Module 12 Presentations

29/01/2024

Aspect

Criteria

Technical

- Similar Design - Used under similar condition - Similar specification & properties - Same software algorithm - Similar deployment method - Similar principle of operation

Product Equivalence

MDCG 2020-5

Biological

- Same material or substances - Contact with same human tissues or body fluids - Similar kind of duration of contact - Similar release characteristics of substances - Same clinical condition or purpose - Similar severity and stage of disease - Same site in the body - Similar population (Age, anatomy, physiology) - Similar relevant critical performance

Clinical

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©Copyright Easy Medical Device GmbH

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MEDDEV 2.7/1 Rev 4 Guideline on ClinicalEvaluation

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©Copyright Easy Medical Device GmbH

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