The Medical Devices Introductory Course 2020

State of the Art

• Important section and introduced by MEDDEV 2.7.1 rev. 4. • MDR also touches on this by requiring ”a consideration of currently available treatment options” Article 61 (3c) • Typically includes: • Description, natural course and consequences of the medical conditions the device is intended to treat • Whether there are different clinical forms, stages and severities of the conditions • Frequency in the general population, by age group, gender, ethnicity, familiar predispositions, genetic aspects • Description of available therapeutic/ management/ diagnostic options, summary of advantages and disadvantages of the different options, benefit/risk profiles • Types of users – lay person, medical professional • Diverging opinions of professionals as to the use of the different medical options • Unmet medical needs

This doesn’t mean all devices have to be cutting-edge but they do need to show they have a place in the context of current medical knowledge

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Device Equivalence (1)

• Equivalent device: a device that has similar characteristics to the device under evaluation • Similar means no clinically significant difference in performance and safety • Equivalence is determined by an assessment of: • Clinical Characteristics • Technical Characteristics • Biological Characteristics • To be equivalent, all 3 characteristics must be similar to the

extent that there would be no clinically significant differences in safety and clinical performance

MDR Annex XIV Part A (3)

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