This presentation provided an insight into the clinical evidence requirements for medical devices. It also gave information about the level of clinical evidence required for conformity assessment procedures and during application audits. Lastly, it outlined requirements to keep contemperaneous clinical evidence once a device is included in the ARTG.
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 3A - Medical Devices - Manufacturer's eviden...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: Session 3B: Medical devices (IVDs) - applica...TGA Australia
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
Device Sponsor Information Day: Session 4B: Medical Devices (IVDs) - applicat...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 5 - Post-market - Adverse events and monitor...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 5 - Post-market - Recalls and non-recall act...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 1 - Conformity AssessmentTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 3A - Medical Devices - Manufacturer's eviden...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: Session 3B: Medical devices (IVDs) - applica...TGA Australia
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
Device Sponsor Information Day: Session 4B: Medical Devices (IVDs) - applicat...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 5 - Post-market - Adverse events and monitor...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 5 - Post-market - Recalls and non-recall act...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 1 - Conformity AssessmentTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: 4A - Medical Devices - Audit assessmentsTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Presentation: Clinical Evidence GuidelinesTGA Australia
This presentation provided an insight into the publication of the clinical evidence guidelines and an overview of clinical evidence requirements for medical devices. It also gave information about the level of clinical evidence required and the reason this level of evidence is required. Finally this presentation covered common errors made with clinical evidence.
Sponsor Information and Training day Session A1 – Medical Devices: Efficient ...TGA Australia
Overview
Definitions
Regulatory framework
Mandatory and non-mandatory audits
Common issues and how to avoid them
One-page attachment to provide additional information with the application
TGA presentation: medical devices audit assessmentsTGA Australia
An overview of the medical devices audit assessment process, including explanation about the difference between Level 1 and Level 2 audits and the information sponsors are generally required to provide.
Presentation: Medical Devices: how to stay included workshop - Annual ReportsTGA Australia
Session 4: Annual Reports: This presentation discusses the requirements and importance of annual reports including information that is required by the TGA and recognising avoidable errors when writing an annual report.
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
Presentation: Recall of Therapeutic GoodsTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
Update on software as a medical device (SaMD)TGA Australia
This presentation will explore the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software will be discussed in relation to their likely classification as a medical device.
Presentation: Medical Devices: how to stay included workshop - Adverse event ...TGA Australia
This presentation discusses adverse event reporting including identification and reporting of adverse events, recognising avoidable errors and the difference in reporting requirements for SAS and clinical trial devices.
Devices Sponsor Information Day: 4A - Medical Devices - Audit assessmentsTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Presentation: Clinical Evidence GuidelinesTGA Australia
This presentation provided an insight into the publication of the clinical evidence guidelines and an overview of clinical evidence requirements for medical devices. It also gave information about the level of clinical evidence required and the reason this level of evidence is required. Finally this presentation covered common errors made with clinical evidence.
Sponsor Information and Training day Session A1 – Medical Devices: Efficient ...TGA Australia
Overview
Definitions
Regulatory framework
Mandatory and non-mandatory audits
Common issues and how to avoid them
One-page attachment to provide additional information with the application
TGA presentation: medical devices audit assessmentsTGA Australia
An overview of the medical devices audit assessment process, including explanation about the difference between Level 1 and Level 2 audits and the information sponsors are generally required to provide.
Presentation: Medical Devices: how to stay included workshop - Annual ReportsTGA Australia
Session 4: Annual Reports: This presentation discusses the requirements and importance of annual reports including information that is required by the TGA and recognising avoidable errors when writing an annual report.
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
Presentation: Recall of Therapeutic GoodsTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
Update on software as a medical device (SaMD)TGA Australia
This presentation will explore the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software will be discussed in relation to their likely classification as a medical device.
Presentation: Medical Devices: how to stay included workshop - Adverse event ...TGA Australia
This presentation discusses adverse event reporting including identification and reporting of adverse events, recognising avoidable errors and the difference in reporting requirements for SAS and clinical trial devices.
Exploring Relationship Between Risk & ComplianceComplianceTrack
• How to identify compliance risks in the business
• How to involve risk management in compliance management
• Integrating compliance risks with useful management tools
Certified Risk and Compliance Management Professional (CRCMP) Prep Course Pa...Compliance LLC
Certified Risk and Compliance Management Professional (CRCMP) Prep Course – Part A
First Certified Course
Certified Risk and Compliance Management Professional (CRMCP)
This course has been designed to provide with the knowledge and skills needed to understand and support regulatory compliance and enterprise wide risk management, and to promote best practices and international standards that align with business and regulatory requirements.
