santiago de chile, may 9 – 12, 2006 maria judite neves mdeg, msog infarmed lisbon, portugal study...
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Santiago de Chile, May 9 – 12, 2006
Maria Judite Neves
MDEG, MSOGINFARMED
Lisbon, Portugal
Study Group 1
DEFINITION OF MEDICAL DEVICE
Santiago de Chile, May 9 – 12, 2006
MEDICAL DEVICEWhy a harmonized definition ?
GHTF/SG1/N29R16:2005
• Harmonized definition offers significant benefits to the manufacturer, user, patient or consumer and to Regulatory Authorities;
• Supports global convergence of regulatory systems;
• Decreases the cost of regulatory compliance;• Allows patients earlier access to new
technologies and treatments
Santiago de Chile, May 9 – 12, 2006
MEDICAL DEVICE Definition
which doesn’t achieve its primary
intended action in or on the human body by pharmacological,
immunological or metabolic means, but
which may be assisted in its
intended function by such means
GHTF/SG1/N29R16:2005
• Instrument• Apparatus• Implant• Machine• Appliance• Software• Material• Other similar or related
article
• Diagnosis• Prevention• Monitoring• Treatment • Alleviation• Compensation• Investigation, replacement,
modification, or support of the anatomy or of a physiological process
• Supporting or sustaining life• Control of conception• Disinfection of medical devices
disease/
injury
Santiago de Chile, May 9 – 12, 2006
Low Risk
Santiago de Chile, May 9 – 12, 2006
Low Risk
Santiago de Chile, May 9 – 12, 2006
Low Risk and
Reusable
Santiago de Chile, May 9 – 12, 2006
Low Risk and
Reusable
Santiago de Chile, May 9 – 12, 2006
Low Risk and
Sterile
Santiago de Chile, May 9 – 12, 2006
Low Risk with
Measure function
Santiago de Chile, May 9 – 12, 2006
Medium Risk
Santiago de Chile, May 9 – 12, 2006
Medium Risk
Santiago de Chile, May 9 – 12, 2006
Medium Risk
High Risk
Santiago de Chile, May 9 – 12, 2006
High Risk
Santiago de Chile, May 9 – 12, 2006
High Risk
Santiago de Chile, May 9 – 12, 2006
Custom made medical devices
Santiago de Chile, May 9 – 12, 2006
• Neurological Conditions• Ear, Nose & Throat
Disorders• Spinal Disorders• Spasticity• Chronic Pain• Diabetes Management
• Cardiac Arrhythmias• Heart Failure• Sudden Cardiac Death• Coronary Artery Disease• Heart Valve Disease• G/I Reflux• Incontinence• Peripheral Vascular Disease
Medical Device Technologies
Santiago de Chile, May 9 – 12, 2006
Santiago de Chile, May 9 – 12, 2006
New Medical Technologies
Minimally invasive surgeryHigh precision robotic surgery
TelemedicineTargeted drug delivery systems
Lab-on-a chipRegenerative MedicineIn-vivo nano-imaging
Cell therapiesArtificial Organs
Biological sciences
Materials sciences
Information
Technology
Imaging Technolog
y
Santiago de Chile, May 9 – 12, 2006
MD
MEDICAL DEVICEBorderline Issues
Other products
CosmeticsIndividual protection equipment
IVMD
Biocides Medicinal
products
Santiago de Chile, May 9 – 12, 2006
MD
MEDICAL DEVICEBorderline Issues
Is this product a medical device ?
• Medical purpose
• Principal intended action
Santiago de Chile, May 9 – 12, 2006
Analysing ToolsAnalysing Tools
• Labelling / Instruction for use• Technical documentation• Pre-clinical and clinical studies• Enquiries• Classification/Demarcation
guidelines
MEDICAL DEVICEBorderline Issues
Santiago de Chile, May 9 – 12, 2006
Low Risk
Medium Risk
High Risk
400.000 Medical Device Types 10.000 Families
MEDICAL DEVICE
Source, EUCOMED
Santiago de Chile, May 9 – 12, 2006
• Reagent• Reagent Product• Kit• Calibrator• Control Material
MEDICAL DEVICES DEFINITION includes devices for “In Vitro” examination
• Instrument• Apparatus• Equipment or system
Santiago de Chile, May 9 – 12, 2006
• … and sample collection, specimen receptacles and storage devices.
