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


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


Our Capabilities

From LC …

… to total LC/MS solutions columns

sample preparation products


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


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


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



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 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


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.


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


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


Introducing Acquity Online SPE Manager (OSM)

“A UPLC®-enabled online solid phase

extraction system”


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


MassTrak Immunosuppressants XE IVD Kit


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.


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


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


Directions for Use

Translated into 7 Languages

English

French

Italian

German

Spanish

Portuguese

Danish


Peer Reviewed Support…Gold Standard

Med Ed Tacro


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


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

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