Commission Implementing Decision (EU) 2026/193 of 28 January 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, non-active surgical implants, sterilization of health care products, biocompatibility evaluation of breathing gas pathways in healthcare applications and small-bore connectors for liquids and gases in healthcare applications

• CELEX: Implementing Decision (EU) 2026/193
• Articles: 3

Article 1

The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In the Annex to Implementing Decision (EU) 2021/1182, the following entries are added:

No

Reference of the standard

‘37.

EN ISO 7197:2024

Neurosurgical implants – Sterile, single-use hydrocephalus shunts (ISO 7197:2024)

38.

EN ISO 10993-4:2017

Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

EN ISO 10993-4:2017/A1:2025

39.

EN ISO 14155:2020

Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)

EN ISO 14155:2020/A11:2024

40.

EN ISO 14630:2024

Non-active surgical implants – General requirements (ISO 14630:2024)

41.

EN ISO 17665:2024

Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)

42.

EN ISO 18562-1:2024

Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)

43.

EN ISO 18562-2:2024

Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)

44.

EN ISO 18562-3:2024

Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)

45.

EN ISO 18562-4:2024

Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024)

46.

EN ISO 21535:2024

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023)

47.

EN ISO 21536:2024

Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023)

48.

EN ISO 80369-2:2024

Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06)’