Monthly Summary of Regulatory Updates

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

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

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020) - EN ISO 14155:2020/A11:2024

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

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)

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

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

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

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

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

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

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2022)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

Notice concerning the functionality and compliance with functional specifications of certain electronic systems forming part of the European database on medical devices referred to in Article 34, paragraph 1, of Regulation (EU) 2017/745 of the European Parliament and of the Council

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

Sterilizers for medical use - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Medical face masks - Requirements and test methods