The compliance route for AI medical devices entering the EU market rests on the coordinated regulation of the MDR/IVDR and the EU Artificial Intelligence Act (AIA). This means a device must meet both the safety and performance requirements for medical devices and the trustworthiness requirements specific to artificial intelligence.
The EU Artificial Intelligence Act (AIA) entered into force in August 2024. For medical devices classified as high-risk AI systems, its compliance requirements become mandatory from 2 August 2027. This means the period from now until 2027 is the preparation period for “dual compliance” with the MDR/IVDR and the AIA.
The core provisions for high-risk AI medical devices are:
2. Harmonised standards in the AIA compliance route
Key action: to avoid duplicated work, companies should use the right granted by Article 8(2) of the AIA to integrate the new AIA requirements (such as data governance, algorithm transparency, human oversight and management systems) into their existing MDR/IVDR technical documentation and processes.
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International standards applicable to the conformity assessment of AI medical devices:
EN 62304: Medical device software – Software life cycle processes
EN 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices
IEC 82304-1: Health software and IT security
IEC TR 60601-4-5: Core technical guidance on cybersecurity for medical electrical equipment
EN ISO 14155: Clinical investigation of medical devices for human subjects – Good clinical practice
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Key standards to reference when building your management systems:
ISO 13485: Medical devices – Quality management systems
EN ISO/IEC 27000 series: Information security management systems
ISO 14971: Medical devices – Application of risk management
ISO/IEC 42001: Artificial intelligence management systems
IEC 81001-5-1: Health software and health IT systems safety and security
3. Focus areas and challenges in conformity assessment: compared with traditional medical devices, AI medical devices face special challenges in conformity assessment – clinical reports, data management and model development are all difficult areas:
Challenges in assessing new risks arising from the characteristics of AI technology:
Challenges in the transparency of algorithm evaluation:
4. A brief roadmap for placing AI medical devices on the EU market:
This is a series of educational articles introducing FDA, NMPA, GMP, CE MDR/IVDR and MDSAP regulations and standards
Everbiz is happy to share medical device expertise with industry clients and hopes our extensive hands-on experience in quality systems and product registration will be of help to you.
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Shanghai: Room 705, Building 6, Lane 111, Luxiang Road, Baoshan District, Shanghai | Germany: Landsberger Str. 155, 80687 München, Germany
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Hong Kong: Room A1, 11/F Winner Building, 36 Man Yue Street, Hung Hom, Kowloon, Hong Kong
Thailand: No. 850 Soi Lat Krabang 30/5, Lat Krabang Subdistrict, Bangkok 10520