MEDICAL DEVICES DEFINITION includes devices for “In Vitro” examination
Santiago de Chile, May 9 – 12, 2006
...to provide information :• Concerning a physiological or pathological state;• Concerning a congenital abnormality;• To determine the safety and compatibility with potencial
recipients;• To monitor therapeutic measures
MEDICAL DEVICE DEFINITION includes devices for “In Vitro” examination
Santiago de Chile, May 9 – 12, 2006
Thank You
Santiago de Chile, May 9 – 12, 2006
Study Group 1
Essential Principlesof
Safety and Performanceof Medical Devices
M. GroppGHTF SG-1
AdvaMed, EucomedGuidant Corporation
Brussels, Belgium
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Only medical devices that are safe and perform asintended should be allowed in the market
Agree
Disagree
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Presentation overview
• Introduction
• Purpose
• Overview of main points of Essential Principles guidance document
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
http://www.ghtf.org/index.html
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Document history
“The GHTF has identified as a priority the need to harmonize essential safety and performance criteria for a medical device that allow the manufacturer to demonstrate its product is suitable for its intended use.
This goal was achieved through the publication of guidance on the subject entitled Essential Principles of Safety and Performance of Medical Devices (SG1/N020 of June 30, 1999) that applied to the majority of medical devices but not to in vitro diagnostic devices. …”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Document history
“…. This current document supersedes that earlier one. The major difference between them is the expanded scope; this document now includes medical devices for the in vitro examination of specimens derived from the human body.”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Rationale
“Consistent identification, selection and application of safety and performance principles to a medical device offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities since it allows its manufacturer to design, manufacture and demonstrate the device is suitable for its intended use. ...”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Rationale
“… Moreover, eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Scope
“This document applies to all products that fall within the definition of a medical device that appears within the GHTF document Information Document Concerning the Definition of the Term “Medical Device”, including those used for the in vitro examination of specimens derived from the human body.”
Santiago de Chile, May 9 – 12, 2006
SPECIFY DEVICE’S INTENDED USE
DEVICECLSSSIFICATION
IDENTIFY RELEVANT ESSENTIAL PRINCIPLES of
SAFETY & PERFORMANCE
DESIGN & MANUFACTURE DEVICE TOMEET ESSENTIAL PRINCIPLES
DEMONSTRATE COMPLIANCETHROUGH TESTING, MEETING
REQUIREMENTS OF STANDARDS, ORTHROUGH CLINICAL EVALUATION etc.
RISK ANALYSIS/MANAGEMENT
PLACE SAFE DEVICE ON THE MARKET
FULL TECHNICAL DOCUMENTATION
SUMMARISED TECHNICAL INFORMATION
ESSENTIAL PRINCIPLES of SAFETY & PERFORMANCE
LABELLING
GUIDANCE ON CLINICAL
EVALUATION
DEFINITION OF A MEDICAL DEVICE
RISK BASED CLASSIFICATIONRULES
SUMMARY TECHNICALFILE
ROLE OFSTANDARDS
What is neededto ensure
safety & performance?
How does the manufacturer
demonstrate conformity?
How does the manufacturer
demonstrate conformity?
What is amedical device?
MANUFACTURER’SPOST-MARKETSURVEILLANCE
VIGILANCEREPORTS
VERIFICATIONTHROUGH
INDEPENDENTAUDIT
(if required)
REGULATORY OVERSIGHTAND ENFORCEMENT
INTERNATIONALSTANDARDS
FIGURE 1: OVERVIEW OF STUDY GROUP 1 WORK PROGRAMME
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Source: GHTF
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Purpose
“To describe six general requirements of safety and performance that apply to all medical devices.
To provide a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant to each medical device. …” [emphasis in original]
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Purpose
“… These are grouped as:
• Chemical, physical and biological properties
• Infection and microbial contamination
• Manufacturing and environmental properties
• Devices with a diagnostic or measuring function
• Protection against radiation
• Requirements for medical devices connected to or equipped with an energy source
• Protection against mechanical risks …
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Purpose
“… These are grouped as: (continued)
• Protection against the risks posed to the patient by supplied energy or substances
• Protection against the risks posed to the patient for devices for self-testing or self-administration
• Information supplied by the manufacturer
• Performance evaluation including, where appropriate, clinical evaluation”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Purpose
“The manufacturer selects which of the design and manufacturing requirements are relevant to a particular medical device, documenting the reasons for excluding the others.
