MDR Transition Toolkit - ISO Life Sciences · MDR) along the columns of the template. 2. The rows...

MDR Transition Toolkit

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

ISO Life SciencesMDR Transition Toolkit

Copyright 2019 ISO Lifesciences Ltd

3

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

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

ISO Life SciencesMDR Transition Toolkit : Gap Assessment


5

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.

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

ISO Life SciencesMDR Transition Toolkit : Cost Model


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


Number of dedicated Project Managers identified for the program

FTE effort per Project Manager

Cost per Project Manager


# 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


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

ISO Life SciencesMDR Transition Toolkit : Cost Model Budget Planning


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

ISO Life SciencesMDR Transition Toolkit : Transition Planning


9

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.


10

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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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

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.

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


MDR Transition Toolkit - ISO Life Sciences · MDR) along the columns of the template. 2. The rows...

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Transcript of MDR Transition Toolkit - ISO Life Sciences · MDR) along the columns of the template. 2. The rows...