The course provides with the skills needed to pass the Certified Risk and Compliance Management Professional (CRCMP) exam.
This course is intended for professionals that want to understand risk and compliance and to work as risk and compliance officers. They will prove that they are qualified, when they pass the Certified Risk and Compliance Management Professional (CRCMP) exam.
This course is intended for employers demanding qualified risk and compliance professionals. The course is recommended for senior executives involved in risk and compliance.
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Security, Risk, Compliance & Controls - Cybersecurity Legal Framework in Hong...Amazon Web Services
This session will provide an update on considerations for FIs around security and controls, with specific focus on the recently published Comprehensive Guidance on Cybersecurity Controls Issued by Securities and Futures Commission (SFC). The session will then conclude with an introduction to compliance concepts in the Cloud Using Security by Design principles.
Clinical documentation for medical devices Arete-Zoe, LLC
Clinical documentation for medical devices
Medical Devices Regulation (EU) 2017/745
We prepare EU MDR-compliant clinical documentation for medical device manufacturers for submission to notified bodies and national regulatory authorities.
EU MDR-compliant clinical documentation (English, Czech):
- Clinical evaluation (plan, report)
- Post-Market Clinical Follow-Up, -
- PMCF (plan, report, study design)
- Post-Market Surveillance System (plan, report)
- Clinical investigation design to complement existing evidence
- Biological Evaluation
- Literature review
Consulting
- Strategy how to generate clinical evidence
- Design of PMCF studies and clinical investigations
Additional support:
- Clinical expert for multiple medical specialties
- Risk management specialist
- Technical documentation
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
Presentation: Roundtable discussion on clinical evidence reports - Requiremen...TGA Australia
This will be a practical discussion which will explore clinical evidence requirement in Australia, EU and China including considerations of how to develop CERs which meet the requirements of the various jurisdictions.
mHealth Israel_The New Regulatory Challenges in Europe The Clinical Evaluatio...Levi Shapiro
Presentation by Michael imhoff about the upcoming Medical Device Regulation (MDR) in the EU. Includeds compliance with the General Safety and Performance Requirements. Demonstration of conformity with the general safety
and performance requirements in clinical
evaluation. Clinical evaluation with evidence for safety
and performance of the medical device. Assessment of side effects and the acceptability of the risk-benefit-ratio, based on clinical data. MDR is not a health technology assessment for payers. Results of the clinical evaluation should be documented
in a clinical evaluation report (CER).
Importance of systematic literature search for clinical evaluation (CE) the s...PEPGRA Healthcare
The Clinical Evaluation Report (CER) comprises of three major parts that present complete clinicalevaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of the medical device along with compliance and experience records. The third part of the CER deals with the literature review of the clinical evaluation published on equivalent devices.
Visit : www.pepgra.com
A literature review may form the major source of clinical evidence
to validate the safety and performance of the established devices
in their commercialization approval process, where it may not be
feasible to conduct new clinical investigations on the device.
Where do clinical evaluation and clinical investigation intersectI3CGLOBAL
Clinical Evaluation is the process of collecting and assessing all clinical data related to a device and evaluating whether sufficient clinical evidence exists to support conformity with regulatory requirements. The clinical investigation is often the most important evidence needed to prove your medical device is ready for market.
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
Similar to Device Sponsor Information Day: Session 2: Clinical evidence - pre-market and post-market (20)
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Device Sponsor Information Day: Session 2: Clinical evidence - pre-market and post-market
1.
