transition to the mdr a practical approach & interactive ... · mdd certificate validity (4...
TRANSCRIPT
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© 2016 Holland Innovative
Transition to the MDR a practical approach
& interactive session
Holland Innovative
June 2018
Lisette van Steinvoren, MSc.
Sr Project Manager Medical
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© 2016 Holland Innovative
The core of Holland Innovative
Automotive HealthEnergyHigh Tech Agro & Food
Products Careo ASMLo Philipso NXP
o Siemenso Deltao Essent
o Boscho DAFo Automotive NL
1Confidential WoW HI Health
o FooDso Greentech
o Start-upso MKBo Multinational
© 2016 Holland Innovative
Medical Innovations accelerated
Products
Personalizedmammographic compression.
Role HI: Customer need identification; fact based design, CE approval, project management
Diagnosing aseptic loosening in knee arthroplasty
Role HI: Optimal designed prototype’s and project assurance.
Noviomini tracks bladder filling
Role HI: Customer need identification, risk management, project outline
Development of an integrated PET MRI coil
Role HI: Customer need identification, project management, clinical trial support, risk management
3D Scoliose drill guide
Role HI: CTQ definition,Projectmanagement
Ultrasound sonocoat visibility
Role HI: Quality management (ISO 13485), project management process stabilization and optimization
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© 2016 Holland Innovative
Holland Innovative Medical is able to support
Product
Project management compliant with medical regulations
Identifying the complete set of customer needs (the Voice of the Customer)
Translating customer needs in product requirements (CTQs)
Risk management to ensure a safe product (ISO 14971, FMEA)
Design for Six Sigma to create and optimise high quality design
Reliability engineering to meet customers lifetime requirements
Statistical analysis to describe and analyse Design and Process variation (verification & Validation)
Facilitating Design reviews
The certification processes according to CE and FDA approvals
Quality
Set-up a Quality Management System
Transition from ISO13485:2012 to ISO13485:2016
Training on QMS topics
Improvement of Procedures, FRM’s an WI’s, together with the process owners, to create Lean process
Transition from MDD to MDR
Set-up & Manage complete transition project
Coach QMS department
Training
Gap-analyses
Company Confidential Holland Innovative 5
© 2016 Holland Innovative
Agenda
Status Check: where are you?
Determine your goal
Gap’s relevant for every Economic Operator
Plan of Action: an example Read Delta’s Cluster Close
When time is left: Challenging topics: Let’s learn from each other System Validation Equivalence ..
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© 2016 Holland Innovative
Status Check Regarding MDR compliance within your company
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For all Economic Operators:
Where is your management?
Where are you?
© 2016 Holland Innovative
Agenda
Status Check: where are you?
Determine your goal
Gap’s relevant for every economic operator
Plan of Action: an example Read Delta’s Cluster Close
When time is left: Challenging topics: Let’s learn from each other System Validation Equivalence ..
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© 2016 Holland Innovative
Transition Timelines
26 May 2017Entry in to force MDR
Transition period of 3 years
26 May 2020Application of MDR
MDD certificate validity (4 years)
June 2022Annex IV certificates expire
No more MDD devices on the market
26 May 2024Last MDD certificates expire
MDD certificates: Max 5 year expiry from issue / renewal data
Today
November 2017Apply for Designation by NoBo’s under MDR
Designation approx. 1.5y
MDR Certificates
~ Q2 2019Apply for MDR cert
No significant changes in design or intended purpose
© 2016 Holland Innovative
Example Goal
26 May 2017Entry in to force MDR
Transition period of 3 years
November 2017Apply for Designation by NoBo’s under MDR
Designation approx. 1.5y
26 May 2020Application of MDR
MDD certificate validity (4 years)
June 2022Annex IV certificates expire
MDR Certificates
No more MDD devices on the market
26 May 2024Last MDD certificates expire
MDD certificates: Max 5 year expiry from issue / renewal data
Today
~ Q2 2019Apply for MDR cert
Get MDR Ready
Internal MDR audit
Ready to apply
The goal is to: Have the Company X system & procedures ready to create or update a technical file according to the MDR per December 2018
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© 2016 Holland Innovative
What is your goal?
