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CE Certification under EU MDR 2017/745 for ICU Ventilators – AVI Healthcare Key Milestone
01, April 2026
CE Certification under EU MDR 2017/745 for ICU Ventilators – AVI Healthcare Key Milestone
AVI Healthcare Pvt Ltd has successfully achieved CE Certification under the European Medical Device Regulation (EU MDR 2017/745) for its ICU Ventilator (VIHA dv10) on 18th March 2026. This certification demonstrates compliance with one of the most stringent regulatory frameworks in the global medical device industry and marks a significant milestone for the organization.
VIHA dv10 ICU Ventilator is Neonatal to Adult Turbine based High end Ventilator which is indigenously developed by us.
Proud to be among the first Indian manufacturers of ICU ventilators to achieve this landmark
EU MDR 2017/745 has significantly increased the level of rigor required for medical device certification, with enhanced expectations around technical documentation, clinical evaluation, risk management, and post-market surveillance.
For critical care devices such as ICU ventilators, meeting these requirements demands a structured and detail-oriented regulatory approach.
The successful CE certification:
- Confirms compliance with EU MDR 2017/745
- Strengthens AVI Healthcare’s global market readiness
- Demonstrates capability in handling complex regulatory pathways
- Reinforces commitment to quality and patient safety
Foundation Built on Experience
Building on prior CE certifications under MDD for devices such as Infant Warmers, Phototherapy Units, and Transport Incubators, this milestone reflects a successful transition to the more stringent EU MDR framework.
This achievement represents not just regulatory compliance, but the establishment of robust systems and processes to support sustained quality and global standards.
AVI Healthcare remains committed to delivering safe, reliable, and high-quality critical care solutions.
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