mdr transition toolkit - iso life sciences · mdr) along the columns of the template. 2. the rows...
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MDR Transition Toolkit
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Our Approach : Accelerate2Compliance©ISO Life Sciences proprietary approach to conducting Regulatory Compliance programs
• Solution Development
•Cost Model & Decision Support
•Sustainable Implementation
• Pre-Audit Assessments
•Compliance Recertification
• Regulatory Gap Impact
Assessment
•Business Gap Impact
Assessment
•Regulatory Gap Assessment
•Business Impact Definition
Define2 Plan
Assess2Comply
Solution2 Change
Implement2Renew
PMO2
3
4
1
5
© Copyright 2018 ISO Life Sciences
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ISO Life SciencesMDR Transition Toolkit
Copyright 2019 ISO Lifesciences Ltd
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Our MDR Transition Toolkit is modularised to provide each functional team with a common process to follow.
MDR Transition Workbooks:
1. Technical Documentation and Labelling (Chpt V, VIII & Annex I,II & IX)
2. Clinical (Chtp VI & Annex XIV/XV)3. Hazardous Substances (Annex I.10)4. Vigilance (Chpt VII & Annex III)5. Regulatory Affairs (Annex IV, V, VI, XII)6. Supply Chain (EO) (Chpt II & III)7. Quality Management System (Annex VII &
IX)
EU MDR Technical Documentation Assessment Worksbook v1.0
Client Name :
Date of Assessment :
Workstream No :
Workstream Team :
This workbook is an asset of the ISO LS Ltd business with agreement for use to specificied clients under
contractual and hence Intellectual Property & Copyright protection. Copying or use of the workbook
beyond the named client and workstream members above is strictly prohibited.
Contents
Instructions for USE
1.0 Assessment Templates
2.0 Solution Template
3.0 Cost Model
4.0 Transition Planning
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ISO Life SciencesMDR Transition Toolkit
Copyright 2019 ISO Lifesciences Ltd 4
Each functional workbook is structured in a consistent way
MDR Transition Workbooks:
1. MDR explained (subject matter specific based on ISO LS MDD-MDR Reference Model)
2. Instructions for use of workbook3. Gap Assessment templates4. Summary Conclusions5. Extrapolation Trends6. Solution Template7. Cost Inputs8. Transition Planning
Tab # Tab Name Content Objectives Instructions
1.0 to 1.2
inclusive
1.0 Annex I,
1.1 Annex II,
1.2 Annex III
1.3 Annex IV
1. Contains an inventory of all of the new
requirements (delta between MDD and the new
MDR) along the columns of the template.
2. The rows capture the gap assessment findings/
extent of the gap/ and solution proposal against
each requirement for each of the selected sample
Technical Documents to be reviewed.
1. The template serves to capture the findings
made by the reviewer for each of the Technical
Documents to undergo a detailed gap
assessment.
2. The assessment of the technical documentation
in a consistent way will enable the team to assess
commonalities and trends across the full inventory
of technical files to support the extrapolation
exercise later in the process.
3. The assessment of the technical documents will
enable the team to establish commonality in
solution proposals and will inform the transition
plan etc.
1. Identify the Technical Document being
assessed (Columns A to H)
2. There are 3 rows to be completed (all columns
from P to the last column on the right) and for
each of the requirements listed complete the
following
a) an assessment of the size of the gap where
RED is high evidenced by a clear gap i.e. No
evidence of fulfillment against the requirement.
AMBER is medium evidenced by some of the
requirement being fulfilled. GREEN is NO gap
was found.
b) The second sell requires a written rationale to
explain the compliance gap and what it was that
was or was not evidenced.
c) The third cell provides an initial statement on
what solution proposals need to be considered.
1.3 Summary
Conclusions
Please capture a narrative on what the major
conclusions of the gap assessment findings are.
Suggestions are to use filters on the tabulated
findings to analyse.
The consolidated view of all of the gaps enables
priorities, trends and commonalities to be
confirmed
Convene a workshop with critical stakeholders to
work this process
1.4 Extrapolation
Trends
Please capture a narrative on what the major
conclusions of the gap assessment findings are as
it relates to the observed trends and
commonalities observed within the sample used.
