IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
TGA presentation: Postmarket MonitoringTGA Australia
View this presentation for information on:
what postmarket monitoring is and why it is important
tools used in postmarket monitoring, including risk management plans
managing risk and adverse events
the TGA's early warning system and recall actions.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
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.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
TGA presentation: Postmarket MonitoringTGA Australia
View this presentation for information on:
what postmarket monitoring is and why it is important
tools used in postmarket monitoring, including risk management plans
managing risk and adverse events
the TGA's early warning system and recall actions.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
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.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body which was set up in 2003 to bring together the functions of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor if the law has been broken. The regulations need to be robust enough to protect the public’s health, and this costs money. The MHRA is funded largely by public monies from government for the regulation of devices, and by fees from the pharmaceutical industry for the regulation of medicines.
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
An overview of supplying ‘unapproved’ therapeutic goods in clinical trials, Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) Schemes, TGA and Stakeholders Responsibilities, Safety reporting and other regulatory requirements, Clinical trials FAQs, and the Australian Clinical Trials Handbook update
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
View this presentation for information on:
* what postmarket monitoring is and why it is important
* tools used in postmarket monitoring, including risk management plans
* managing risk and adverse events
* the TGA's early warning system and recall actions.
Changes to the regulation of autologous cells and tissuesTGA Australia
Presentation provides an overview of the changes to the regulation of autologous HCT, inlcuding guidance on restrtictions to advertiisng content and the need to report advert events.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
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
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
An overview of supplying ‘unapproved’ therapeutic goods in clinical trials, Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) Schemes, TGA and Stakeholders Responsibilities, Safety reporting and other regulatory requirements, Clinical trials FAQs, and the Australian Clinical Trials Handbook update
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
View this presentation for information on:
* what postmarket monitoring is and why it is important
* tools used in postmarket monitoring, including risk management plans
* managing risk and adverse events
* the TGA's early warning system and recall actions.
Changes to the regulation of autologous cells and tissuesTGA Australia
Presentation provides an overview of the changes to the regulation of autologous HCT, inlcuding guidance on restrtictions to advertiisng content and the need to report advert events.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
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
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
USP 621 Allowable Adjustment to Chromatography HPLC MethodsSandy Simmons
Effective August 1st 2014, the United States Pharmacopoeia (USP) published the latest revision to General Chapter <621> mapping out the "allowable adjustments" that can be made to USP methods without having to re-validate these methods. Articles provided by industry leaders in separation sciences, pharmacology and chemistry.
INTELECTUALNESS
Intellectual property refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce.
Knobbe Martens’ patent attorneys Russell Jeide and Scott Cromar hosted a seminar series on intellectual property basics for Temecula’s business community. Entrepreneurs, investors, startups, inventors and anyone interested in learning how intellectual property and patents can help their business will benefit from this presentation.
Property is an external thing that can be owned or possessed. Property can be divided into two categories: tangible
and intangible. The word tangible refers to something that has a definable physical form that can be felt or
touched. The word intangible refers to something that cannot be perceived by the senses.
WTO was born on 1st January 1995 with main objective to improve the welfare of people of member countries.
Its main function is to ensure that trade flows as smoothly, predictably & freely as possible.
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
A Patent is an intellectual property right relating to inventions and is the grant of exclusive right, for limited period, provided by the Government to the patentee, in exchange of full disclosure of his invention, for excluding others, from making, using, selling, importing the patented product or process producing that product for those purposes.
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
mHealth Israel_EU MedTech and eHealth Regulatory FrameworkLevi Shapiro
Presentation by Hogan Lovells, EU MedTech and eHealth Regulatory Framework. Best practices and key changes in the European medtech regulatory environment, 2018.
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
Educo Life Science [gathering clinical evidence] [module 1]Ali Abu
The slide are solely prepared by Educo Life Science
Module 1 will cover the following:
Regulatory, guidance and standards for gathering medical device clinical evidence
>How does the regulation apply to gathering of clinical evidence
>What guidance and standard documents need to be followed when gathering clinical evidence
>Clinical evidence for different device classes and the procedures relative to each
>What data, when, why, and how
>Clinical definitions and terminology
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.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
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.
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.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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.
