Background

The use of standards is voluntary in Europe. However, compliance with the applicable European harmonized standard(s) benefits from 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.

Links to Newly Harmonized Standards

• MDR – the link is available: HERE
• IVDR – the link is available: HERE

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

List of Newly Harmonized Standards

Newly harmonized under the MDR

This brings the number of completed standards to 32 of the 277 requested (12%).

Reference number of the standard	Title of the standard
EN 455-1:2020+A2:2024	Medical gloves for single use – Part 1: Requirements and testing for freedom of holes
EN 455-2:2024	Medical gloves for single use – Part 2: Requirements and testing for physical properties
EN 556-1:2024	Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
EN 556-2:2024	Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices
EN 1865-2:2024	Patient handling equipment used in ambulances – Part 2: Power assisted stretcher
EN 1865-6:2024	Patient handling equipment used in ambulances – Part 6: Powered chairs

Newly harmonized under the IVDR

This brings the number of completed standards to 17 of the 49 requested (35%).

Reference number of the standard	Title of the standard
EN 556-1:2024	Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
EN 556-2:2024	Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices