SAHPRA has issued guidance on Electronic Instructions for Use (e-IFU) for medical devices and IVDs. This article outlines the key regulatory expectations, risk assessment considerations, eligible device categories, and manufacturer responsibilities.
The MHRA has updated its medical device registration guidance for Great Britain and Northern Ireland. Learn the key regulatory changes, UK Responsible Person requirements, DORS registration process, and practical considerations for manufacturers.
The latest MDCG guidance provides important clarification on the transition from EC REP to EU REP under EN ISO 15223-1. Manufacturers placing medical devices and IVDs on the European market should understand the new symbol requirements, implementation timelines, labeling expectations, and the five-year coexistence period. This article reviews the regulatory update, explains what has changed, and outlines practical steps for maintaining compliance with EU MDR and IVDR requirements.