The Regulatory Authority and/or Conformity Assessment Body may verify this decision during the conformity assessment process.” (or audit)
Santiago de Chile, May 9 – 12, 2006
SPECIFY DEVICE’S INTENDED USE
DEVICECLSSSIFICATION
IDENTIFY RELEVANT ESSENTIAL PRINCIPLES of
SAFETY & PERFORMANCE
DESIGN & MANUFACTURE DEVICE TOMEET ESSENTIAL PRINCIPLES
DEMONSTRATE COMPLIANCETHROUGH TESTING, MEETING
REQUIREMENTS OF STANDARDS, ORTHROUGH CLINICAL EVALUATION etc.
RISK ANALYSIS/MANAGEMENT
PLACE SAFE DEVICE ON THE MARKET
FULL TECHNICAL DOCUMENTATION
SUMMARISED TECHNICAL INFORMATION
ESSENTIAL PRINCIPLES of SAFETY & PERFORMANCE
LABELLING
GUIDANCE ON CLINICAL
EVALUATION
DEFINITION OF A MEDICAL DEVICE
RISK BASED CLASSIFICATIONRULES
SUMMARY TECHNICALFILE
ROLE OFSTANDARDS
What is neededto ensure
safety & performance?
How does the manufacturer
demonstrate conformity?
How does the manufacturer
demonstrate conformity?
What is amedical device?
MANUFACTURER’SPOST-MARKETSURVEILLANCE
VIGILANCEREPORTS
VERIFICATIONTHROUGH
INDEPENDENTAUDIT
(if required)
REGULATORY OVERSIGHTAND ENFORCEMENT
INTERNATIONALSTANDARDS
FIGURE 1: OVERVIEW OF STUDY GROUP 1 WORK PROGRAMME
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Source: GHTF
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 1
“Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training of intended users, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, …”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 1 (continued)
“… provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 2
“The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art.
When risk reduction is required, the manufacturer should control the risk(s) so that the residual risk(s) associated with each hazard is judged acceptable. …”
Reference: ISO 14971:2001: Medical devices – Application of risk management to medical devices
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 2 (continued)
“The manufacturer should apply the following principles in the priority order listed:
• identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse,
• eliminate risks as far as reasonably practicable through inherently safe design and manufacture
• reduce as far as is reasonably practicable the remaining risks by taking adequate protection measures, including alarms,
• inform users of any residual risks”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 3
“Devices should achieve the performance intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions within the scope of the definition of a medical device applicable in each jurisdiction.”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 4
“The characteristics and performances …. should not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 5
“The devices should be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected under transport and storage conditions (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer.”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
General requirement 6
“The benefits must be determined to outweigh any undesirable side effects for the performances intended”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Conformity assessment
“Refer to … Principles of Conformity Assessment for Medical Devices and the work of GHTF Study Group 5 for further information on the use of clinical evaluation to demonstrate compliance with these Essential Principles.”
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Summary
• Essential Principles form foundation of harmonised global regulatory model
• Comprehensive in scope
• Cover safety and performance
• Define design requirements
• Do not define methods of achieving, demonstrating, or documenting conformity
• Often covered by international standards
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Summary
• Flexible to accommodate advances in the state of the art and new medical devices / technologies / intended uses
• Recognise risks and benefits associated with medical devices
• Are founded on risk management principles
• Intimately linked to manufacturer’s quality system for design, manufacture, and risk management
Santiago de Chile, May 9 – 12, 2006
GHTF SG-1: Essential Principles of Safety and Performance of Medical Devices
Questions?
