European Commission Publishes Updated Harmonised Standards Under MDR
On 28 January 2026, the European Commission adopted Commission Implementing Decision (EU) 2026/193, amending Implementing Decision (EU) 2021/1182 as regards harmonised standards in support of Regulation (EU) 2017/745 on medical devices (MDR).
The Decision was published in the Official Journal of the European Union (OJ L series) on 30 January 2026 and entered into force on the same day.
Purpose of the Decision
In accordance with Article 8(1) of Regulation (EU) 2017/745, devices that are in conformity with relevant harmonised standards, the references of which are published in the Official Journal of the European Union, are presumed to be in conformity with the requirements of the Regulation covered by those standards.
The Decision amends the Annex to Implementing Decision (EU) 2021/1182 by adding references to revised harmonised standards and amendments developed by CEN and CENELEC in response to the Commission’s standardisation request C(2021) 2406.
Standards Added to the Annex
The following entries have been added to the Annex of Implementing Decision (EU) 2021/1182:
EN ISO 7197:2024 – Neurosurgical implants – Sterile, single-use hydrocephalus shunts
EN ISO 10993-4:2017 and EN ISO 10993-4:2017/A1:2025 – Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
EN ISO 14155:2020 and EN ISO 14155:2020/A11:2024 – Clinical investigation of medical devices for human subjects – Good clinical practice
EN ISO 14630:2024 – Non-active surgical implants – General requirements
EN ISO 17665:2024 – Sterilization of health care products – Moist heat – Requirements for development, validation and routine control
EN ISO 18562-1:2024 – Biocompatibility evaluation of breathing gas pathways – Part 1
EN ISO 18562-2:2024 – Part 2: Tests for emissions of particulate matter
EN ISO 18562-3:2024 – Part 3: Tests for emissions of volatile organic substances
EN ISO 18562-4:2024 – Part 4: Tests for leachables in condensate
EN ISO 21535:2024 – Joint replacement implants – Hip
EN ISO 21536:2024 – Joint replacement implants – Knee
EN ISO 80369-2:2024 – Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications
Entry into Force
The Decision states that compliance with a harmonised standard confers presumption of conformity with the corresponding requirements of Union harmonisation legislation from the date of publication of its reference in the Official Journal of the European Union.
Implementing Decision (EU) 2026/193 entered into force on the day of its publication.