26 May 2017Entry in to force MDR
Transition period of 3 years
November 2017Apply for Designation by NoBo’s under MDR
Designation approx. 1.5y
26 May 2020Application of MDR
MDD certificate validity (4 years)
June 2022Annex IV certificates expire
MDR Certificates
No more MDD devices on the market
26 May 2024Last MDD certificates expire
MDD certificates: Max 5 year expiry from issue / renewal data
Today
~ Q2 2019Apply for MDR cert
? Ready to apply
The goal is to:……
? ? ? ?
© 2016 Holland Innovative
Agenda
Status Check: where are you?
Determine your goal
Gap’s relevant for every economic operator
Plan of Action: an example Read Delta’s Cluster Close
When time is left: Challenging topics: Let’s learn from each other System Validation Equivalence ..
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© 2016 Holland Innovative
Article 5 – General safety and performance requirements
Essential requirements changed into GSPR
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Article 15 – Person responsible for regulatory compliance
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Article 25- Identification within the Supply chain
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Article 27 – Unique Device Identification
Medical device
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Article 31 – New responsibilities for economic operators
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Article 30 – European database on medical devices
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Article 83 till 86: Post market Surveillance
Annually update:
Reporting deadlines
Always immediately, but never later then:
Serious public health threat: 2 days Event of death or serious deterioration: 10 days - Serious incidents: 15 days
© 2016 Holland Innovative
Agenda
Status Check: where are you?
Determine your goal
Gap’s relevant for every economic operator
Plan of Action: an example Read Delta’s Cluster Close
When time is left: Challenging topics: Let’s learn from each other System Validation Equivalence ..
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© 2016 Holland Innovative
There is no 1 size fit’s all…….
… therefore this presentation focuses on a practical approach, which you can use (hopefully) to manage your own transition
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Project plan MDD to MDR
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The goal is to: Have the Company X system & procedures ready to create or update a technical file according to the MDR per December 2018
Company X is a legal manufacturer of Medical Accessories, used in imaging of Class IibThe company has several locations and own development & production facilities
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Work packages | Main deliverables & Deadlines
1• Prepare
& Kick-off
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• Delta’s & Gap’s
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• Business decision’s
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• Close-gap’s
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• Intern Audit
30-1-2018 15-4-2018 1-6-2018 1-9-2018 1-10-2018
Matrix impact of Gap’s Proposal: Strategic Decision per
product group
Internal Audit on MDR readiness of QMS (does this procedure result in MDR approved products?)
Internal Audit on 1 or 2 Technical files according to MDR
Q1 2019
Close CAPA
Ready to create/update file’s
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Practical approach: Read | Capture & Share: what is relevant for your organization
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• Prepare & Kick-off
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• Delta’s & Gap’s
Practical approach: Determine & Document Delta’s for your organization
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• Delta’s & Gap’s
Practical approach: Know the impact & who you need to close the gap’s
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• Business decision’s
Products Action focus
Gap’s Measuring
Chamber
Mammography
paddle
Collimator
Competences ++ - 0 2
Production +++ - + 1
Annex route + 3
Availability of
clinical data
0 - - -
Business
decision
Start redesign
project
No impact Stop
Practical approach: Summarize impact Decide: Products | NoBo | Extra resources needed
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• Close-gap’s
Practical approach: Cluster Delta’s in Gap’s& Document your approach: Plan Do Check Act
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• Close-gap’s
Practical approach: Log the statusImplement the created MDR templates & procedures for product(s)
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• Intern Audit
Practical approach: Plan an (External) Internal Audit on:MDR Readiness of QMS System & Updated Technical file
ISO 13485:2016 MDR 2017/745
For the Technical file which is strategically the most relevant (Update of new release expected)
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Finish
Close MDD to MDR Project: Goal Reached? MDR Compliant?
Transition period of 3 years
November 2017Apply for Designation by NoBo’s under MDR
Designation approx. 1.5y
26 May 2020Application of MDR
MDD certificate validity (4 years)
No more MDD devices on the market
26 May 2024Last MDD certificates expire
Today
Get MDR Ready Ready to apply
© 2016 Holland Innovative
Agenda
Status Check: where are you?
Determine your goal
Gap’s relevant for every economic operator
Plan of Action: an example Read Delta’s Cluster Close
When time is left: Challenging topics: Let’s learn from each other System Validation Equivalence ..
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© 2016 Holland Innovative
Challenging topics: System Validation
© 2016 Holland Innovative
Realistically: Equivalence can only be used when the complete Technical file is at the Company
Challenging topics: Equivalence
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© 2016 Holland Innovative
Thank you !
Success with your transition!
Contact us for support:
www.Holland-innovative.nl
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