges

QA/RA Medical Safety

Labelling changes (Label, IFU, UDI, Clin. Data Summary, Impl. Cards, Substances)

►

Graphics complexity, potential impact on packaging design & configuration. Potential subsequent packaging equipment impacts.

RA Graphics SC&O

Expansion of data registration to feed Eudamed, Potential Supply Chain impact on Importers,,Distributors, Organitzational re-alignment for AR responsibilities

GSC RA/ QA IT

Organizational re-alignment for new regulatory responsibilities. Multiple other QMS changes to incorporate all new requirements.

QA/RA Compliance

Clinical

► ►

Economic Operator/Product Registration (EUDAMED: MFG, AR, Importer, UDI)

► ►

►

QM-System changes: regulatory responsible person concept

► ►

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Business Response – Pre Final Text To plan for compliance implementation, an extensive gap assessment between MDD/IVDD and MDR/IVDR will be required. MDR

R&D

Supply Chain

Regulatory Affairs

Quality Assurance

Commercial

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IVDR

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What proportion of our portfolio’s are implicated by the restrictive substance changes?

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Will we have extensive Clinical Investigations to be conducted for our high risk devices?

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What are the impacts of up-classification (MD) and new classifications (IVD)

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What is the impact on our Economic Operator network?

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How does UDI under MDR/IVDR differ from the US UDI solution?

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How does language specific labelling impact packaging design ?

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Will the current ‘artwork’ process be capable of handling the MDR/IVDR labelling complexity?

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Can current processes handle the anticipated volume of complaints and questions from the authorities?

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What level of change do we have in our technical files?

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How many of our products have up to date PMS plans?

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How will our re-certification plans be impacted in the transition period?

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Do we need to align with our NB’s on how the new MDR/IVDR will be assessed?

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Is our QMS up-to-date and able to deal with all the changes?

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Which companies will revise their business model?

►

What new market strategies will be developed by competitors?

►

Which companies will withdraw products from the market?

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To what extent is incremental innovation still adding business value when compliance costs increase? Is a more radical approach more profitable?

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Your Readiness If the MDR/IVDR is finalised in Q1 2016 – Are you prepared?

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Back-Ups

Key IVDR changes (1/2) With some notable similarities between the MDR and IVDR changes in product identification, surveillance and manufacturing release

Clarification and extension in the scope of the regulation :

►

► ►

►

Devices manufactured and used within a single health institution; Tests providing information about the predisposition to a medical condition or a disease and tests providing information to predict treatment response or reactions (e.g. companion diagnostics); Software, which is explicitly mentioned in the definition of IVD’s

The Regulation will apply from the point a product is made available rather than the point it is placed on the market

►

Proposed Key IVDD Changes – Classification •

It will employ classification ( A (lowest risk),B,C,D) and conformity routes based on the IMDRF but adapted for the EU regulations

•

Further requirements for in-house assays, Class D devices will be fully under the scope of the IVD Regulation, Classes in A, B and C used within a single healthcare institution are exempt from the regulation provided they are made and used in an accredited laboratory

•

Specific definition and requirements for Companion Diagnostics they are defined as a device intended to select patients with a previously diagnosed condition or predisposition for eligibility of treatment with a specific medicinal product and will become class C devices

•

Specific definition and requirements for devices for near patient testing these include devices intended to perform testing outside a laboratory environment by a healthcare professional not necessarily a laboratory professional, generally near to, or at the side of, the patient and will be regulated in a similar way to self test devices

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Key IVDR changes (1/2) With some notable similarities between the MDR and IVDR changes in product identification, surveillance and manufacturing release. Proposed key IVDD Changes – Key Product Changes •

New labelling requirements including UDI requirements

Who R&D, Global Supply Chain

•

Economic Operators will be required to identify who supplied them and to whom they supplied IVD’s

•

There are increased requirements for post-market surveillance (PMS) including a PMS plan a post-market clinical follow-up plan and post-market clinical follow-up evaluation report proportionate to the risk class

•

Class C and D will also have to report any statistically significant increase in the frequency or severity of incidents that are not individually serious incidents, but have an impact on risk-benefit analysis

•

Commission proposes to set up and manage an electronic system to collate and process reports by Manufacturers on serious incidents, field safety notices and corrective actions and periodic summary reports (PSR’s)

•

Increased clinical evidence will be required to demonstrate conformity with the general safely and performance requirements. The Clinical Evidence Report (CER) will have to contain a summary of the scientifically validated data, the analytical performance data and clinical performance data

Clinical, Regulatory

•

Each manufacturer and authorised representative will require a Qualified Person with 5 years IVD regulatory experience to be responsible for the conformity of batches to be released, maintenance for the technical documentation and declaration of conformity plus vigilance reporting

Tech OPS Regulatory Med. Safety

Med Safety, Regulatory, Market OPCo’s

Proposed key IVDD Changes – Key Authorisation Changes

Who

•

The Notified Body will have to inform the MDCG of all new Class D applications and submit a summary of safety and performance, the MDCG can request additional information within 15 days and additional information within 90 days, this does not apply to changes to existing products

QA

•

The regulation will establish the requirements for a network of reference labs which will support the establishment of the state of the art, creation of CTSs and pre-certification independent testing to the CTS, support the verification of manufactured product for Class D and other testing requirements needed by the Competent Authority or Notified Body

