EC REP to EU REP – What Does the Latest MDCG Guidance Mean 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.