Peter W.J. LindersGHTF SG-1
COCIRPhilips Medical Systems
Best, The Netherlands
Study Group 1
STED
Summary Technical Documentation
Santiago de Chile, May 9 – 12, 2006
STED
What is STED ? How is STED developed ? What’s in STED ? Use of standards (brief)
Inspired by Johan Brinch & Ed Woo, APEC Bangkok 2005
Santiago de Chile, May 9 – 12, 2006
STED
STED=Summary Technical Documentation
Used for demonstrating conformity to the Essential Principles of …
Safety & Performance of Medical Devices
STED=information considered sufficient for regulatory agency to confirm conformity
Santiago de Chile, May 9 – 12, 2006
STED
Remember, STED is a
Summary Technical Documentation,
not …
Santiago de Chile, May 9 – 12, 2006
STED
GHTF identified the need to harmonize documentation
of evidence of conformity to regulatory requirements
MD manufacturers increasingly global Differences in documentation requirements
Necessitate additional work for the same device Hinder timely access to medical devices May pose barriers between countries Increase cost
International standardization good for all parties
Santiago de Chile, May 9 – 12, 2006
STED SPECIFY DEVICE’S INTENDED USE
DEVICECLSSSIFICATION
IDENTIFY RELEVANT ESSENTIAL PRINCIPLES of
SAFETY & PERFORMANCE
DESIGN & MANUFACTURE DEVICE TOMEET ESSENTIAL PRINCIPLES
DEMONSTRATE COMPLIANCETHROUGH TESTING, MEETING
REQUIREMENTS OF STANDARDS, ORTHROUGH CLINICAL EVALUATION etc.
RISK ANALYSIS/MANAGEMENT
PLACE SAFE DEVICE ON THE MARKET
FULL TECHNICAL DOCUMENTATION
SUMMARISED TECHNICAL INFORMATION
MANUFACTURER’SPOST-MARKETSURVEILLANCE
VIGILANCEREPORTS
VERIFICATIONTHROUGH
INDEPENDENTAUDIT
(if required)
REGULATORY OVERSIGHTAND ENFORCEMENT
Source: GHTF website (amended)
Global Regulatory Model
SUMMARISED TECHNICAL INFORMATION
Santiago de Chile, May 9 – 12, 2006
STED
Global Regulatory Model
FULL TECHNICAL DOCUMENTATION
SUMMARISED TECHNICAL INFORMATION
PLACE SAFE DEVICE ON THE MARKET
Zoom-in on essential part …
Santiago de Chile, May 9 – 12, 2006
STED
Quality System Audit
Quality System
PostmarketvigilancePre-market approval
DesignVerification/Validation Manufacture Market
Harmonised Regulatory Model
SUMMARY TECHNICAL DOCUMENTATION
Santiago de Chile, May 9 – 12, 2006
STEDDesign Control Waterfall ModelQUALITY SYSTEM DESIGN PROCESS GUIDELINE
Technical
Requirements
Device
Description
Verification and
Validation
Documents
Production,
Process &
Other docs.
PROCESS OUTPUTS
Santiago de Chile, May 9 – 12, 2006
STEDSource and Application
QUALITY SYSTEM OUTPUT SUMMARY DOCUMENTATION USAGE
Technical
Requirements
Device
Description
Verification &Validation
Documents
Production,Process & Other docs.
DataSubset
Summary
Technical Documents
DataSubset
DataSubset
DataSubset
Pre-market
Submitted
and/or
on file
Post-market
Available
for audit
Santiago de Chile, May 9 – 12, 2006
STEDSummary Technical Documentation
Device description
Essential Principles: evidence of conformity
Labelling
Risk analysis (risk management)
(pre-)clinical design verification & validation
Manufacturing information
Santiago de Chile, May 9 – 12, 2006
STEDDetail of the Contents of Data
Novelty of Medical Device
Class D Ⅳ( )Class C Ⅲ( )Class B Ⅱ( )
Require Clinical data
Assess the Conformity to Standards
Assess Validity and Safety from the Examination Results etc.
STED & amount of information
Santiago de Chile, May 9 – 12, 2006
STED
Again, STED is a
Summary Technical Documentation,
not …
Santiago de Chile, May 9 – 12, 2006
STEDDevice description
7.2 Device description functional purpose general description of the device the intended patient population(s) contraindications an explanation of any novel features the accessories the variants of the device comparisons to other devices
Santiago de Chile, May 9 – 12, 2006
STED Device description (2)
materials and their physical properties
functional characteristics
technical performance specifications
chemical, physical, electrical, mechanical, biological, software, sterility, stability, storage and transport, and packaging
Santiago de Chile, May 9 – 12, 2006
STEDEssential Principles and evidence
of conformity
7.1 Essential Principles
For ease of use in a global situation, it is recommended that the evidence of conformity be provided in tabular form with supporting documentation available for review as required
Santiago de Chile, May 9 – 12, 2006
STED Essential principles checklist
Santiago de Chile, May 9 – 12, 2006
STEDLabelling
7.4 Labelling
Labels on the device and its packaging
Instructions for use
Other literature or training materials
Instructions for installation and maintenance
Any information and instructions given to the patient, incl. instructions for any procedure the patient is expected to perform
Santiago de Chile, May 9 – 12, 2006
STED
Risk analysis
7.5 Risk analysis
The STED should summarize or reference or contain (as determined by need for a submission and the option selected by the manufacturer in Section 6.2) the results of the risk analysis. This risk analysis should be based upon international or other recognized standards, and be appropriate to the complexity and risk class of the device.
