WG-15 – Medical Equipment

WG-15 reports to the Medical Gases Council and focuses on the regulation, quality and safety of medical devices used with medical gases or gases that are qualified as medical devices.

WG-15 Mission: Our mission is to ensure the safety, quality, regulation, and standardization of medical devices used in conjunction with medical gases or gases qualified as medical devices. By bringing together industry experts, we strive to safeguard the well-being of patients, end-users, and professionals while ensuring a level playing field for the industry.

WG-15 Activities:
• Serve as focal point within EIGA for all matters related to the registration, production, storage, handling, use, distribution, and disposal of medical devices.
• Establish industry best practices and develop relevant publications, advocating for their implementation.
• Offer guidance to stakeholders and contribute to the development of legislation and standards.
• Collaborate closely with other EIGA working groups, particularly WG7 focusing on medical and breathing gases and WG10 focusing on homecare, to align work programs and provide expert advice.
• Provide recommendations and support to EIGA and its members in responding to reported incidents and adverse events involving medical devices.
• Liaise with key entities such as the Medical Device Coordination Group (MDCG), European Committee for Standardization (CEN), International Organization for Standardization (ISO), World Health Organization (WHO) and other industry organizations dedicated to enhancing safety and standardisation in the medical devices sector.