The European Commission has just published Implementing Decision (EU) 2026/197, marking a step forward for the regulatory framework governing in vitro diagnostic medical devices (IVDs) in the EU.
This new Decision updates Implementing Decision (EU) 2021/1195 by adding references to recently revised harmonized standards that support compliance with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
What’s new?
The Decision introduces six newly revised EN ISO standards, including:
- EN ISO 17665:2024: Sterilization of health care products (moist heat)
- EN ISO 18113-1 to -5:2024: A complete suite of standards on labelling and information provided by manufacturers for IVD reagents and instruments (professional use & self‑testing)
These updated standards reflect the latest scientific and technical progress and help ensure consistency, safety, and clarity across IVD products placed on the EU market.
Why it matters ?
Compliance with these harmonized standards gives manufacturers a presumption of conformity with the essential requirements of the IVDR, significantly facilitating regulatory compliance and product placement within the EU.
The Decision entered into force on the day of its publication in the Official Journal (30 January 2026).
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