Santiago de Chile, May 9 – 12, 2006
STED
Risk analysis
Can you have full Risk Analysis (or Risk Management) details in STED ???
Santiago de Chile, May 9 – 12, 2006
STED
Risk analysis
• Risk analysis/mgt dossier is BIG• No prescribed format• Links to many other documents• Decisions made by manufacturer• (How to) interpret all information?
Santiago de Chile, May 9 – 12, 2006
STED
Risk analysis
For the manufacturer • Include process description in STED dossier• Give actual RM process data for the device
For the regulator• Verify that RM process IS in place
Santiago de Chile, May 9 – 12, 2006
STED
Risk analysis
For the manufacturer • Include process description in STED dossier• Give actual RM process data for the device
For the regulator• Verify that RM process IS in place
Santiago de Chile, May 9 – 12, 2006
STED
Summary documents of pre-clinical design verification and validation
7.3.1 General on design V&V
declarations/certificates of conformity to the “recognized” standards listed as applied by the manufacturer and/or …
summaries or reports of tests and evaluations based on other standards, manufacturer methods and tests, or alternative ways of demonstrating compliance
Santiago de Chile, May 9 – 12, 2006
STED
engineering tests
laboratory tests
biocompatibility tests
animal tests
simulated use
software validation
Summary documents of pre-clinical design verification and validation
Santiago de Chile, May 9 – 12, 2006
STED
7.3.2 Clinical Evidence
The STED should indicate how any applicable requirements of the Essential Principles for clinical evaluation of the device have been met. Where applicable, this evaluation may take the form of a systematic review of existing bibliography, clinical experience with the same or similar devices, or by clinical investigation
Summary documents of (pre-)clinical design verification and validation
Santiago de Chile, May 9 – 12, 2006
STED
Manufacturing information
7.6 Manufacturer information
The STED should summarize or reference or contain documentation related to the manufacturing processes, including quality assurance measures, which is appropriate to the complexity and risk class of the device
Santiago de Chile, May 9 – 12, 2006
STED
From 2.0: Regional tailoring
As an interim measure until full global harmonization of documentation requirements is achieved, the precise content of the STED … will need to be augmented by documentation required by country-specific regulations and regulatory guidance
USA - FDA / Canada - HC / Europe - NB’s /
Australia - TGA / Japan - MHLW / other - ?
Regional tailoring
Santiago de Chile, May 9 – 12, 2006
STED
USA - FDA / Canada - HC / Europe - NB’s /
Australia - TGA / Japan - MHLW / other - ?
FDA: http://www.fda.gov/cdrh/ode/guidance/1347.html HC: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/ghtffs_gthmfd_e.html
http://www.asiahwp.org/Canada_ghtf_sted_guide_e.pdf
EU: no format specified
TGA: http://tga.health.gov.au/docs/pdf/tganws/tganews35.pdf
MHLW: no specific url available
Regional tailoring
Santiago de Chile, May 9 – 12, 2006
STED
Philips CT STED Outline
COVER LETTER TO ODE a) Introduction, rational, and confidentiality b) Device Trade Name & Classification Name c) Establishment Registration number & address d) FDA Device Classification per 21 CFR 892 e) Philips CT contact information
TABLE OF CONTENTS
a) Safety & Effectiveness Summary/Statement, per 21 CFR 807.87(h), Attachment “A” b) Truthful & Accurate Statement per 21 CFR 807.87(k), Attachment
“B” c) Indications for Use, Attachment “C” d) Table of Essential Principles & Evidence of Conformity, Attachment
“D”
Essential Principle
Applicability to Device
Method of Conformity
Identity of Specific Documents
e) Risk Management File in Attachment “E”:
f) “Summary” of design (hardware & software) verification/validation
includes the “level of concern for software”, may include the following in Attachment “F”:
1. Performance tests if applicable 2. Biocompatibility of patient contact materials
g) Labeling: includes the Operator Instruction (preliminary) with maintenance schedule, Product Data/Brochure, predicate device comparison matrix, may include identification labels, pictures or drawings of product, accessory information, predicate brochures and installation instructions in Attachment “G”.