The extrapolation trends will support the solution
development and the quantification of the solution
efforts for the cost model
Convene a workshop with critical stakeholders to
work this process
2.0 Implementation
Projects
Summary
Template
Captures an inventory of all proposed solutions
across the extrapolated business requirements.
The solution proposals captured in the gap
assessment worksheet combined with the
extrapolation conclusions should be used and
consolidated into a set of implementation projects.
A set of generic solutions are populated within the
template, please edit and add appropriate to the
the businesses specific scenario. At a minimum
the information requested needs to be completed.
3.0 Cost Inputs
Template
Captures for each of the implementation projects
all costs which will be inserted into the
consolidated Compliance Cost Model.
Each of the Implementation projects needs to be
transferred to the Cost Input template and all data
inserted as requested.
A set of generic implementation projects/costs are
populated within the template, please edit and
add appropriate to the the businesses specific
scenario. At a minimum the information requested
needs to be completed
4.0 Transition
Planning
Template
Captures for each of the implementation projects
all priorities, interdependencies and sequencing
requirements for consideration in building the
consolidated Transition Plan. This worksheet will
be used as a critical input for the Transition Plan
build being undertaken by the PMO
Each of the workstream will have a set of
implementation projects which will be undertaken.
In advance of constructing a consolidated
Transition Plan for the business each workstream
needs to identify priorities, interdependencies
and/or sequencing requirements both within its
own workstream and across all workstreams
Firstly, identify within your own workstream
priorities, sequencing and interdependencies for
implementation paying particular attention to
resource availability, it is likely you will need to
address capacity bottlenecks!
It is proposed that meetings should then be
convened with other workstreams as appropriate
to resolve competing priorities, interdependencies
and sequencing needs.
Technical
Documentation
An assessment of the Technical Documentation (Technical File/Design Dossier/Labels/Promotional Materials) will be conducted against a representative sample, the
findings from the sample assessment are then extrapolated across the product portfolio.
The success of a 'sample & extrapolation' approach is based on the selection of a representative sample of the business's total TF number. The criteria to be used in the
selection of the sample should include the following representation : Classification ; R&D Centres ; Notified Bodies ; Age Profile ; Unique Features (Animal Tissue etc) and
should number between 15-30% of the total TF's. The sample should include potential upclassification /software TF's. The numbers of the selected classification should be
skewed towards the higher class products particularly Class III/IIb implantables
The same sample TF Documents should be reviewed against tabs 1.0 to 1.2
Labeling
Assessment
The outputs generated against the new EU MDR labeling requirements ( Annex I, Chapter III : Requirements regarding the Information Supplied with the Device) will support
the gap assessment to be undertaken within the Packaging Operations Workstream. Early identification of the extent of the text and translation gaps which will need to be
closed, will serve as a critical data input to that workstream.
illustrative
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ISO Life SciencesMDR Transition Toolkit : Gap Assessment
Copyright 2019 ISO Lifesciences Ltd
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Annex Section Annex II, 1.1 (a) Annex II, 1.1 (a) Annex II, 1.1 (b),
Article 24, 4c
Annex II, 1.1 c Annex II, 1.1 (d) Annex II, 1.1e Annex II, 1.1 (f) Annex II, 1.1 (g) Annex II, 1.1 (h) Annex II, 1.1 (i) Annex II, 1.1(j) Annex II, 1.1 (k) Annex II, 1.2 (a) Annex II, 1.2 (b)
Change ID Tech 01 Tech 02 Tech 03 Tech 04 Tech 05 Tech 06 Tech 07 Tech 08 Tech 09 Tech 10 Tech 11 Tech 12 Tech 13 Tech 14
Related QM/ SOP
EU MDR DELTA
Requirements
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD. Annex VI is a
new series of
requirements for
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Annex II is a new
Annex, no such
requirements exist
in the Current
MDD.
