Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Medical Device Software

Source: MDCG Infographic: Is your software a Medical Device?

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Medical Device and IVD Class

In-Vitro Diagnostic Medical Devices

Medical Devices

Examples: Blood screening High risk disease

Examples: Automated defibrillator Pacemaker Prosthetic heart valves

Class D

Class III

Examples: Blood tissue compatibility Infectious disease Cancer testing Self-testing

Examples: Signals monitoring machine Blood bag Implantable plate

Class IIb

Class C

Examples: Imaging machine Syringes for pump infusion

Examples: Self testing for non-critical conditions

Risk

Class IIa

Class B

Examples: Specific IVD reagents Specimen receptacles Instruments

Examples: Wheelchair Bandage

Class I

Class A

Im

Ir

Is

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