Santiago de Chile, May 9 – 12, 2006
STED
Philips CT STED Outline
COVER LETTER TO ODE a) Introduction, rational, and confidentiality b) Device Trade Name & Classification Name c) Establishment Registration number & address d) FDA Device Classification per 21 CFR 892 e) Philips CT contact information
TABLE OF CONTENTS
a) Safety & Effectiveness Summary/Statement, per 21 CFR 807.87(h), Attachment “A” b) Truthful & Accurate Statement per 21 CFR 807.87(k), Attachment
“B” c) Indications for Use, Attachment “C” d) Table of Essential Principles & Evidence of Conformity, Attachment
“D”
Essential Principle
Applicability to Device
Method of Conformity
Identity of Specific Documents
e) Risk Management File in Attachment “E”:
f) “Summary” of design (hardware & software) verification/validation
includes the “level of concern for software”, may include the following in Attachment “F”:
1. Performance tests if applicable 2. Biocompatibility of patient contact materials
g) Labeling: includes the Operator Instruction (preliminary) with maintenance schedule, Product Data/Brochure, predicate device comparison matrix, may include identification labels, pictures or drawings of product, accessory information, predicate brochures and installation instructions in Attachment “G”.
Santiago de Chile, May 9 – 12, 2006
STED
USA - FDA / Canada - HC / Europe - NB’s /
Australia - TGA / Japan - MHLW / other - ?
Regulators and industry should jointly evaluate
progress towards harmonization and
adapt processes accordingly:
“continual improvement”
Regional tailoring
Santiago de Chile, May 9 – 12, 2006
STED
Santiago de Chile, May 9 – 12, 2006
Building blocks for harmonized regulatory processes
International Standards
Santiago de Chile, May 9 – 12, 2006
Use of Standards in conformity assessment(another GHTF SG1 document)
• Compliance to “Recognized Standard” gives• “Presumption of compliance” with Essential
Principles• Voluntary except when deemed mandatory• Manufacturer is free to select alternative
solutions to demonstrate compliance– National and International standards– Industry standards– Internal SOP– Current state of art techniques related to
performance, material, design, processes
Santiago de Chile, May 9 – 12, 2006
Standards in STED
• In STED, in lieu of technical doc. submission• Declarations, certificates, summary test
report• Retain documentation to demonstrate
device compliance to selected standard or other means to meet Essential Principles– How standard was applied with test results.– Deviations
• other means to compliance• when not applicable
Santiago de Chile, May 9 – 12, 2006
Standards in development
• ISO, IEC, … are global bodies• Use defined consensus mechanism• All stakeholders involved• Stepwise development process:
NWIP / CD / CDV or DIS / FDIS / IS• Maturation process, usually > 3 years• Voting process includes national
committees• Great help in global convergence !!
Santiago de Chile, May 9 – 12, 2006
Standards in development
A few well known examples:
• ISO 13485: Quality Mgt. System for medical device manufacturers
• ISO 14971: Risk Mgt. for medical devices
• IEC 60601-1: Safety & Essential Performance for medical electrical equipment
Santiago de Chile, May 9 – 12, 2006
Revision or Replacement of Recognized Standards
• Updated standard becomes “recognized” too• Transition Period
– Should allow for manufactures to implement– Max < 5 years; unless exceptional circumstances
• During Transition Period– Both versions give presumption of conformity to EP– Unless safety implication, devices on market is OK
• After Transition Period– Superseded document may be withdrawn– Manufacturer using superseded version may do so
but should perform & document risk assessment on differences
Santiago de Chile, May 9 – 12, 2006
Summary on standards
• Standards compliance is one means to demonstrate compliance to Essential Principles
• Transition to revised version important• Standards enforcement flexibility should be
allowed• International standards key in harmonization• Economies may want better participation in
development and use of international standards
Santiago de Chile, May 9 – 12, 2006
STED
Final comments STED is a compilation of a subset of
documents normally generated during the design process
Size of the STED dossier is proportional to the risk class of the device
Some regional tailoring is still here …
Santiago de Chile, May 9 – 12, 2006
STED