The Medical Devices Introductory Course 2020

Regulatory Requirements

Times Risk Mentioned

Legislation

MDD

93/42/EEC (M5)

56

MDR

EU MDR 2017-745

243

IVDR

EU MDR 2017-746

227

The Organisation for Professionals in Regulatory Affairs

Regulatory Requirements

General Requirements – applicable to all devices • Intended use (ergonomic, appropriate to intended user) • Safe and effective design (in terms of the state of the art) • Product lifetime (performance should not deteriorate over intended lifetime) • Packaging (must be adequate to maintain performance characteristics in transit) • Shelf life (product and packaging must not deteriorate over intended shelf life) • Clinical benefit (benefits to patient must outweigh risks)

The Organisation for Professionals in Regulatory Affairs