NuvoAir’s Air Next Spirometer is Now EU MDR Certified

NuvoAir, a pioneer in value-based specialty care providing proactive and continuous virtual care for people living with heart and lung conditions, has received an updated CE mark certification for its proprietary Air Next spirometer, complying with the new European legislation for medical devices.

What is EU MDR and why is it important?

NuvoAir’s long-standing CE mark signified compliance with the Medical Device Directive (MDD). However, to ensure more stringent regulation of medical devices and better safeguard patients, MDD was replaced by the European Medical Device Regulation (EU MDR). EU MDR is a new set of regulations that governs the manufacturing, distribution, and marketing of medical devices within the European Union. The new regulations are intended to improve the safety and efficacy of medical devices in Europe and to provide a high level of protection for the health of patients. NuvoAir is at the forefront of patient safety and regulatory compliance, receiving the EU MDR certificate 5 in advance of the European regulatory deadline of December 31, 2028.

Key changes introduced by the EU MDR include:

• Stricter Classification System: The regulations introduce a more detailed and comprehensive classification system for medical devices, including factors such as intended use, duration of use, and invasive nature. Increased Scrutiny of High-Risk Devices: High-risk medical devices, such as implantable devices and devices that utilize novel technologies, undergo more rigorous scrutiny by regulatory authorities. This may involve a comprehensive assessment of clinical data and evidence of the device's safety and performance.
• Enhanced Post-Market Surveillance: Companies are required to establish and maintain a post-market surveillance system to monitor performance and safety. This includes reporting and investigating adverse events.
• Unique Device Identification (UDI): A Unique Device Identifier (UDI) is required for each medical device to improve traceability and facilitate rapid and efficient recall of devices, when necessary.
• Increased Requirements for Clinical Evidence: Companies must provide more robust clinical evidence to support the safety and performance of their medical devices including comprehensive data on device performance.
• Economic Operators: The new regulations define specific roles and responsibilities for operators in the medical device supply chain, including manufacturers, authorized representatives, importers, and distributors.

What are the implications for patients and partners?

NuvoAir prioritized a swift transition to the new requirements, which involved an extensive quality and regulatory auditing process. Adapting to the new regulations provides additional validation and security to patients and partners, as the audit assesses the safety and efficacy of the entire product lifecycle. In addition, the new certification expands the intended use for Air Next, qualifying the spirometer for both at-home and in-clinic use. This improves data collection opportunities for clinical management as well as for decentralized and hybrid clinical trials.

“NuvoAir is committed to ensuring that our products adhere to the highest regulatory standards for our patients and our partners,” says Furat Shawki, Head of Quality and Clinical Trials at NuvoAir, “We maintain a patient-first quality policy, striving to continuously expand our medical device approvals and prioritize patient safety.”

In addition to EU MDR, NuvoAir holds the ISO 13485:2016 certification, an international standard for quality management system requirements for organizations involved in the design, development, production, and distribution of medical devices and related services.

Enhance your cardiopulmonary data collection with NuvoAir

Whether you're supporting patients via clinical management or clinical trials in the U.S. or Europe, NuvoAir is your trusted partner for patient-centric, high-quality cardiopulmonary data collection and proactive care. Contact us to learn more about our innovative care model and clinical trial solutions.