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Medical Device Definition

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Nealda Yusof
Nealda Yusof

This 10-minute lecture gives a step-by-step instruction on medical device definition. It covers the basic definition of a medical device, its key attributes, and intended purpose. A brief insight is provided into in vitro diagnostic medical devices. At the end of this lecture, the student will be able to differentiate a medical device from pharmaceutical and biological healthcare products. The student will also be able to decide whether a particular healthcare product comes under the definition of a medical device. http://semoegy.com

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Copyright © Semoegy Advisers & Ventures 1 WELCOME TO SEMOEGY LEARNING
Copyright © Semoegy Advisers & Ventures 2 medical technology Education Knowledge Information Resource i
Copyright © Semoegy Advisers & Ventures 3
SEMOEGY LEARNING For Medical Technology Education, Knowledge & Information Resource MEDICAL DEVICE DEFINITION What is a Medical Device? Copyright © Semoegy Advisers & Ventures
COURSE CONTENT • Basic definition of a medical device • Key attributes • Intended purpose • Brief insight into in vitro diagnostic medical device Copyright © Semoegy Advisers & Ventures 5
DRUGS / PHARMACEUTICALS Copyright © Semoegy Advisers & Ventures 6 HEALTHCARE PRODUCTS MEDICAL DEVICES BIOLOGICS
Healthcare is one of the most regulated industries in the world Copyright © Semoegy Advisers & Ventures 7 HEALTHCARE PRODUCTS Medical devices are highly regulated
HEALTH PRODUCTS REGULATION Copyright © Semoegy Advisers & Ventures 8 REVIEW Approval of healthcare products before marketing RISK OF HARM Healthcare products may carry a certain risk of harm to patients EVIDENCE-BASED Associated risks must be reduced or eliminated
KEY INFLUENCER REGULATORS Copyright © Semoegy Advisers & Ventures 9 The European Union Directives for Medical Devices and Medicines Health Canada UNITED STATES CANADA The Medicines and Healthcare Products Regulatory Agency of the UK US Food & Drug Administration AUSTRALIA Therapeutic Goods Administration EUROPEAN UNIONUNITED KINGDOM
KEY INFLUENCER REGULATORS Copyright © Semoegy Advisers & Ventures 10 The healthcare products regulations in the UK, Canada and Australia use the European Union framework as a foundation. Used as regulatory benchmarks to develop local frameworks UNITED KINGDOM CANADA AUSTRALIA EUROPEAN UNION
MEDICAL DEVICES Copyright © Semoegy Advisers & Ventures 11 Clear definition by regulators Application of appropriate regulatory controls For products that are defined as medical devices
HEALTH PRODUCT DIFFERENCES Copyright © Semoegy Advisers & Ventures 12 MEDICAL DEVICE PHARMACEUTICALS BIOLOGICS Download this document at our Lecture Materials tab. DOWNLOAD Differences between a medical device, pharmaceutical and biological product.
KEY MEDICAL DEVICES ATTRIBUTES Copyright © Semoegy Advisers & Ventures 13 PRIMARY MECHANISM OF ACTION • PHYSICAL • STRUCTURAL • DIAGNOSTIC • PREVENTIVE • INFORMATIVE FORM • EQUIPMENT • TOOL • ENGINEERED OR CONSTRUCTED ARTICLE • SOFTWARE This includes fluid substances
MEDICAL DEVICE DEFINITION Copyright © Semoegy Advisers & Ventures 14 The FORM of a medical device How a medical device FUNCTIONS The INTENDED PURPOSE of the medical device MEDICAL PURPOSE For human use The detailed definition of a medical device can be broken down into three attributes:
FORM OF A MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 15 SOFTWARE IMPLANT IMPLEMENT MATERIAL INSTRUMENT APPLIANC E MACHINE IN VITRO REAGENTAPPARATUS MOBILE MEDICAL DEVICES This includes medical devices that are controlled by or run on mobile platforms.
HOW IS A MEDICAL DEVICE USED Copyright © Semoegy Advisers & Ventures 16 Intended by the Manufacturer For human beings To be used alone Or in combination
INTENDED USE OF A MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 17 Disease Injury Anatomy, or Physiological Process Other Medical Purposes DISEASE • Diagnosis • Prevention • Monitoring • Treatment • Alleviation INJURY • Diagnosis • Monitoring • Treatment • Alleviation • Compensation ANATOMY OR PHYSIOLOGICAL PROCESS • Investigation • Replacement • Modification • Support OTHER MEDICAL PURPOSES • Supporting or sustaining life • Control of conception • Disinfection of medical devices • Providing information by means of in vitro examination. Example text
WHAT A MEDICAL DEVICE DOES NOT DO Copyright © Semoegy Advisers & Ventures 18 DON’T x Pharmacologic x Immunologic x Metabolic DO Does not achieve its primary intended function by these means: May be assisted in its intended function by such means
MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 19 Wound dressing Glucometer Contact Lens Infusion Set Eye Drops X-ray CT scan
MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 20 Wound dressing Injury Treatment & Protection
MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 21 Glucometer Disease Diagnosis & Monitoring
MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 22 Contact Lens Anatomy Modify & Support
MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 23 Infusion Set Physiological Process Support & Sustain
MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 24 Eye Drops Anatomy Support & Sustain
MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 25 X-ray CT scan Disease & Anatomy Diagnosis, Monitoring & Investigation
The examination of these samples outside of the human body, for example in a laboratory or using a measurement instrument. Step 2 IN VITRO DIAGNOSTICS Copyright © Semoegy Advisers & Ventures 26 Retrieval of physiological samples from the human body Step 1 Provides information on an individual’s health or disease condition Step 3 Helps to monitor treatment outcomes Step 4
IN VITRO DIAGNOSTIC MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 27 In Vitro Diagnostics Intended Use • Diagnosis • Aid to diagnosis • Screening • Monitoring • Predisposition • Prognosis • Prediction • Determination
IN VITRO DIAGNOSTIC MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 28 • These devices can be used alone or in combination. • Includes self-testing in vitro diagnostics
IN VITRO DIAGNOSTIC EXAMPLES Copyright © Semoegy Advisers & Ventures 29 Glucometer HIV & Hepatitis Test Blood Grouping Cardiac Marker Genetic Testing
IMPORTANT LEARNING POINTS Copyright © Semoegy Advisers & Ventures 30 Medical devices are highly regulated Highly Regulated Medical devices are intended for a Medical Purpose Medical Purpose Primary mechanism of action: physical, structural or diagnostic Action The definition of a medical device will differ from country to country. Definition The appropriate medical device definition and regulatory controls of that country must be followed. Regulations A medical device does not achieve its primary intended action by pharmacological, immunological or metabolic means. What it does not do In vitro Diagnostics are Medical Devices IVDs
Copyright © Semoegy Advisers & Ventures 31 DOWNLOAD Lecture Materials Tab Slides for this lecture Country-specific medical device definition Healthcare product comparison table
Copyright © Semoegy Advisers & Ventures 32 This lecture is part of the introductory course series for medical devices. For more updates on upcoming lectures, sign up on our website: www.semoegy.com.
REFERENCES Copyright © Semoegy Advisers & Ventures 33 • International Medical Device Regulators Forum (IMDRF) - http://www.imdrf.org/
Copyright © Semoegy Advisers & Ventures 34 Learning
www.semoegy.com Copyright © Semoegy Advisers & Ventures 35