2. Clinical evidence – pre-market and post-market
Session Chair ―
Wendy-Jane Morrow
Chief Executive Officer, IVD Australia
Speakers / Panelists ―
Dr David Hau
Medical Officer, Therapeutic Goods Administration
Dr Chiyan Lau & Dr Louise Brightman
Medical Officer, Therapeutic Goods Administration
Tammy Ahmadzada
Consultant, Brandwood Biomedical
Hiram Chipperfield
Regulatory and Market Access Manager, Alere
3. Clinical evidence
Pre-market and post-market
Dr David Hau
Devices Clinical, Medical Devices Branch, TGA
Devices Sponsor Information Day 2015
15 October 2015
4. Outline
• Legislative basis
• Essential principles
• Clinical data
– Clinical investigation data
– Literature review
– Post-market data
• Common problems
• Questions
Clinical evidence - pre-market and post-market
5. Legislative basis
Therapeutic Goods Act 1989
• Essential principles
• Medical device standards
Therapeutic Goods (Medical Devices) Regulations 2002
• Essential principles
• Medical devices to which the clinical evaluation procedures must be
applied
• Clinical evaluation procedure
Clinical evidence - pre-market and post-market
6. Essential Principle 14 – Clinical Evidence
• Every medical device requires
clinical evidence, appropriate for
the use and classification of the
device
• Demonstrating that the device
complies with the applicable
provisions of the Essential
Principles
Clinical evidence - pre-market and post-market
7. Outline
• Legislative basis
• Essential principles
• Clinical data
– Clinical investigation data
– Literature review
– Post-market data
• Common problems
• Questions
Clinical evidence - pre-market and post-market
8. Essential Principles (EPs)
Use of medical devices not to compromise health
and safety
EP 1
Design and construction of medical devices to
conform with safety principles
EP 2
Medical devices to be suitable for intended purpose EP 3
Long-term safety EP 4
Benefits of medical devices to outweigh any
undesirable effects
EP 6
Labelling & Instructions for use EP 13
Clinical evidence - pre-market and post-market
9. Demonstrating compliance with EPs
• Clinical evaluation procedure
– Obtaining clinical data
– Clinical investigation data
– Literature review
– Evaluation of clinical data
Clinical evidence - pre-market and post-market
10. Demonstrating compliance with EPs – Medical
Device Standards
• Compliance with applicable medical device
standards is not required, but it is one way
to establish compliance with essential
principles
• The manufacturer must ensure that the
clinical data obtained takes account of any
medical device standard or conformity
assessment standard that may apply to the
device, e.g. ISO 5840: Cardiac valve
prostheses
• If an applicable device standard is not
followed, a justification would be necessary
Clinical evidence - pre-market and post-market
11. Outline
• Legislative basis
• Essential principles
• Clinical data
– Clinical investigation data
– Literature review
– Post-market data
• Common problems
• Questions
Clinical evidence - pre-market and post-market
12. Clinical investigation data
The manufacturer of a kind of medical
device must obtain clinical data in
relation to the device in the form of
either or both of the following:
• Clinical investigation data
• A literature review
• Full clinical study reports demonstrating safety and/or performance in the
intended use.
• Requires a written clinical expert report, with an adequate critical evaluation of
the data.
Clinical evidence - pre-market and post-market
13. Substantial equivalence
• Technical characteristics (e.g.
materials, design, specifications,
physicochemical properties,
critical performance
requirements, manufacturing
process)
• Biological characteristics
• Clinical use
• Clinical expert should justify why
each difference should not pose
any impact on safety and
performance.
• Non-clinical information should be
included.
Clinical evidence - pre-market and post-market
14. Literature review
• Documentation of search and selection
strategy – should be reproducible
• Adequacy of databases used
• Critical analysis and synthesis of data
retrieved
• Relate these data to the intended
purpose and safety profile of the device
• Include both positive and negative results
• Clinical expert should provide a critical
discussion of how safety and
performance of the subject device is
demonstrated
• Clinical expert should discuss substantial
equivalence if applicable
Clinical evidence - pre-market and post-market
15. Post-market data
• Particularly helpful where:
– Paucity of clinical studies
– Borderline clinical evidence in
other respects
– Devices where clinical studies
are few or rarely conducted
– Recertification – should
provide up-to-date adverse
event and complaint data for
world wide sales
• Any post-market data is of use to
the clinical assessor and should
be provided where possible
Clinical evidence - pre-market and post-market
16. Clinical expert
• ‘Expert’ in the relevant field
• Must be clinically qualified,
commensurate with the device and its
intended purpose
• Must provide critical evaluation of
totality of all clinical data (and also pre-
clinical data where applicable), to arrive
at a reasoned conclusion on the risk-
benefit profile of the device for the
intended use
Critique is important: not summarising with a perfunctory conclusion
Show how the data address performance and safety
Clinical evidence - pre-market and post-market
17. Manufacturer’s ongoing obligations
• Maintain appropriate records:
– Technical documentation
demonstrating compliance of the
device with the EPs
– Systematically review information
gained after the device was
supplied in Australia, including (but
not limited to):
Literature reviews
Device tracking and registration
registers
Clinical evidence - pre-market and post-market
18. Outline
• Legislative basis
• Essential principles
• Clinical data
– Clinical investigation data
– Literature review
– Post-market data
• Common problems
• Questions
Clinical evidence - pre-market and post-market
19. Common problems
• Absence of the required
components of the clinical
documentation
• Unclear intended purpose(s)
• Lack of provision of adequate
information to enable an
evaluator to reproduce the
literature search
– Includes lack of provision of
appendices listing included
and excluded articles with
justification
Clinical evidence - pre-market and post-market
20. Common problems
• Inclusion of additional papers at
the end of a literature search
from an unknown literature
search
• All included studies are not
critically analysed; there seems
to be an element of ‘cherry
picking’
• References to documents that
have not been submitted
• Submission of any or all
information that could possibly
be related to this device
Clinical evidence - pre-market and post-market
21. Common problems
• Little or no critical assessment of
the data presented:
– No discussion of relative
strengths of the data (e.g.
