European Commission Publishes New Harmonised Standards for Sterilisation and IVD Labelling under IVDR
The European Commission has adopted Commission Implementing Decision (EU) 2026/197 of 28 January 2026, amending Implementing Decision (EU) 2021/1195 by adding new references to harmonised standards supporting Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) .
The Decision was published in the Official Journal of the European Union on 30 January 2026 and entered into force on the same day.
What has changed
The amendment formally adds six revised harmonised standards to the Annex of Implementing Decision (EU) 2021/1195. These standards relate to:
Sterilisation of health care products, and
Information supplied by the manufacturer (labelling) for in vitro diagnostic medical devices.
The newly added standards are:
EN ISO 17665:2024 – Sterilization of health care products – Moist heat
EN ISO 18113-1:2024 – IVD labelling – Part 1: Terms, definitions and general requirements
EN ISO 18113-2:2024 – IVD reagents for professional use
EN ISO 18113-3:2024 – IVD instruments for professional use
EN ISO 18113-4:2024 – IVD reagents for self-testing
EN ISO 18113-5:2024 – IVD instruments for self-testing
These standards replace earlier versions developed under Directive 98/79/EC and were revised by CEN and CENELEC to reflect technical and scientific progress and to support the requirements of the IVDR.
Why this matters for manufacturers
From the date of publication in the Official Journal, compliance with these harmonised standards confers a presumption of conformity with the corresponding IVDR requirements covered by those standards.
For manufacturers, this means:
Updated sterilisation validation and routine control requirements may now be relied upon through EN ISO 17665:2024.
Labelling content, structure, terminology and format for IVD devices must align with the revised EN ISO 18113 series, depending on whether the device is intended for professional use or self-testing.
The standards provide a recognised compliance route under the IVDR, which may support technical documentation, conformity assessment activities, and interactions with notified bodies.
Manufacturers using older versions of these standards should assess whether updates to quality management systems, labelling, instructions for use, and technical documentation are necessary in order to align with the newly harmonised references.
Regulatory background
Regulation (EU) 2017/746 fully replaced Directive 98/79/EC as of 26 May 2022. The Commission requested the revision and development of harmonised standards through Implementing Decision C(2021) 2406, with the objective of ensuring continued technical support for IVDR compliance.
Following assessment by the Commission, CEN and CENELEC, the standards were confirmed to satisfy the requirements they are intended to cover, leading to their formal publication in the Official Journal .
Read the full document below.
