Module 15 2022

19/05/2022

Technical equivalence

MDR Annex XIV Part A section 3 • Technical: • the device is of similar design; • is used under similar conditions of use;

• has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; • uses similar deployment methods, where relevant; • has similar principles of operation and critical performance requirements; NOTE: ‘such as’ – this is list not exhaustive (MDCG 2020-5) – you must identify all relevant technical characteristics for the device under evaluation

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

13

Technical equivalence

MDR vs MDD (MEDDEV 2.7/1 rev 4)

Source: MDCG 2020-5

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

14

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