Swissmedic has announced the official authorisation of PulmoProDiff®, marking a critical milestone in respiratory diagnostic technology. Clinical, regulatory, and quality teams alike should note this development, as the device now complies with the stringent Swissmedic standards for safety and performance.
What changed?
On November 5, 2025, Swissmedic authorised PulmoProDiff® as part of its approval process for medical devices entering the Swiss market. This marks the first authorisation for the product, which has been designed specifically for advanced respiratory diagnostics. With this clearance, the device complies with stringent safety, quality, and performance criteria.
The authorisation opens pathways to new diagnostic possibilities in pulmonary health. Such approvals ensure compliance with Swiss medical device standards, which are deeply aligned with international best practices.
Safety and performance
Regulatory compliance
According to Swissmedic standards, medical devices must demonstrate a high level of both safety and effectiveness. PulmoProDiff® underwent rigorous evaluations to ensure compliance with these specifications. These assessments include performance validation and the demonstration of risk management protocols specifically targeting patient safety during use.
Clinical applications
PulmoProDiff® is engineered to assist healthcare providers in diagnosing complex pulmonary conditions with enhanced accuracy. Such advancements may reduce diagnostic timelines, improve patient outcomes, and offer clinicians advanced tools for intervention planning.
Implications for quality teams
Quality teams should prepare for integration by understanding PulmoProDiff’s authorised usage, documentation, and required compliance tracking associated with Swissmedic-cleared devices. This authorisation lays the framework for continued alignment with Swiss regulatory standards.
FAQ
Q1: What is PulmoProDiff® designed to do?
PulmoProDiff® is designed for advanced respiratory diagnostics, targeting accuracy in identifying pulmonary conditions.
Q2: Who regulates this device in Switzerland?
PulmoProDiff® has been regulated under Swissmedic’s guidelines.
Q3: How does this approval affect healthcare professionals?
Healthcare professionals can now access a Swissmedic-authorised tool for improved diagnostic capability in respiratory health.
Conclusion
In summary, the regulatory approval of PulmoProDiff® provides healthcare systems and professionals access to a new standard of respiratory diagnostics. Regulatory teams, particularly in Switzerland, should take note of this milestone to ensure alignment with current standards and practices.
Disclaimer
This publication is designed for informational purposes and does not constitute legal advice. Always refer to Swissmedic directives for clarity and compliance.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/public-summary-swiss-par/public-summary-swiss-par-pulmoprodiff.html