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2011 Belgium 2013 The Netherlands 2016 Spain & Mexico 2017 QbD Software 2018 Colombia Sales office USA
+200 Employees +50 Clients
QbD Timeline
2019 France
Regulatory pathway for Medical Devices QbD Timeline 2019 2018 - - PowerPoint PPT Presentation
Regulatory pathway for Medical Devices QbD Timeline 2019 2018 - - PowerPoint PPT Presentation
Regulatory pathway for Medical Devices QbD Timeline 2019 2018 France 2017 Colombia 2016 QbD Sales office USA Spain Software 2013 & Mexico The Netherlands 2011 Belgium +200 Employees +50 Clients QbD Fields of action Regulatory
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QbD Fields of action
Validation Quality assurance Project management & support Regulatory affairs
expertises
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QbD client portfolio
Pharma Biotech Medical devices Cosmetics
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Steven Vinkx
Medical Device QA & regulatory project engineer
QMS implementation Certification regulatory strategy Project management Training
Lead auditor ISO13485:2016
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Medical Device Life Cycle
Ideation Design & Development Verification & Validation ISO 13485:2016 Design Transfer Device production Post Market
Design & Development
Design control
Manufacturing
Change Control
Feasibility
Regulatory approval
Research
Scope of regulatory compliance
Product registration process PMS
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Regulatory strategy
Intended use & risk
Three factors to determine go-to-market regulatory strategy
Intended market MD versus IVD
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Intended market
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Europe : CE marking
- marking
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Medical Device or In Vitro Diagnostic ?
intended by the manufacturer to be used … for human beings …. for medical purposes … does not achieve its principal intended action by pharmacological, immunological or metabolic means … in or on the human body, but which may be assisted in its function …
Medical Device Regulation
… medical device to be used in vitro for the examination of specimens, …. derived from the human body …. solely or principally for the purpose of providing information …..
In Vitro Diagnostic Regulation
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Medical Device or In Vitro Diagnostic ?
Origin of input data? MD or IVD ? -> can be both
Software Integral versus standalone
More devices / platforms than you might expect!
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Software - Medical Device or IVD ?
Algorithm that generates a risk score to trigger care processes based on respiratory rate, heart rate, blood pressure, …
1
medical purpose in vivo monitoring
MD
Bio-informatics intended to analyze sequencing data coming from patient cancer genomes.
2
allows detection of genome alteration supports diagnosis and treatment decisions
IVD
IVD input
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Software - Medical Device or IVD ?
Software to be used for hospital staff planning and invoicing
3
no medical purpose
Generic
Qualification & classification guideline – MDCG (11/2019)
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Risk based classification
FDA vs MDR/EU Based on intended use / claim Correlation claim versus risk Higher class for higher risks
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Europe : Transition to MDR
May 2021
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Key MDR changes
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Key MDR changes
UDI EUDAMED (postponed) Classification
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Impact of COVID-19 pandemic
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Requests for «exceptional use»
On case-by-case patient & MD basis (e.g. respiratory devices)
“Compassionate use”
Request for a derogation on conformity assessment of NEW
- Medical Devices & IVD’s
- For the purpose of multiple patients
- Under supervision of National Competent Authority (FAGG)
Derogation requests
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IVD Derogations
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IVD for Covid-19
SARS-CoV-2 Virus testing
Genetic material (PCR) Surface antigens Mostly automated Diagnosis & Treatment
Antibody testing
blablabla
Immune response Lower effectiveness & sensitivity Fast result Population Screening
Context & Intended purpose !
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MD (&PPE) Derogations
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More flexible regulatory approval
Medical Device Class Is (sterile)
Non-CE marked Surgical Masks are allowed under strict conditions
Availability only during crisis No use of regular distribution channels
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More flexible testing regime
Ideation Design & Development Verification & Validation ISO 13485:2016 Design Transfer Device production Post Market
Design & Development
Design control
Manufacturing
Change Control
Feasibility
Regulatory approval
Research
Scope of regulatory compliance
Product registration process PMS
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More flexible testing regime
Harmonized Standard
EN 14683
Design & Development Verification & Validation
Other standards also accepted
YY 0469:2011 and YY/T: 0969-2013 ASTM F2100 Alternative Testing Protocol
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Free ISO standards
https://www.iso.org/covid19
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Medical Device Life Cycle
Ideation Design & Development Verification & Validation ISO 13485:2016 Design Transfer Device production Post Market
Design & Development
Design control
Manufacturing
Change Control
Feasibility
Regulatory approval
Research
Scope of regulatory compliance
Product registration process PMS
Start in time ! Determine the applicable legislation Determine intended use & classification Implement lean & efficient QMS
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Thank you
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