Assessment
Product or Trade
Name available
Device Description,
including its
intended purpose
and intended user
UDI device
identifier and the
basic UDI devices
identifier or
otherwise clear
identification by
means of product
code, catalogue
number or other
Intended patient
population and
medical conditions
to be diagnosed,
treated and/or
monitored and
other
considerations such
as patient selection
Principles of
Operation and its
mode of action
scientifically
demonstrated, if
necessary
Risk Class and the
justification of the
applicable
classification rule
according to Annex
VII
Explanation of any
novel features
Description of
Accessories, and
any Other Medical
Devices and
products that are
not Medical
Devices to be used
in Combination
List of Various
Configurations Or
Variants which will
be made available
•General
description of the
key functional
elements, e.g. its
parts/components
(including software
if appropriate),
•its formulation,
•its composition,
•Description of
"Raw" Materials
incorporated into
key functional
elements
•those making
either direct
contact with the
human body
•Technical
Specifications
(features,
dimensions and
performance
attributes)
•Any
variants/configurati
ons and accessories
Overview of the
manufacturer’s
previous
generation(s) of the
device, if such exist;
Overview of
identified similar
devices available
on the EU or
international
markets, if such
exist
Gap Level
Evidence
Solution Proposal
Gap Level
Evidence
Solution Proposal
Gap Level
Evidence
Solution Proposal
Gap Level
Evidence
Solution Proposal
Gap Level
Evidence
Solution Proposal
Gap Level
Evidence
Solution Proposal
Gap Level
Evidence
Techical Documentation Review
Sam
ple
ID
Tech F
ile o
r P
roduct
Nam
e
Ris
k C
lass
Fra
nchis
e
Pro
duct
Lin
e
Desig
n C
ente
r
Manufa
ctu
ring S
ite
Notified B
ody
Is P
roduct
an I
mpla
nt?
Does P
roduct
Conta
in A
nim
al T
issue?
CE
R N
um
ber
CE
R R
evis
ion N
um
ber
CE
R D
ate
Annex II, Technical Documentation (1.1 to 1.2) illustrative
• We advise a ‘sampling and extrapolation’ assessment approach, using representative products e.g. class, R&D centres, age, exceptions etc.
• We assess all aspects of the new text based on the MDD-MDR deltas and we advise on what to assess.• We use a traffic light system to grade the gaps.
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ISO Life SciencesMDR Transition Toolkit : Solution Development
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illustrative
Each team undertakes an extensive review of the gap assessment conclusions and extrapolates the findings in a solution set.
Solution Proposals:
1. Gap Summary2. Where and to whom it is
applicable3. Interdependent Solutions4. Solution Proposal5. Solution Activities and Ownership6. Solution Timeframes7. Solution Resources8. Key Costs
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ISO Life SciencesMDR Transition Toolkit : Cost Model
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Inputs
Overall Inputs
Cost of FTE / Salary assumptions Estimate FR1 FR2 FR3 Data Confidence Level Detail of assumption Next steps
Cost of FTE (Leadership)
Cost of FTE (Director) $ 350,000 M
Cost of FTE (Manager) $ 190,000 M
Cost of FTE (Junior) $ 100,000 M
Cost of FTE (Blended, when level is unknown) $ 200,000 M
Cost of FTE (Researcher) $ 250,000 M
Cost of FTE (Blended, external) $ 440,000 M
Cost of External $ 250,000 M
Standard time values Estimate FR1 FR2 FR3 Data Confidence Level Detail of assumption Next steps
Hours / Day 8 H
Months / year 12 H
Weeks / year 40 H
Hours / week 45 H
Hours / year 1760 H
Company Figures Estimate FR1 FR2 FR3 Data Confidence Level Detail of assumption Next steps
# of franchises
# of manufacturing sites
# of R&D sites
Other Estimate FR1 FR2 FR3 Data Confidence Level Detail of assumption Next steps
Evaluation Points Specific Inputs
Company Figures Estimate FR1 FR2 FR3 Data Confidence Level Detail of assumption Next steps
Number of dedicated Project Managers identified for the program
FTE effort per Project Manager
Cost per Project Manager
Company Figures Estimate FR1 FR2 FR3 Data Confidence Level Detail of assumption Next steps
# of current QMS
# of internal auditors attending training
# of training locations
# of internal auditors for internal review
Travel cost per internal auditor
Internal auditor cost per hour
# of hours per day required for internal audit review
# of days per week required for internal auditors review
$ cost of notified body review
# of sites will need a QMS readiness assessment
$ for resources to update QMS readiness materials
# of notified body quality certificates
# of notified body design examination certificates
Does the QMS include at least aspects (a) to (m) of Article 10.9?