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Medical Device Definition

  • 1. Copyright © Semoegy Advisers & Ventures 1 WELCOME TO SEMOEGY LEARNING
  • 2. Copyright © Semoegy Advisers & Ventures 2 medical technology Education Knowledge Information Resource i
  • 3. Copyright © Semoegy Advisers & Ventures 3
  • 4. SEMOEGY LEARNING For Medical Technology Education, Knowledge & Information Resource MEDICAL DEVICE DEFINITION What is a Medical Device? Copyright © Semoegy Advisers & Ventures
  • 5. COURSE CONTENT • Basic definition of a medical device • Key attributes • Intended purpose • Brief insight into in vitro diagnostic medical device Copyright © Semoegy Advisers & Ventures 5
  • 6. DRUGS / PHARMACEUTICALS Copyright © Semoegy Advisers & Ventures 6 HEALTHCARE PRODUCTS MEDICAL DEVICES BIOLOGICS
  • 7. Healthcare is one of the most regulated industries in the world Copyright © Semoegy Advisers & Ventures 7 HEALTHCARE PRODUCTS Medical devices are highly regulated
  • 8. HEALTH PRODUCTS REGULATION Copyright © Semoegy Advisers & Ventures 8 REVIEW Approval of healthcare products before marketing RISK OF HARM Healthcare products may carry a certain risk of harm to patients EVIDENCE-BASED Associated risks must be reduced or eliminated
  • 9. KEY INFLUENCER REGULATORS Copyright © Semoegy Advisers & Ventures 9 The European Union Directives for Medical Devices and Medicines Health Canada UNITED STATES CANADA The Medicines and Healthcare Products Regulatory Agency of the UK US Food & Drug Administration AUSTRALIA Therapeutic Goods Administration EUROPEAN UNIONUNITED KINGDOM
  • 10. KEY INFLUENCER REGULATORS Copyright © Semoegy Advisers & Ventures 10 The healthcare products regulations in the UK, Canada and Australia use the European Union framework as a foundation. Used as regulatory benchmarks to develop local frameworks UNITED KINGDOM CANADA AUSTRALIA EUROPEAN UNION
  • 11. MEDICAL DEVICES Copyright © Semoegy Advisers & Ventures 11 Clear definition by regulators Application of appropriate regulatory controls For products that are defined as medical devices
  • 12. HEALTH PRODUCT DIFFERENCES Copyright © Semoegy Advisers & Ventures 12 MEDICAL DEVICE PHARMACEUTICALS BIOLOGICS Download this document at our Lecture Materials tab. DOWNLOAD Differences between a medical device, pharmaceutical and biological product.
  • 13. KEY MEDICAL DEVICES ATTRIBUTES Copyright © Semoegy Advisers & Ventures 13 PRIMARY MECHANISM OF ACTION • PHYSICAL • STRUCTURAL • DIAGNOSTIC • PREVENTIVE • INFORMATIVE FORM • EQUIPMENT • TOOL • ENGINEERED OR CONSTRUCTED ARTICLE • SOFTWARE This includes fluid substances
  • 14. MEDICAL DEVICE DEFINITION Copyright © Semoegy Advisers & Ventures 14 The FORM of a medical device How a medical device FUNCTIONS The INTENDED PURPOSE of the medical device MEDICAL PURPOSE For human use The detailed definition of a medical device can be broken down into three attributes:
  • 15. FORM OF A MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 15 SOFTWARE IMPLANT IMPLEMENT MATERIAL INSTRUMENT APPLIANC E MACHINE IN VITRO REAGENTAPPARATUS MOBILE MEDICAL DEVICES This includes medical devices that are controlled by or run on mobile platforms.
  • 16. HOW IS A MEDICAL DEVICE USED Copyright © Semoegy Advisers & Ventures 16 Intended by the Manufacturer For human beings To be used alone Or in combination
