Santiago de Chile, May 9 – 12, 2006 Maria Judite Neves MDEG, MSOG INFARMED Lisbon, Portugal Study...

Santiago de Chile, May 9 – 12, 2006

Maria Judite Neves

MDEG, MSOGINFARMED

Lisbon, Portugal

Study Group 1

DEFINITION OF MEDICAL DEVICE

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

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

Low Risk

Low Risk and

Reusable

Low Risk and

Reusable

Low Risk and

Sterile

Low Risk with

Measure function

Medium Risk

High Risk

Custom made medical devices

• 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

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

MEDICAL DEVICEBorderline Issues

Other products

CosmeticsIndividual protection equipment

Biocides Medicinal

products

Is this product a medical device ?

• Medical purpose

• Principal intended action

Analysing ToolsAnalysing Tools

• Labelling / Instruction for use• Technical documentation• Pre-clinical and clinical studies• Enquiries• Classification/Demarcation

guidelines

Low Risk

Medium Risk

High Risk

400.000 Medical Device Types 10.000 Families

MEDICAL DEVICE

Source, EUCOMED

• Reagent• Reagent Product• Kit• Calibrator• Control Material

MEDICAL DEVICES DEFINITION includes devices for “In Vitro” examination

• Instrument• Apparatus• Equipment or system

• … and sample collection, specimen receptacles and storage devices.

MEDICAL DEVICES DEFINITION includes devices for “In Vitro” examination

...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

Thank You

Study Group 1

Essential Principlesof

Safety and Performanceof Medical Devices

M. GroppGHTF SG-1

AdvaMed, EucomedGuidant Corporation

Brussels, Belgium

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

Disagree

Presentation overview

• Introduction

• Purpose

• Overview of main points of Essential Principles guidance document

http://www.ghtf.org/index.html

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. …”

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.”

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. ...”

Rationale

“… Moreover, eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.”

“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.”

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?

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

Source: GHTF

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]

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 …

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”

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)

SPECIFY DEVICE’S INTENDED USE

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?

What is amedical device?

VIGILANCEREPORTS

VERIFICATIONTHROUGH

INDEPENDENTAUDIT

(if required)

INTERNATIONALSTANDARDS

FIGURE 1: OVERVIEW OF STUDY GROUP 1 WORK PROGRAMME

Source: GHTF

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, …”

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.”

“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

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”

“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.”

“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.”

“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.”

“The benefits must be determined to outweigh any undesirable side effects for the performances intended”

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.”

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

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

Questions?

Peter W.J. LindersGHTF SG-1

COCIRPhilips Medical Systems

Best, The Netherlands

Study Group 1

Summary Technical Documentation

What is STED ? How is STED developed ? What’s in STED ? Use of standards (brief)

Inspired by Johan Brinch & Ed Woo, APEC Bangkok 2005

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

Remember, STED is a

Summary Technical Documentation,

not …

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

STED SPECIFY DEVICE’S INTENDED USE

VIGILANCEREPORTS

VERIFICATIONTHROUGH

INDEPENDENTAUDIT

(if required)

Source: GHTF website (amended)

Global Regulatory Model

Zoom-in on essential part …

Quality System Audit

Quality System

PostmarketvigilancePre-market approval

DesignVerification/Validation Manufacture Market

Harmonised Regulatory Model

SUMMARY TECHNICAL DOCUMENTATION

STEDDesign Control Waterfall ModelQUALITY SYSTEM DESIGN PROCESS GUIDELINE

Technical

Requirements

Device

Description

Verification and

Validation

Documents

Production,

Process &

Other docs.

PROCESS OUTPUTS

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

Pre-market

Submitted

and/or

on file

Post-market

Available

for audit

STEDSummary Technical Documentation

Device description

Essential Principles: evidence of conformity

Labelling

Risk analysis (risk management)

(pre-)clinical design verification & validation

Manufacturing information

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

Again, STED is a

Summary Technical Documentation,

not …

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

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

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

STED Essential principles checklist

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

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.

Risk analysis

Can you have full Risk Analysis (or Risk Management) details in 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?

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

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

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

engineering tests

laboratory tests

biocompatibility tests

animal tests

simulated use

software validation

Summary documents of pre-clinical design verification and validation

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

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

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

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

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”.

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”.

Regulators and industry should jointly evaluate

progress towards harmonization and

adapt processes accordingly:

“continual improvement”

Regional tailoring

Building blocks for harmonized regulatory processes

International Standards

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

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

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 !!

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

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

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

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 Maria Judite Neves MDEG, MSOG INFARMED Lisbon, Portugal Study...

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