Introduction

This edition of our regular column updates the progress of applicable standards to May 2025.

Several significant standards relevant to medical devices and in vitro diagnostic (IVD) products have been introduced, withdrawn or amended. These changes reflect ongoing efforts by standardisation bodies and regulatory authorities to align technical requirements with evolving safety and performance expectations. Many of these revisions affect compliance under the EU Medical Device Regulation (MDR), the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) and the US Food and Drug Administration’s (FDA) requirements.

Newly published or revised standards added to this list include:

• EN 556-1:2024 – Requirements for medical devices to be designated ‘STERILE.’ Requirements for terminally sterilized medical devices. This new standard supersedes the withdrawn EN 556-1:2001/AC:2006. It applies to both medical devices and IVDs and has been added to the EU harmonised list
• EN 556-2:2024 – Requirements for medical devices to be designated ’STERILE’ – Part 2: Requirements for aseptically processed medical devices. This standard replaces EN 556-2:2015, which has now been withdrawn. It also applies to IVDs and is included on the EU harmonised list
• EN ISO 14630:2024 – Non-active surgical implants – General requirements. This new edition supersedes EN ISO 14630:2012, which has now been withdrawn

Withdrawn standards include:

• EN 556-2:2015 – Withdrawn and replaced by the 2024 version as noted above
• EN ISO 14630:2012 – Now officially withdrawn, having been superseded by the 2024 version
• EN ISO 10993-10:2013 – Biological evaluation of medical devices – Tests for irritation and skin sensitization. This standard has been removed from the FDA consensus list

These changes are supported by contributions from relevant technical committees, including CH/198 for sterilisation standards and ISO/TC 150 for surgical implant standards.

European medical device and IVD harmonised standards were last updated under Commission Implementing Decisions (EU) 2023/1410 and 2023/1411, published on 8 April 2025. The cumulative lists for harmonised standards remain available via the Eur-Lex website.

Please note: unless otherwise stated in the official summary lists, the harmonisation status of standards included in the March 2020 list remains unchanged.

As consistently advised, all medical device and IVD manufacturers are encouraged to adopt the most up-to-date version of any applicable standard, irrespective of its current harmonisation status. There remains strong anecdotal evidence that this approach is now universally expected by notified bodies, particularly during the MDR and IVDR transition period.

As with previous editions, the table below includes all key harmonised and consensus horizontal standards relating to medical devices and IVDs and aims to provide a comprehensive list of applicable standards to the extent practical. References 1 to 9 provide further source information. A subsequent update will be provided in the next edition of this column.