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Copyright Qserve Group B.V. 1
A global leading medical device consultancy group
IVDR The Executive Summary
Sue SpencerHead of IVD at QServe
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3 Key things you need to know about the IVDR
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P a g e 5 | C o p y r i g h t Q s e r v e G r o u p B . V .
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
IVDD certificate
IVDD certs void May 27 2024
Renewal
Transition period Soft transition - grace
IVDR certificate
Entry into force25-5-2017
Date of Application, (DoA)
May 26, 2022
IVDD Annex II List A effective transition period
IVDD Self declared effective transition period
IVDD Annex II List A + B + Self test effective transition period
Transitioning details – IVDRWe are here
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Implementation Status
15%• Not started
75% • Creating gap analysis and reviewing product portfolio
10%• Prepared initial pilot TFs + implementing new
procedures for the QMS
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IVDR implementation activities
•QMS•Technical file
preparation
•Internal audits•Mock audits•Notified Body audits
and assessments
•Clinical•Supply chain•Notified Bodies
•Technical File•QMS•Portfolio assessment
GAPImplement time-critical
elements
Implement full plan
Verification
Finetuning Improvement
corp
orate
BUs
Core team
training
coordination
monitoring
balancing
alignment
meetings
communication
Steering Committee
Program Management
Taskforces, BUs
Includes RoW registrations as input to rationalization decisions
2022
2021
2019-2021
2017-2018
2019
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Feedback from the field
Feedback from those who have done a gap analysis revealed some common gaps• Stability• Review of stability data often finds missing time points to support current
expiry dates • It will take time to create fresh data
• Clinical evidence• New reports required• Often analytical but insufficient clinical performance data
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Clinical Evidence
'clinical evidence' means the clinical data and performance evaluation results, pertaining to a device of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturerDocumented in a Performance Evaluation Report
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Clinical Evidence
• Scientific validity of an analyte means the association of an analyte to a clinical condition or a physiological state;
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• Analytical performance means the ability of a device to correctly detect or measure a particular analyte
• Clinical performance means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user
Clinical utility not required
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The devil is in the detail
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Prescriptive detail
• Performance evaluation plan,• Performance study plan• Clinical performance study plan• Post-market surveillance plan• Post Market performance follow-
up Plan• Risk management Plan• Corrective and preventive action
plan
• Performance evaluation report• Performance study report• Post-market surveillance report• Scientific validity report• Analytical performance report• Clinical performance report• Complaint report• Vigilance report• Trend report• Periodic safety update report
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Continuous
Performance Evaluation Report
Scientific validity
Analytical performance
Clinical performance
Post market surveillance process
PMS Plan
Analysis of data
PMS report
Risk management
Corrective action
Preventive action
Product specification and performance to be maintained
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Resource
Resource
Time
• Extra work to create and maintain new IVDR Plans and reports
• Not all the extra resource required will come from Regulatory and Quality
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Finally…..
• IVDR will be subject to revision through implementing acts• Expectations are likely to increase with experience• Approval times will increase and will need to be factored into design
programs• Whilst there will be a bolus of activity to achieve compliance to the
IVDR significant effort will be required to continue to meet the requirements and maintain the system• Planning ahead and keeping on top of forthcoming changes will be
essential to staying ahead in the future
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Thank you for your attention
Copyright Qserve Group B.V.
Sue SpencerIVDR The Executive Summary
