Medical Devices Regulation (MDR) 2017/745 - Classification of devices See more https://www.aretezoe.com/medical-devices

1. CLASSIFICATION
OFDEVICES
MEDICAL DEVICES REGULATION (MDR) 2017/745
CHAPTER V, SECTION I, ANNEX VIII
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2. PAGE 2
CLASSIFICATION OF DEVICES
 Chapter V, Section I
 Annex VIII
 Classes I, IIa, IIb, III based on risk
 Disputes referred to Competent
Authority of the Member State
 Member State notifies MDCG and
EC of its decisions
 EC may implement acts to resolve
divergent interpretation

3. DEFINITIONS
DURATION OF USE
 Transient: less than 60 mins
 Short term: 60 mins to 30 days
 Long term: more than 30 days
INVASIVE AND ACTIVE DEVICES
 Body orifice
 Surgically invasive device
 Reusable surgical instrument
 Active therapeutic device
 Active device intended for diagnosis and monitoring
 Central circulatory system
 Injured skin or mucous membrane
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4. IMPLEMENTING RULES
 Classification rules governed by
intended use of the device
 Annex XVI devices (non-medical
purpose) classified separately
 Software falls in the same category as
the device.
 Independently used software is
classified separately
 Most critical use considered
 Highest applicable classification
 Devices that allow direct diagnosis
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5. NON-INVASIVE DEVICES
1. All non-invasive devices are class I
2. Non-invasive devices intended for channeling and storing blood are Class I
 Class IIa if connected with IIa, IIb or III
 Blood bags are Class IIb
3. Non-invasive devices that modify biol/chem composition of human tissues and cells are Class IIb
Non-invasive devices of a substance used in vitro to be returned to body (embryos) are Class III
4. Non-invasive in contact with injured skin or mucous membrane
 Mechanical barrier, absorption, compression are Class I
 Used principally for breached dermis or mucous membrane are Class IIb, heal by secondary intent
 Principally intended to manage wound microenvironment are Class IIa
 All other cases are Class IIa
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6. INVASIVE DEVICES (BODY ORIFICES)
5. All invasive devices with respect to body orifices
not intended for connection with Active device
 Transient use: Class I
 Short-term use: Class IIa
 Long-term use: Class IIb
 Connection with Class IIa, IIb or III: Class IIa
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7. SURGICALLY INVASIVE DEVICES
6. All surgically invasive devices for transient use
are Class IIa unless
 Central circulatory system – Class III
 Reusable instruments – Class I
 Ionizing radiation – Class IIb
 Have biological effect, are absorbed – Class IIb
 Delivery system for medicinal product – Class IIb
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7. All surgically invasive devices for short-term
use are Class IIa unless
 Central circulatory system – Class III
 Direct contact with heart, central circulatory
system, central nervous system – Class III
 Ionizing radiation – Class IIb
 Have biological effect, are absorbed – Class III
 Undergo chemical change in the body (except
teeth) – Class IIb
 Administer medicines - IIb

8. SURGICALLY INVASIVE DEVICES FOR LONG-TERM USE
IMPLANTABLE DEVICES
8. All surgically invasive devices for long-term use and implantable devices are Class IIb unless
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 Teeth– Class IIa
 Direct contact with heart, central circulatory system, central
nervous system – Class III
 Have biological effect, are absorbed – Class III
 Undergo chemical change in the body (except teeth) – Class III
 Administer medicines - III
 Active implantable devices and their accessories – Class III
 Breast implants, surgical meshes – Class III
 Joint replacements – Class III
 Spinal disc replacement implants – Class III

9. ACTIVE THERAPEUTIC DEVICES
9. Administer and exchange energy: Class IIa unless
 Potentially hazardous way – IIb
 Control or monitor performance of active therapeutic devices – IIb
 Ionizing radiation for therapeutic purposes – Class IIb
 Control or monitor performance of active implantable devices – III
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10. ACTIVE DEVICES FOR DIAGNOSIS AND MONITORING
10. Active devices for diagnosis and monitoring are Class IIa unless
 Illuminate patient’s body – Class I
 In vivo distribution of radiopharmaceuticlas – Class IIb
 Direct diagnosis and monitoring of physiological processes – Class IIb
 Emit ionizing radiation for diagnostic or therapeutic purposes – Class IIb
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11. ACTIVE DEVICES: SOFTWARE
Article 46
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11. Software intended to provide
information to support diagnosis or
therapy – Class IIa except
 May cause death or irreversible damage –
Class III
 May cause serious deterioration of
person’s state of health – Class IIb
 Software intended to monitor physiological
processes – Class IIa
 Software intended to monitor vital
physiological processes – Class III
 All other software – Class I

12. ACTIVE DEVICES
12. Intended to remove/administer medicinal products, body
liquids or other substances are Class IIa
unless this is done in a potentially hazardous manner
(Class IIb)
13. All other active devices are Class I
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13. SPECIAL RULES
14. All devices incorporating a medicinal product including human blood or plasma are Class III
15. Contraception.
 Devices for contraception and prevention of transmission of sexually transmitted diseases are Class IIb
 Implantable or long-term invasive – Class III
16. Devices for cleaning, rinsing, disinfecting contact lenses – Class IIb
Disinfecting and sterilizing devices – Class IIa
Solutions and washer disinfectors for invasive devices – IIb
Does not apply devices that clean by means of physical action only
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14. SPECIAL RULES
17. Devices for recording of X-ray images are Class IIa
18. Non-viable tissues or cells of human or animal
origin – Class III
19. Nanomaterials.
High or medium potential for internal exposure -
Class III
Low potential for internal exposure - Class IIb
Negligible potential for internal exposure - Class IIa
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15. SPECIAL RULES
20. Invasive devices with respect to body orifices intended to administer products by inhalation – Class IIa
If their mode of action has essential impact on the efficacy and safety of the medicinal product – Class IIb
21. Devices composed of substances that are applied into a body orifice or on skin to be absorbed or dispersed
 Systemically absorbed – Class III
 Achieve intended purpose in the stomach or lower gastrointestinal tract, systemically absorbed – Class III
 Applied to skin, nasal or oral cavity as far as pharynx – Class IIa
 All other cases – IIb
22. Active therapeutic devices with integrated diagnostic function which determines patient management by
the device (closed loop systems, automated external defibrillators) are Class III
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