New EU standards create certainty for IVD manufacturers
New EU Implementing Decision published
On 8 April 2025, the European Commission adopted Implementing Decision (EU) 2025/679. It amends the existing Implementing Decision (EU) 2021/1195 by recognising new harmonised standards for the sterilisation of medical devices and publishing their references in the Official Journal of the European Union. The adaptation takes current technical and scientific developments into account and supports the implementation of Regulation (EU) 2017/746 concerning In Vitro Diagnostic Medical Devices (IVDR).
What has changed?
The following revised standards have been newly recognised and included in the Annex to Implementing Decision (EU) 2021/1195:
- EN 556–1:2024
Sterilisation of Medical Devices – Requirements for medical devices to be labelled as ‘STERILE’ – Part 1: Requirements for final sterilised medical devices - EN 556–2:2024
Sterilisation of Medical Devices – Requirements for medical devices to be labelled as ‘STERILE’ – Part 2: Requirements for aseptically processed medical devices
The new standards replace the previous versions (EN 556–1:2001 and EN 556–2:2015), the references of which have not yet been published in the Official Journal.
Significance for manufacturers
- For manufacturers of in-vitro diagnostics (IVD), this has the significant advantage that compliance with these standards establishes presumed conformity with the essential safety and performance requirements set out in Annex I of the IVDR – without the need for additional evidence. This not only simplifies the technical documentation, but also significantly accelerates the market access processes.
- At the same time, the updated requirements increase legal certainty in the labeling of sterile IVD products and reduce the risk of regulatory complaints.
Legal background
The revision of the standards is based on a mandate from the Commission to the European CEN and CENELEC standardisation organisations. The aim was to adapt the previous standards to the requirements of the IVDR and to enable their official recognition at the European level.
A recent judgement of the European Court of Justice (C‑588/21 P) also underlines the relevance of the public interest in the transparency of harmonised standards – an aspect that is also emphasised in this decision.
Entry into force
Implementing Decision (EU) 2025/679 shall enter into force upon its publication in the Official Journal of the European Union.
ToDo’s and support from reuschlaw
- IVD manufacturers should quickly check the extent to which their product labeling and technical documentation already comply with the new versions EN 556–1:2024 and EN 556–2:2024. A legal assessment can also clarify whether existing conformity assessments need to be updated.
- reuschlaw provides support in assessing which transitional regulations can be used, which technical documentation needs to be adapted and how communication with notified bodies can be optimized. We work with you to ensure that you meet your documentation obligations precisely and achieve reliable IVDR conformity.
Additional information: A detailed analysis and the full text of the decision are available in the Official Journal of the European Union.
If you have any questions regarding the implementation or the effects on your products, please feel free to contact us.
back