RCTs, case control studies,
case series)
– Not establishing the validity of
the data for other devices to
the device under assessment
(e.g. substantial equivalence)
– Lack of discussion of the
validity or otherwise of
outcome measures used
Clinical evidence - pre-market and post-market
22. Common problems
• Inappropriate selection of
clinical ‘experts’
• No post-market data in
cases where it is perfectly
possible to supply it
Clinical evidence - pre-market and post-market
23.
24. Agenda
Presented by
Tamkin (Tammy) Ahmadzada, Brandwood Biomedical
Can we rely on European Evidence?
What is Clinical Evidence Anyway?
Key Messages for any device
25. Can we rely on European Evidence?
1 http://www.health.gov.au/internet/main/publishing.nsf/Content/Expert-Review-of-Medicines-and-Medical-Devices-Regulation
27. Key Messages for any device
Scope Completeness
Balance Expertise
28. Define the Scope
What is the Device?
Design,
materials,
variants,
operation
Sterile/
non-sterile
Single
/multiple
use?
Intended
use, label
claims
Contra-
indications
31. Search Strategy Example
•e.g. PubMed, Google Scholar, etc.
Databases searched
•e.g. “Stent” AND “abdominal aortic aneurysm”
•Search filters: Review articles, studies published in the last 10 years, etc.
•Date of search
Search Terms
•Device application: abdominal aortic aneurysm stent (identification of equivalent
devices).
•Study size: e.g. multiple patients, case reports.
•Study population: human only or animal studies?
•Follow-up period: e.g. long-term follow-up (such as five or more years).
•Article language: English
…
Inclusion Criteria
•Stents for different intended purpose or extended claims, e.g. thoracic aortic aneurysm,
cerebral aneurysm.
•Applications contraindicated in the device IFU.
….
Exclusion Criteria
34. Expertise
An individual with clinical qualifications relevant to the device and its use,
who also has experience in the use of the device in a clinical setting.
• E.g. Qualified nurse for general
hospital disposable equipment.
• E.g. Cardiac physician for an
endovascular stent.
35. Key Messages for any device
Scope Completeness
Balance Expertise
37. Background
• All opinions are my own and do not represent the views
of my employer or the TGA
• Experience:
IVDs Inclusion submissions requiring
compilation of clinical evidence
39. Clinical Utility
• Usefulness of analyte or parameter in
clinical decision making
• Well established analytes:
• Stating that analyte is well
established is sufficient
• E.g. No need to summarise
usefulness of hCG in pregnancy
• New analytes or new clinical uses of
old analytes need evidence of clinical
utility or usefulness
Analytical
Performance
Clinical
Utility
Clinical
Performance
40. Analytical Performance
• Also termed “Product validation and
verification”
• Specimen type
• Accuracy
• Analytical sensitivity
• Analytical specificity
• Measuring range
• Etc..
Analytical
Performance
Clinical
Utility
Clinical
Performance
41. Clinical Performance
• The IVD's ability to correctly identify a
particular clinical condition
• For well established analytes, clinical
performance can be established from
analytical performance
• Comparison to approved IVD or
“Gold Standard”
• Characterised clinical specimens
typically required (not just spiked
specimens)
• Self-test/ point of care must
demonstrate clinical performance in
target setting
Analytical
Performance
Clinical
Utility
Clinical
Performance
42. Presentation of Clinical Evidence
Clinical
Utility
Clinical
Performance
Analytical
Performance
Clinical
Evaluation Report
Performance
Characterisation
• Technical File:
• Analytical performance/
performance characterisation
• Clinical evaluation report:
• Clinical Utility
• Clinical Performance
• Level of Detail
• Class 1 - Summary
• Class 2 - Summary
• Class 3 - Detailed
• Class 4 - Detailed + Raw/Line data
for clinical evidence
43. Tips
• Refer to Guidance - www.tga.gov.au
• Ensure that Manufacturer understands
Australian clinical evidence
requirements and can provide the
necessary data
• Read the letter requesting the clinical
information
• Work with manufacturers to make
clinical studies easy to understand
• Summaries of study reports can be
OK
44. Tips
• Including published studies can
significantly strengthen clinical
evidence
• Some well-established products may
not have clinical evidence available to
current expectations
• Identify potential gaps in clinical
evidence and develop justification
• Post-market data such as
complaints rates or quality
assurance (QAP) results can
provide clinical evidence