Background

The use of standards is voluntary in Europe. However, compliance with applicable 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 Newly Harmonized 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

Note About These Harmonized Standards

These are all “purely-EN” standards; meaning, they are not sourced from an existing international standard (ISO, IEC). Currently, these are the only types of standards being submitted for harmonization.

For more details on why, please read: Why European Harmonized Standards Are Stuck – ISO/IEC v EU Commission Legal Dispute Explained

List of Newly Harmonized MDR Standards

Reference number of the standard	Title of the standard
EN 13795-1:2025	Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
EN 13795-2:2025	Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits
EN 14683:2025	Medical face masks – Requirements and test methods
EN 14180:2025	Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’