Medical Device Definition
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The document provides an overview of medical technology education, focusing on the definition and regulation of medical devices. It details the attributes and intended purposes of medical devices, as well as the regulatory frameworks across various countries. Additionally, it highlights the distinction between medical devices, pharmaceuticals, and biologics, and includes examples of medical devices and their functions.
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