Introduction

This edition of our regular column updates the progress of applicable standards to October 2024.

A number of standards across various sectors have been withdrawn, notably by the US Food and Drug Administration (FDA) and the EU, which will impact medical device manufacturers. These newly published standards have been added to the EU harmonised and the US Food and Drug Administration (FDA) consensus lists:

• EN 556-1:2001/AC:2006 (requirements for terminally sterilized medical devices) has been withdrawn and superseded by EN 556-1:2024
• EN ISO 13408-1:2015 (aseptic processing of healthcare products) has been withdrawn and superseded by EN ISO 13408-1:2024
• EN ISO 18113-1 to EN ISO 18113-5 (information supplied by the manufacturer for IVDs) from 2011 has been withdrawn and superseded by a 2024 version, neither of which are on the EU harmonised or the FDA consensus list

Several significant standards are now under review. These include:

• EN ISO 11138-4:2017 (biological indicators for dry heat sterilization processes)
• EN ISO 11140-1:2014 (chemical indicators for sterilization)
• BS EN ISO 10993-7:2008+A1:2022 (ethylene oxide sterilization residuals)
• EN ISO 10993-13:2010 (evaluation of degradation products from polymeric medical devices)
• BS EN ISO 20417:2021 (content labelling)
• EN 12322:1999/A1:2001 (performance criteria for culture media)

New standards have also been introduced to this list:

• ISO 22441:2022 (requirements for the development, validation, and control of low-temperature vaporized hydrogen peroxide sterilization processes), which has been added to the FDA consensus list
• ISO/IEC/IEEE 29119-1:2022 (software testing) has also been added to the FDA consensus list, and accordingly has been added to this list
• In the field of in vitro diagnostics, BS EN ISO 20916:2024 (clinical performance studies using specimens from human subjects) has been introduced and is now an EU harmonised standard
• A new sterility standard concerning moist heat has been added to the FDA consensus list: ISO 17665:2024 (requirements for the development, validation and routine control of a sterilization process for medical devices)

European medical device and IVD harmonised standards have been updated by the Commission Implementing Decision (EU) 2023/1410 of the European Commission for medical devices and Commission Implementing Decision (EU) 2023/1411 on 8 October 2024. The cumulative lists for IVD and medical devices respectively can be found on the Eurlex website.^[1][2]

Please note that, technically, excluding those standards identified in the summary lists published so far, the harmonisation status of the standards identified in the March 2020 list of harmonised standards remains unchanged.

As previously advised, the standing advice to all medical device and IVD companies is to use the most up-to-date version of any applicable standard regardless of its harmonisation status. Anecdotal evidence continues to suggest that this is now expected by all notified bodies in relation to the MDR and IVDR transition in particular. As with previous editions, the table below includes all key harmonised and consensus horizontal standards relating to medical devices and IVDs and represents a comprehensive list of applicable horizontal standards to medical devices and IVDs in as far as is practical. Information on sources for this table can be found in references 1 to 9. A further update will be provided in the next issue of this column.