Do the conformity assessment procedures comply with Article 52?
Are the procedures compliant for conformity assessment of reusable surgical instruments?
Are procedures ready for the clinical evaluation consultation procedure for certain class III and class
IIb devices?
Has a system for risk management been established, documented, implemented and maintained as
per Section 3 of Annex I?
# of Standard Operating Procedures (SOPs) that need to be updated for Procedural Updates?
$ (average) for updating procedures
Incremental training for MDR SOP updates
Company Figures Estimate FR1 FR2 FR3 Data Confidence Level Detail of assumption Next steps
Number of reports submitted after 15 days per year
Number of quality complaints for which exemption rules no longer apply
Average FTE hours to respond to an initial report
Average FTE hours to create a follow up report
Average FTE hours to create a final report
Quality Systems (QMS)
Company Information
PMO
Vigilance (VIG)
Our cost model to support budget planning and investment decisions with your financial teams
Costing structure :1. PMO2. Design Verification and Validation3. Clinical 4. Technical Documentation5. Labelling6. Vigilance7. Technical Operations8. Supply Chain9. Vigilance10. Hazardous Substances
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ISO Life SciencesMDR Transition Toolkit : Cost Model Budget Planning
Copyright 2019 ISO Lifesciences Ltd 8
5.3 Vigilance
0% Solution ID Solution Description Cost
Occurrence
Total Solution Cost Internal
FTE
External
FTE
External
Spend
Sanity
Check2017 2018 2019 2020 2021
Sanity
Check
VIG.01 Update systems and processes One-time - 60% 40% 100% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
VIG.02 Increased complaint handling costs Ongoing $ - 60% 40% 100% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
VIG.03 Incremental training for MDR vigilance process updates One-time $ - 60% 40% 100% #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Inputs 0
0.0
0.0
0.0
0.0
0
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
Solutions
Number of reports submitted after 15 days per year
Number of quality complaints for which exemption rules no longer apply
Average FTE hours to redesign the complaint handling process
Average FTE hours to respond to an initial report
Average FTE hours to create a follow up report
Average FTE hours to create a final report
FTE/Spend Spread Annual Spread
Additional FTE cost for managing increased number of complaints
Cost for technology changes to complaint handling system e.g. interface with Eudamed etc.
Is there a system for recording and reporting of incidents and field safety corrective actions as per Articles 87 and 88?
Are measures in place to provide sufficient financial coverage in respect of potential liability under Article 10.16 in the MDR?
Cost to implement systems and processes to track and assess trends in incident and serious incidence by product family
Incremental training for MDR vigilance process updates
Additional FTE to manage the increased number of complaints going forward
• Our cost model identifies the cost breakdown in resources (internal & external), fixed costs (IT systems, headcount etc.) and variable costs (translations, clinical studies etc.) against each solution
• We look at the phasing of costs over the transition period to support budget planning
illustrative
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ISO Life SciencesMDR Transition Toolkit : Transition Planning
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Solution ID Solution Description Dependency /Seq Critical Path Completed By Started By
Transition Planning TemplateWorkstream Interdependencies/Sequencing ID Priority
Solution ID Solution Set Solution Proposal OwnershipEst Start
DateDuration
illustrative
• MDR transition planning is complex!
• Whilst gap assessments and solution proposals can be undertaken functionally, transition planning needs to be done cross functionally, as prioritisation and sequencing will need to be considered at the program level.
