Background

The use of standards is voluntary in Europe. However, compliance with European harmonized standards provides a ‘presumption of conformity’ with the relevant MDR/IVDR requirements.

While manufacturers are not legally required to use harmonized standards, doing so is often considered the most straightforward, and widely accepted, method for demonstrating compliance, i.e., the ‘path of least resistance’.

In practice, Notified Bodies generally expect manufacturers to apply relevant harmonized standards. Or, if alternative solutions are used, to provide strong evidence that equivalent levels of safety and performance are achieved.

Link to the New Standards

The official link is available: HERE

The following Casus resource has been updated accordingly: Consolidated List of EU MDR/IVDR Harmonized Standards & Common Specifications

List of the New Standards

Reference number of the standard	Title of the standard
EN 13060:2025	Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing
EN 14222:2021+A1:2025	Stainless steel steam boilers
EN IEC 60118-0:2024	Electroacoustics – Hearing aids – Part 0: Measurement of the performance characteristics of hearing aids’