EU MDR 2017/745 · BSI Certified
Avicenna.AI’s solutions are certified as medical devices under the EU MDR 2017/745 framework, meeting the highest standards of clinical evidence, post-market surveillance, and regulatory transparency.
Overview
The EU Medical Device Regulation (MDR) 2017/745 replaced the older Medical Device Directive, introducing significantly stricter oversight, clinical evaluation demands, and greater transparency requirements.
For AI-powered healthcare solutions like Avicenna.AI’s, the MDR mandates thorough algorithm testing, detailed technical documentation, and ongoing post-market surveillance to ensure continued safety.
Core European Medical Device Regulation framework
Device classification, high-risk AI diagnostic tools
Independent UK/EU Notified Body certification
Regulatory changes
Stricter clinical evaluation requirements with greater pre-market evidence
Enhanced post-market surveillance and vigilance obligations
Unique Device Identification (UDI) system for traceability
Expanded scope covering software classified as medical devices
Increased requirements for technical documentation and transparency
The MDR represents a fundamental shift in how medical devices – including AI diagnostic software – are regulated in Europe.
Certified portfolio
All Avicenna.AI’s solutions below carry Class IIb medical device certification from BSI under EU MDR 2017/745.