  • 17. INTENDED USE OF A MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 17 Disease Injury Anatomy, or Physiological Process Other Medical Purposes DISEASE • Diagnosis • Prevention • Monitoring • Treatment • Alleviation INJURY • Diagnosis • Monitoring • Treatment • Alleviation • Compensation ANATOMY OR PHYSIOLOGICAL PROCESS • Investigation • Replacement • Modification • Support OTHER MEDICAL PURPOSES • Supporting or sustaining life • Control of conception • Disinfection of medical devices • Providing information by means of in vitro examination. Example text
  • 18. WHAT A MEDICAL DEVICE DOES NOT DO Copyright © Semoegy Advisers & Ventures 18 DON’T x Pharmacologic x Immunologic x Metabolic DO Does not achieve its primary intended function by these means: May be assisted in its intended function by such means
  • 19. MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 19 Wound dressing Glucometer Contact Lens Infusion Set Eye Drops X-ray CT scan
  • 20. MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 20 Wound dressing Injury Treatment & Protection
  • 21. MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 21 Glucometer Disease Diagnosis & Monitoring
  • 22. MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 22 Contact Lens Anatomy Modify & Support
  • 23. MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 23 Infusion Set Physiological Process Support & Sustain
  • 24. MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 24 Eye Drops Anatomy Support & Sustain
  • 25. MEDICAL DEVICE EXAMPLES Copyright © Semoegy Advisers & Ventures 25 X-ray CT scan Disease & Anatomy Diagnosis, Monitoring & Investigation
  • 26. The examination of these samples outside of the human body, for example in a laboratory or using a measurement instrument. Step 2 IN VITRO DIAGNOSTICS Copyright © Semoegy Advisers & Ventures 26 Retrieval of physiological samples from the human body Step 1 Provides information on an individual’s health or disease condition Step 3 Helps to monitor treatment outcomes Step 4
  • 27. IN VITRO DIAGNOSTIC MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 27 In Vitro Diagnostics Intended Use • Diagnosis • Aid to diagnosis • Screening • Monitoring • Predisposition • Prognosis • Prediction • Determination
  • 28. IN VITRO DIAGNOSTIC MEDICAL DEVICE Copyright © Semoegy Advisers & Ventures 28 • These devices can be used alone or in combination. • Includes self-testing in vitro diagnostics
  • 29. IN VITRO DIAGNOSTIC EXAMPLES Copyright © Semoegy Advisers & Ventures 29 Glucometer HIV & Hepatitis Test Blood Grouping Cardiac Marker Genetic Testing
  • 30. IMPORTANT LEARNING POINTS Copyright © Semoegy Advisers & Ventures 30 Medical devices are highly regulated Highly Regulated Medical devices are intended for a Medical Purpose Medical Purpose Primary mechanism of action: physical, structural or diagnostic Action The definition of a medical device will differ from country to country. Definition The appropriate medical device definition and regulatory controls of that country must be followed. Regulations A medical device does not achieve its primary intended action by pharmacological, immunological or metabolic means. What it does not do In vitro Diagnostics are Medical Devices IVDs
  • 31. Copyright © Semoegy Advisers & Ventures 31 DOWNLOAD Lecture Materials Tab Slides for this lecture Country-specific medical device definition Healthcare product comparison table
  • 32. Copyright © Semoegy Advisers & Ventures 32 This lecture is part of the introductory course series for medical devices. For more updates on upcoming lectures, sign up on our website: www.semoegy.com.
  • 33. REFERENCES Copyright © Semoegy Advisers & Ventures 33 • International Medical Device Regulators Forum (IMDRF) - http://www.imdrf.org/
  • 34. Copyright © Semoegy Advisers & Ventures 34 Learning
  • 35. www.semoegy.com Copyright © Semoegy Advisers & Ventures 35