CE Certified ICU Ventilator Under EU MDR 2017/745 – AVI Healthcare Key Milestone

01, April 2026

CE Certified ICU Ventilator Under EU MDR 2017/745 – A Key Milestone for AVI Healthcare

European CE Certified ICU Ventilator: AVI Healthcare is proud to announce a major milestone in its journey of innovation and regulatory excellence. Our VIHA dv10 ICU Ventilator has achieved CE Certification under the European Medical Device Regulation (EU MDR 2017/745). This milestone makes it one of the first Indian ICU Ventilators  to receive certification under one of the world’s most stringent regulatory frameworks.

As a CE Certified ICU Ventilator, the VIHA dv10 demonstrates compliance with internationally recognised requirements for safety, performance, risk management, and quality. This achievement reflects AVI Healthcare’s continued commitment to developing reliable critical care medical devices that meet global regulatory standards.

A Significant Achievement in Regulatory Excellence

The European Medical Device Regulation (EU MDR 2017/745) is one of the world’s most comprehensive regulatory frameworks for medical devices. Compared to the previous Medical Devices Directive (MDD), the MDR introduces more rigorous requirements for product safety, clinical evaluation, risk management, technical documentation, post-market surveillance, and regulatory compliance.

Achieving CE certification under EU MDR demonstrates that our Critical care Ventilators has successfully undergone an extensive conformity assessment process to meet these enhanced regulatory requirements for the European market. This milestone represents years of dedicated research, engineering, product development, quality assurance, and regulatory preparation.

About the AVI Healthcare Ventilator

The VIHA dv10 is an advanced turbine-driven universal ventilator designed to provide comprehensive respiratory support for adult, paediatric, and neonatal patients. Supporting both invasive and non-invasive ventilation, the ventilator has been developed to meet the demanding requirements of intensive care environments while offering reliability, flexibility, and ease of use for healthcare professionals.

For advanced critical care devices such as ICU ventilators, compliance with the EU MDR requires a structured approach to design, risk management, clinical evaluation, usability engineering, and post-market surveillance, ensuring that the device continues to meet high standards throughout its lifecycle..

What This CE Certification Demonstrates

• Compliance with the European Medical Device Regulation (EU MDR 2017/745).
• Adherence to internationally recognised safety and performance requirements.
• AVI Healthcare’s capability to meet complex international regulatory standards.
• Readiness to support global healthcare markets with internationally compliant medical devices.
• A continued commitment to quality, patient safety, and continuous improvement.

Strengthening India’s Medical Device Ecosystem

India’s medical device industry continues to evolve with an increasing focus on innovation, quality, and global competitiveness. As an Indian medical device manufacturer, AVI Healthcare has consistently invested in indigenous product development, advanced manufacturing practices, and internationally recognised quality systems.

This CE certificate highlights the ability of Indian manufacturers to develop sophisticated critical care technologies that comply with stringent international regulatory requirements. It also reflects the strength of AVI Healthcare’s engineering capabilities, quality management systems, and long-term commitment to regulatory excellence.

Built on a Strong Foundation of Quality

The EU MDR certification builds upon AVI Healthcare’s established quality journey.

Over the years, the company has implemented a robust quality management system and achieved several important certifications, including EN ISO 13485, CE certification for neonatal medical devices such as Infant Warmers, LED Phototherapy Units, and Transport Incubators under the previous Medical Devices Directive (MDD), and ICMED 13485 Plus Product Certification for multiple neonatal care products.

Together, these achievements reflect AVI Healthcare’s continued focus on manufacturing high-quality medical devices that comply with national and international regulatory expectations.

Looking Ahead

Achieving CE Certification under the European Medical Device Regulation (EU MDR 2017/745) marks an important chapter in AVI Healthcare’s growth as a medical device manufacturer. It reinforces our commitment to developing innovative neonatal and critical care medical devices that support healthcare professionals in delivering safe and effective patient care.

As we continue expanding our product portfolio and international presence, AVI Healthcare remains dedicated to advancing medical technology through innovation, responsible manufacturing, and compliance with globally recognised quality and regulatory standards.