Module 15 Presentations

10/04/2024

Technical equivalence

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

13

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’ – the list is 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 7

14