KEY TAKEAWAYS
- Avicenna.AI received MDR certification from BSI Medical Devices, under the European Union's MDR 2017/745.
- The certified AI tools are Class IIb medical devices, covering neurovascular and vascular conditions.
- The MDR has a wider scope and more stringent requirements than the previous Medical Device Directive, with emphasis on clinical evaluation and post-market surveillance.
French AI company achieves key EU regulatory compliance for multiple algorithms that identify, detect, and quantify severe conditions from medical images.
La Ciotat, FRANCE – July 3, 2024 – Avicenna.AI, a leading medical imaging AI company, has received Medical Device Regulation (MDR) certificate for its algorithms from certification body BSI Medical Devices. This development means the company’s portfolio is fully compliant with the European Union’s MDR 2017/745, which is now mandatory for medical device companies that want to provide their solutions in Europe.
The MDR was introduced to update the EU’s regulations for medical devices, addressing safety issues and the recent emergence of AI tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, which allows a device to be freely traded in the EU.
MDR VS. MDD
Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management. These measures aim to enhance patient safety and ensure high standards for medical devices, including AI and software-based solutions.
Avicenna.AI’s tools have been certified as Class IIb medical devices, which requires a high level of clinical validation. The certified tools include the company’s suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.
“Obtaining MDR certification is a significant milestone for Avicenna.AI. It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio,”
Stéphane BergerRegulatory Manager at Avicenna.AIThe company’s MDR-certified AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), quantification of stroke severity (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE). All the tools are also CE-marked and FDA-cleared.
“Crucially, despite the differences in SaMD regulatory requirements between authorities in the US and Europe, we are consistently achieving both FDA and CE mark clearance for our AI products,” added Berger.
All of Avicenna.AI’s AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.
