This newly established harmonized standard under EU MDR addresses biocompatibility evaluation specifically for medical devices with breathing gas pathways, such as ventilators and anesthesia delivery systems. The document provides comprehensive methodology for assessing biological safety of materials and substances in contact with respiratory gases through a risk management framework. Manufacturers should evaluate the biocompatibility potential of device materials and their extractables using appropriate biological testing and chemical analysis methods proportionate to patient exposure duration and conditions. The standard specifies evaluation strategies, test selection criteria, and acceptance criteria for breathing gas pathway components. Requirements apply to all devices intended to deliver or facilitate breathing gas therapy or anesthesia. This standard was published in the EU Official Journal via Decision 2026/193.

This harmonized standard under EU MDR (2017/745) specifies requirements for the biological safety evaluation of medical devices by implementing chemical characterization of materials within a risk management process. The document establishes methods for analyzing and evaluating material-derived substances to ensure safety during device development phases. Manufacturers should conduct systematic chemical characterization of device materials and extract substances according to defined analytical and assessment methodologies. The standard applies to all medical devices regardless of their intended use or risk class, serving as a foundational requirement for biocompatibility evaluation. This amendment was published in the EU Official Journal via Decision 2024/815.

This harmonized standard under EU MDR prescribes systematic risk management processes that manufacturers must implement throughout the medical device lifecycle. The document specifies methodologies for hazard identification, risk analysis, risk evaluation, and implementation of risk control measures with verification and validation. Manufacturers should establish documented risk management files demonstrating that identified hazards have been adequately controlled and that residual risks are acceptable. The standard requires post-market surveillance planning to monitor device performance and identify emerging safety concerns. Risk management must be proportionate to the device's intended use and classification. This systematic approach serves as the foundational framework for ensuring both safety and effectiveness of medical devices. The amendment was published in the EU Official Journal via Decision 2022/757.

This harmonized standard under EU MDR establishes comprehensive requirements for quality management systems in medical device manufacturing and distribution. Manufacturers should implement systematic quality procedures covering the entire device lifecycle, from design and development through production, installation, and post-market surveillance activities. The standard requires organizations to establish documented procedures, maintain traceability, implement change controls, and conduct management review to demonstrate regulatory compliance. Risk-based approaches must be applied to manufacturing processes, supplier management, and complaint handling. The requirements apply to all medical device manufacturers seeking CE marking in the European Union. This amendment incorporates multiple corrigenda and was published in the EU Official Journal via Decision 2022/6.