**Questions? [[Contact us!]]** When an AI system is classified as a medical device under the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR), it must adhere to the obligations stipulated in the AI Act. There must also be a [[Conformity Assessment]] aligned with the requirements of the [[MDR]] or [[IVDR]]. 1. **Compliance with [[MDR]] or [[IVDR]]**: Ensure that the AI technology used in your medical devices aligns with the requirements outlined in the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) for software. 2. **Familiarise with [[AI Act]]**: Stay informed about the specific requirements of the AI Regulation, especially for high-risk AI systems. Recognise that these requirements may extend beyond those stipulated in the MDR and IVDR. 3. **Conduct comprehensive risk assessments**: Perform thorough risk assessments to guarantee the safe use of AI in your medical devices. Identify potential risks and take measures to prevent adverse effects. 4. **Include AI explanations in documentation**: In your [[Technical Documentation]], provide detailed explanations about the utilisation of AI in your medical devices. Specify the exact nature of the AI technology used and its performance characteristics. 5. **Collaborate with a [[Notified Body (NB)]]**: Collaborate closely with accredited Notified Bodies or those with expertise in AI-based medical devices to guide the conformity assessment process effectively. 6. **Stay informed and adapt**: Continuously monitor the latest developments in the field of AI and medical devices, especially in terms of evolving liability regulations. Be prepared to adapt your products and processes accordingly to ensure compliance and safety.