- 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
2. 2
DEVICES: PERSPECTIVE
• 500,000 + devices on market
• 1/25 has an implant
• £11 billion UK
• £200 million maintenance
• > £460 million negligence
3. 3
Directives for Medical Devices
3 Directives:
• Active Implantable Medical Devices (90/385/EEC)
Powered implants
• Medical Devices (93/42/EEC)
Most other devices
• In Vitro Diagnostics (98/79/EC)
In Vitro Diagnostic Products
4. Summary of Directives
• Single market provision, based on mutual recognition and
removal of national measures
• specify essential requirements
• introduce controls covering the safety, performance,
specification, design, manufacture and packaging of devices
• specify requirements for assessment of clinical investigation
protocols
5. Summary of Directives (Cont)
• specifies requirements for the evaluation of any adverse incidents
that occur (Vigilance)
• introduces a system of classifying devices, and applies a level of
control which is matched to the degree of risk inherent in the
device
• introduces the concept of Notified Bodies who check and verify
that manufacturers and devices meet the relevant requirements
• Introduces a system of registration of medical devices
6. Manufacturer
• Reviews and complies with relevant Essential Requirements
• Implements systems
• If applicable applies to Notified Body for Assessment, test
• Makes Declaration of Conformity
• If applicable registers product with relevant Competent Authority
• Applies the CE Marking
• Operates Post Market Surveillance and Vigilance
7. Notified Body
Pre Market :
• Assessment against the particular Annex(es)
for Specified Product Range
• Issues Annex Approval(s)
• Batch Review of Highest Risk IVD Products
Post Market :
• Ongoing Surveillance (if QA Annex)
• Approves Changes
• Co-Regulator
8. Competent Authority
Notified Bodies : Initial Designation
: Ongoing Surveillance
Pre Market : Registration
: Clinical Investigation
: Review of TSE Summary Reports
Post Market : Vigilance
Throughout : Enforcement
9. 9
Risk Classification
• Low Risk – Class I
Plasters, Walking Sticks, Wheelchairs, Stethoscopes, Medicine Spoons,
Administration Sets, Syringes, Re-usable Surgical Instruments
• Medium Risk – Class IIa and IIb
Needles, Dental Filling Materials, Contact Lenses and Solutions,
Diagnostic and Monitoring Equipment, Condoms, Infusion Pumps, Blood Bags,
Haemodialysis Concentrates, Hearing Aids, Ventilators, Incubators, Surgical
Lasers, Anaesthetic Machines, Nebulisers
• High Risk – Class III and active implantables
Pacemakers, Cochlear Implants, Breast Implants, Devices containing
Medicinal Substances, Devices containing Animal Materials, Cardiovascular and
Devices, Neurological Implants, Absorbable Sutures
10. 10
EU REGULATORY SYSTEM
compliance ERs
safety, performance Notified Body
• quality systems
• design dossier
• clinical data (literature, C/I)
accredit
audit
Competent
Authority
European market
post market surveillance
serious adverse events
investigation
action
12. Definition
“software… intended by the manufacturer to be used
for human beings for the purpose of:
•diagnosis, prevention, monitoring, treatment or
alleviation of disease,
•diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap,
•investigation, replacement or modification of the
anatomy or of a physiological process,
•control of conception….”
12
13. Apps
The words and phrases listed below are all likely to
contribute to a determination by the MHRA that the
app they were associated with is a medical device:
amplify analysis interpret
alarms calculates controls
converts detects diagnose
measures monitors
13
14. Apps (Cont)
Decision support or decision making software that applies
some form of automated reasoning, such as a simple
calculation, a decision support algorithm or a more complex
series of calculations, e.g. dose calculations, symptom
tracking, clinicians guides. These are the types of software
most likely to fall within the scope of the medical devices
directives.
This includes software which provides personalised guidance
based on information it has about a specific individual and
makes use of data entered by them, provided by point of care
devices or obtained via health records.
14
15. Apps (Cont)
Apps acting as accessories to medical devices such
as in the measurement of temperature, heart rate,
blood pressure and blood sugars could be a medical
device as are programmers for prosthetics.
Software that monitors a patient and collects
information entered by the user, measured
automatically by the app or collected by a point of
care device may qualify as a medical device if the
output affects the treatment of an individual.
15
16. Apps (Cont)
Software that provides general information but does
not provide personalised advice, although it may be
targeted to a particular user group, is unlikely to be
considered a medical device.
Software that is used to book an appointment,
request a prescription or have a virtual consultation is
also unlikely to be considered a medical device if it
only has an administrative function.
16
17. Apps (Cont)
Some decision support software may not be
considered to be a medical device if it exists only to
provide information to enable a healthcare
professional to make a clinical decision as they
ultimately rely on their knowledge. However, if the
software or app performs a calculation or interprets or
interpolates data and the healthcare professional
does not review the raw data, then this software may
be considered a medical device.
17
18. Validation and Verification
It is essential that appropriate validation and
verification activities are performed ie
Pre – clinical testing
Clinical Evaluation including, if necessary, clinical
investigations
18
19. 19
ESSENTIAL REQUIREMENTS
“the devices must be designed in such
a way that….they will not compromise
the clinical condition or SAFETY of
patients…...provided that any RISKS
which may be associated with their
use constitute acceptable RISKS
when weighed against the benefits…”
MDD: Annex 1
…..devices must achieve the performance
intended by the manufacturer…..
20. Classification
• All software is considered to be ‘active’
• Implementing rule 2.3 - Software, which drives a
device or influences the use of a device
automatically falls into the classification of that
device.
• Rule 9 - Active therapeutical devices are generally
Class IIa – however if potentially hazardous then
Class IIb.
20
21. Classification (Cont)
• Rule 10 - Active devices intended for diagnosis are
generally Class IIa – however if potentially
hazardous then Class IIb.
• Rule 12 - All other Active Devices are class I.
• Rule 14 - All devices used for contraception or the
prevention of the transmission of sexually
transmitted diseases are in Class IIb.
21
22. Post Market Surveillance
Manufacturers have a responsibility to implement an
effective post-market surveillance system to ensure
that any problems or risks associated with the use of
their device once freely marketed are identified early,
reported to competent authorities, and acted upon.
This is known as the
medical devices vigilance system.
22