The importance and value of IVD CE regulatory compliance ......unsafe medical and diagnostic devices...
Transcript of The importance and value of IVD CE regulatory compliance ......unsafe medical and diagnostic devices...
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
The importance and
value of IVD CE
regulatory compliance
for LCMS analysis
Denis Calnan
Clinical/Forensic Business
Specialist (Northern Europe)
Båstad Nordics Symposium 2011
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
Agenda
Waters Instruments available for Clinical Labs
Applications
IVD compliance
How the Waters Corp. achieves this
• Questions/ Discussion
©2011 Waters Corporation – COMPANY CONFIDENTIAL 3
About Waters
Milford, Massachusetts – Corporate Headquarters
Manchester, England – MS Technologies Centre
Facts and Figures
• $1.5 billion in annual revenue
• Direct sales/service in 97
offices serving 54 countries
worldwide
• 4,200 employees
FDA approved manufacturing site Wexford, Ireland
Demo Lab Waters Sverige AB Sollentuna
©2011 Waters Corporation – COMPANY CONFIDENTIAL 4
Our Capabilities
From LC …
… to total LC/MS solutions columns
sample preparation products
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Quality System Regulations
• Quality standards are designed to protect the public from unsafe medical and diagnostic devices
FDA published a quality system regulation in 1978. GMPs were revised by adding design control requirements that became effective in 1997
• Regulations are intended to ensure that finished devices will be safe and effective
Enhance consumer protection by reducing the number of recalls from poorly-designed devices and resultant patient harm/injuries
• Regulations apply to all device manufacturers
©2011 Waters Corporation – COMPANY CONFIDENTIAL 6
IVD-Labeled ProductsValue to Clinical Customers
What are the implications of a medical device (IVD label) designation on Waters products?
• Designates that Waters manufactures medical devices (not general laboratory or research use only devices)
• Signifies that the products have been designed, developed, and manufactured in accordance to and compliance with the Quality System Requirements (US) and In Vitro Diagnostics Directive (EU)
ISO 13485EU IVDD 98/79/EC
• The regulations are intended to provide the market with safe and effective products
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What is the value of a medical device (IVD) designation?
• Designates the medical device product can be promoted to and
used by clinical customers for diagnostic purposes (as opposed
to non-diagnostic or research use only purposes)
• Waters evaluates all field complaints, opens corrective and
preventative action (CAPA) to resolve issues in a timely
manner
IVD-Labeled ProductsValue to Clinical Customers
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How is medical device designation of value to the clinical
laboratory?
• Demonstrates that the vendor (Waters) is committed to
ensuring high quality products for clinical laboratories intended
to generate high quality patient results
IVD-Labeled ProductsValue to Clinical Customers
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
IVD-Labeled Products
• Waters are currently the only MS instrument company to manufacture to IVD CE certificated Standards.
• What are the implications of a medical device (IVD label) designation on Waters products?
• Designates that Waters manufactures medical devices
• Signifies that the products have been designed, developed, and manufactured in accordance to and compliance with the Quality System Requirements (US) and In Vitro Diagnostics Directive (EU)
• The regulations are intended to provide the market with safe and effective products
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What actually happens?
Instruments are separated during the manufacturing process, this
division into IVD and non-IVD instrument actually occurs at the QC
and testing phases where they are taken to two different areas of
the testing room.
Therefore the actual instrument assembly for both IVD and non-
IVD is the same high standard, this process is up to FDA standards
(and passed an FDA audit) for medical device manufacture.
©2011 Waters Corporation – COMPANY CONFIDENTIAL 11
What actually happens?
The real difference in our IVD and non-IVD instruments is
the further corrective and preventive actions steps we carry
out on the clinical systems and also the compliant handling
process.
This ensures that any identified faults (either reported to us
by a customer ie. clinical compliant or discovered by us) is
examined for risk to the patient results.
If the risk is deemed to be significant then a field service
action to repair (or prevent) the fault on all other clinical
systems in the field has to be done.
An example being the recent TQD probe upgrade
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
Instrument and Solutions Portfolio
• Xevo TQ and Xevo TQ-S
• High Sensitivity Analysis
• Challenging samples/matrices
• Lowest detection levels
• TQD
• Most popular , workhorse
instrument
IVD CE marked instruments
©2011 Waters Corporation – COMPANY CONFIDENTIAL 13
Introducing Acquity Online SPE Manager (OSM)
“A UPLC®-enabled online solid phase
extraction system”
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
Technical Files (‘IVD apps note’)- Waters IVD cleared solutions
• Clinical Diagnostics
TDM – Tacro/Evero
CAH panel
Plasma Metanephrines
Urinary free Cortisol
25-OH Vitamin D (D2 + D3)
• Clinical Toxicology
Tof and Triple Toxicology screening library applications
Opioid (morphine/heroin) dependency
Benzodiazepines
Psychotherapeutic Drugs
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
MassTrak Immunosuppressants XE IVD Kit
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
Product Definition
Waters MassTrak™
Immunosuppressants XE is a
reagent kit intended for in
vitro diagnostic (IVD) use for
the quantification of
immunosuppressant drugs
Everolimus and Tacrolimus
in laboratories by
professionally trained staff.
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
Labeling Claims
The MassTrak Immunosuppressants XE kit is CE markedand cleared for in vitro diagnostic use in Europe inaccordance with the IVDD Directive 98/79/EC.
IVDIVD
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MassTrak™ Immunosuppressants XE Kit
Calibrators
— Freeze-dried whole blood matrix
Quality controls
— (L, M & H)
Internal standards
— Isotopically labelled (deuterated) Everolimus
— Ascomycin (structural analogue of Tacrolimus)
Tuning mixture for instrument tuning
Waters cartridge column
— MassTrak™ TDM C18 cartridge column, 2.1 mm x 10 mm
Number of samples per kit
— 500 total tests including QC’s, calibrators, approximately 350 samples
Directions for Use
Certificate of Analysis
©2011 Waters Corporation – COMPANY CONFIDENTIAL 19
Directions for Use
Translated into 7 Languages
English
French
Italian
German
Spanish
Portuguese
Danish
©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation – COMPANY CONFIDENTIAL
Peer Reviewed Support…Gold Standard
Med Ed Tacro
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©2011 Waters Corporation – COMPANY CONFIDENTIAL 22
Quality Management Systems (QMS)
o GMP
o ISO 13485
Documentation
Performance Datao Accuracy
o Linearity
o Interference
Post Market Surveillance
Incident Reporting(MDR)
Risk Analysis
Labelling
Translate the Value Proposition to the Clinical Laboratory
Confidence in Product Quality
o Designed and developed under design control
o Consistent product quality
o Analytical performance verified / validated with documented test results
o Product and process risk assessments
o Complaint investigations & notification to customers
o Corrective and preventative action (CAPA) processes
o Precision
o Dilution
Stability
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Conclusions
Waters is offering:-
Single vendor complete solution
— An organisation that works to medical device regulations
o ISO 13485
o EU IVDD 98/79/EC
— Appropriate instrumentation for the applications
o TQD, Acquity UPLC, Xevo family
— A dedicated service organisation
— Extensive chemistry/consumables products for sample clean-up
— An applications support team that has developed and
implemented clinical/forensic applications around the world
o Strong publication record
— A decade of history with more than 1500 clinical installations