R&D Regulatory QA

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R&D impacts The MDR/IVDR impacts will be extensive =, with the changes to be applied retrospectively on all products and to those in the pipeline MDR

Product Development

►

Hazardous substances labelling will require exhaustive BOM inventories

►

Consideration of alternative substances or justification maybe a requirement for hazardous substances

►

Summary of safety and performance for all implants and class III devices. Summary publicly available to patients

►

Post-Market clinical follow-up plan (PMCF) and report for each CER to assess long term safety and performance

Clinical

►

►

All class III and implants require clinical investigations, use of equivalence may be reduced

►

►

Equivalence data will need to include usability in addition to intended use, technical and biological data

►

Technical file impacts vary from administrative to the more complex including general safety and performance requirements, validation testing, labelling and DoC translations

D : ~ List A devices C & B : majority of IVD’s ► Class A : self –assessment ( excl = near patient testing, measuring, sterile) Analytical performance and clinical performance will be required to demonstrate conformity with the general and safety performance requirements ► Class

►

Technical Files

Significant changes to the classification system for IVDs and to the conformity assessment procedure ► Class

More emphasis on comparative device evaluation may be a requirement in the clinical evaluation

►

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IVDR

►

CER will have to contain a summary of the scientific validity, the analytical performance data and clinical performance data

Technical file impacts largely to align with the classifications and assessment changes

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Market vigilance and surveillance impacts More stringent reporting with significant impact on the role of Medical Safety and local Regulatory teams MDR

Vigilance

►

►

Reporting

PSURs

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Healthcare providers, users and patients will be encouraged to report more complaints

Manufacturers to report adverse events within 2-10-15 days depending on the seriousness

IVDR

►

Healthcare providers, users and patients will be encouraged to report more complaints

►

Manufacturers to report on serious incidents, field safety corrective actions, field safety notices

►

For Class D & C reports on any statistically significant increase in the frequency or severity of incidents that are not individually serious incidents, but have an impact on the risk-benefit analysis

►

PMS plans have to be part of the Tech File and kept up to date

►

To be drawn up and updated annually for all devices

►

►

To be reviewed for high risk and implantable devices by the Notified Body, the outcome of the evaluation to be reported to the Authorities

NB to assess and send evaluation to National Competent Authority via EUDAMED for Class C&D devices

►

For all other devices – make PSUR’s available upon request.

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Manufacturing operations and supply chain impacts The revised labelling requirements will introduce much complexity to the EU packs and any packaging operations supplying the EU markets MDR Labelling

Re-processing

Implant Cards

IFU

Tech Operations

► ►

This is a medical device’ proposed as a requirement EU Authorised Representative and address UDI

►

Re-processing cycle information required on label

► ►

Lay friendly and language specific Information allowing identification of the device including UDI Expected lifetime of the device and any follow-up, warnings and precautions

►

►

Lay friendly/stakeholder review and language specific labelling specifically for lay use devices ► Single use/re-use risk ►

► ►

Supply Chain

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► ► ►

Operating model changes to absorb both volume, complexity and potential label/pack design changes Global Data Management including product codes

Lay friendly/stakeholder review and language specific labelling Single use/re-use risk Serious incident feedback

IVDR ►

EU Authorised Representative and address

►

UDI

►

In case of devices classified as Class C or D summary of safety and performance with key elements of the supporting clinical data to be publicly available.

►

Potential label/pack design changes

►

Global Data Management including product codes

►

Lay friendly/stakeholder review and language specific labelling Serious incident feedback

►

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QA impacts The pervasive business impact will be very evident by the extensive changes needed to QMS MDR

QMS

Notified body strategy

►

‘Extensive revisions to both quality manual and procedures – Corporate, Business Unit and local levels

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Technical documentation, risk management, clinical evaluations, labelling, QP, vigilance and surveillance, NB drive key changes

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Increased standards for Notified Bodies with introduction of special NB’s for class III and implants

►

►

Recertification

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IVDR

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Class D,C & B product Manufacturers audit by the NB will incorporate a QMS assessment

►

New Classification System will require the following NB interventions

A different NB landscape may require consolidation to established NB’s and recertification, re-designated starting 6 months after publication

New conformity assessment procedure includes the requirement for more frequent unannounced inspections and includes supply chain and traceability

►

Technical documentation (class III dossiers/technical files) availability for products requiring NB review for certification

►

Global markets (AUS, CAN, Saudi, Korea) where CE is used will need consideration

►

►

Class D : pre-approval of the design, QMS and batch verification

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Class C : Representative technical documentation review and QMS

►

Class B : QMS assessment

5 year compliance timeframe due to the changes in the classification system for IVDs, new clinical evidence requirements and the conformity assessment procedures.

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Commercial impacts The potential market impact due to portfolio changes may be significant both due to product losses and competitor changes MDR

Portfolio Management

Product Life Cycle

Product Changes

IVDR

►

Launch strategy – EU as the initial launch markets may need to be reviewed for the transition period.

►

The more stringent clinical evidence requirements to support new registrations may extend authorization timelines

►

Acceleration of model changes and developments could be more viable than product withdrawal or remediation

►

Margin impacts due to the costs to remediate products may be substantial in the case of those products implicated by the hazardous substance and clinical evidence changes

►

Competition and specifically from smaller operators may provide market growth opportunities

Competitors

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