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Copyright 2019 ISO Lifesciences Ltd
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ISO Life SciencesMDR Transition Toolkit : MDR Compliance Readiness Review
EU MDR Technical Documentation Audit Assessment Worksbook v1.0
Client Name :
Date of Audit Assessment :
Workstream No :
Workstream Team :
This workbook is an asset of the ISO LS Ltd business with agreement for use to specificied clients under
contractual and hence Intellectual Property & Copyright protection. Copying or use of the workbook
beyond the named client and workstream members above is strictly prohibited.
Contents :
Instructions for USE
1.0 Audit Assessment Templates
2.0 Audit Report
Our MDR Transition Toolkit also includes a suite of MDR compliance readiness tools.
We use a structured process aligned to a typical Notified Body auditing process
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© Copyright 2018 ISO Life Sciences
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Scoping Phase
Assessment setup▪ Documentation Access Confirmation▪ Content sufficiency check
1
Assessment preparations▪ Lead Assessor & Assessor team
assignment ▪ Checklist confirmations (Annex I,II
and IX only)
2
Scoping PhaseScope & Plan Review
Assessment Planning▪ Lead Assessor & Assessor (s) assigned ▪ Assessor review plan confirmed and
Plan-Do-Review schedule agreed
A
Evaluation Phase
Assessor Report Generation
▪ Assessment Report▪ Consolidated Report & Assessor Team
Review
Client /Stakeholder de-brief
▪ Assessment findings and recommendations feedback
Evaluation PhaseAssessor Reporting
Assessment Report Sign-Off▪ Quality Procedure Review Report▪ Technical Documentation Report▪ Pilot conformity findings, trends &
recommendations
C
Concept Phase
Quality Review▪ Draft procedure reviews
Technical Documentation Review▪ Annex I - GSPR▪ Chapter I – General Requirements▪ Chapter II – Design & Manufacture▪ Chapter III – Information Supplied with the
device
▪ Annex II – Technical Documentation▪ Annex IX – Conformity Assessment▪ Chapter II – Technical Documentation
Class IR (Instrument sets)▪ Article 52.7(c) for▪ Annex XI (Part B)
Concept PhaseExecute Review
Assessment Reviews ▪ Completed Annex checklists by
Assessors▪ Consolidated pre-audit checklist
completed & reviewed by Assessor Team
B
3
4
5
6
illustrative
ISO Life SciencesMDR Compliance Readiness Review : We use a structured process aligned to a typical Notified Body auditing process
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Who to contact for more information….
Eithne Lee
► Mobile: +44 (0)79 397 22060► Email: [email protected]
ISO Life SciencesMDR Transition Toolkit : Our Proposition
• We can provide a TOTAL solution to your MDR transition to include PMO, process and resource support.
• We can provide MODULAR support in any aspect of your MDR transition e.g. Supply Chain, Clinical, QMS etc.
• We can provide PROCESS support to your MDR transition by providing access to our proprietary toolkit.
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Why ISO Life Sciences ?We have a clear value proposition
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▪ We are recognized as a differentiated consulting company
▪ Our portfolio of regulatory competences includes – auditing and submission expertise in the EU.
▪ Relevant therapeutic knowledge in Orthopaedics, Endoscopy and Wound Care.
Our strengths
▪ We have in-depth knowledge and expertise in the Medical Devices Sector including Regulatory, Clinical & Safety, Product Development, Quality, Post Marketing Surveillance, Manufacturing & Supply Chain
▪ Proven track record of success in delivering regulatory compliance projects
Medical Devices IndustryExpertise
▪ Unique combination of technical and business expertise
▪ Experienced team with personnel experiences in delivering EU MDR programs with multiple client teams
▪ Pragmatic, coaching, and collaborative working style with strong focus on delivery
Our Team
▪ We invest to innovate through our strategic collaborations, industry papers and participation at international conferences
▪ We have a multi-sector Life Sciences focus and share expertise and experiences across sectors
Thought Leadership and Innovation
Benefits for S&N
Best-in-class Technical Expertise
© Copyright 2019 ISO Life Sciences