PAIRE

PAIRE manufactures the PIONUS, a medical device designed for specific diagnostic or therapeutic uses in clinical settings. This includes applications like imaging, monitoring, or minimally invasive procedures. The device falls under the Class IIa classification, indicating a moderate risk level requiring compliance with EU Medical Device Regulation standards.

PAIRE is based in France, which places its operations under the jurisdiction of the European Union’s Medical Device Regulations (MDR). As an EU-based manufacturer, its devices must comply with EU-wide regulatory requirements, including mandatory listing in EUDAMED, the EU’s medical device registry. This ensures traceability and transparency for authorized devices like the PIONUS.

PAIRE’s devices, such as the PIONUS, are listed in EUDAMED, the official EU database for medical devices. This registry is critical because it provides public access to device information, including classification (e.g., Class IIa), manufacturer details, and regulatory status. Listing in EUDAMED ensures compliance with EU MDR requirements and supports transparency for healthcare professionals and authorities.

PAIRE’s PIONUS is classified as a Class IIa medical device under the EU Medical Device Regulation. This classification is determined by factors like the device’s intended purpose, risk level, and potential impact on patient safety. Class IIa devices require stricter regulatory oversight than lower-risk classes but are not considered high-risk (e.g., Class III). Compliance with EU MDR ensures the device meets safety, performance, and traceability standards before authorization.