The use of Artificial Intelligence (AI) in medical devices has gained momentum in recent years. The European Union (EU) has taken a keen interest in regulating AI in the healthcare industry to ensure patient safety and protect public health. In April 2021, the European Commission proposed new regulations on AI, which will have a significant impact on medical devices that utilize AI technology.
The proposed EU AI regulation classifies medical devices that use AI technology as high-risk products. This classification means that medical device manufacturers may need to comply with more stringent regulatory requirements than other AI-enabled products (i.e. those that aren't considered high-risk). The proposed regulations aim to establish a harmonized regulatory framework that ensures safety, transparency, and accountability in the development and deployment of AI across all industries.
Under the proposed regulations, medical device manufacturers must adhere to the requirements of the Medical Device Regulation (MDR) and the In-vitro Diagnostic Regulation (IVDR). These regulations require manufacturers to obtain a conformity assessment of their products, including a risk assessment and clinical evaluation. The new AI regulations will also require manufacturers to conduct post-market surveillance, including monitoring the performance of the AI system, collecting data, and conducting periodic safety updates.
The proposed regulations also require manufacturers to develop and implement technical documentation that describes the AI system's functionality, performance, and intended use. Manufacturers must ensure that their AI systems are designed in a way that ensures transparency, accountability, and robustness. They must also provide users with clear instructions on how to operate the system and ensure that the system is regularly updated to reflect the latest medical knowledge.
In conclusion, the proposed EU AI regulations will have a significant impact on medical products that utilize AI technology. Manufacturers may have to comply with more stringent regulatory requirements than just the MDR to ensure patient safety and public health protection. The new regulations aim to establish a harmonized regulatory framework that ensures safety, transparency, and accountability in the development and deployment of AI. Ultimately, this may help foster trust in AI-enabled medical devices and promote the adoption of innovative technologies that benefit patients and healthcare providers alike, however, there is no clarity how it will resolve any conflicts with the EU MDR regulations.
Learn more about the EU AI Act here - https://artificialintelligenceact.eu/
Disclaimer - This post intended for informational purposes and does not constitute legal information or advice. The materials are provided in consultation with US federal law and may not encompass state or local law.