To put your AI medical device on the market, it is important to get your strategy right. Since most markets follow either the FDA or the EU approach, we will be looking into both, highlighting similarities and differences.
FDA and European regulatory approaches for AI medical devices
FDA (United States) Approach
The FDA established early frameworks with detailed, practical guidance through Good Machine Learning Practices documents, guidance on AI transparency, and change protocols with clear expectations. Following these guidelines provides a solid foundation for meeting FDA expectations, with options for consultation with the FDA on device-specific requirements.
European Approach
The European regulatory landscape is evolving. Current medical device regulations (MDR/IVDR) lack AI-specific guidance, though Team-NB offers a questionnaire to identify AI-relevant considerations. The upcoming AI Act, effective August 2027 for high-risk AI devices which will include all medical devices that need to undergo Notified Body conformity assessment, will introduce additional requirements addressing environmental impacts like power consumption, ethical considerations, and additional risk assessments. The AI Act affects multiple sectors, but notified bodies for medical devices will likely perform conformity assessments for AI in the healthcare industry, creating a unified evaluation process.
Preparing for regulatory compliance
To minimize the risks of non-compliance and delayed market access, companies should implement foundational quality processes before developing AI components in healthcare and document everything from data selection to model training decisions. Apart from the environmental consequences and the fundamental rights, the same processes would need to be implemented for either the FDA, EU MDR/IVDR and AI ACT market approach. These processes include data collection and data lifecycle considerations. Remember to take a risk-based approach starting with thorough risk management, which is essential, as is staying informed about emerging regulations and guidance. Manufacturers should keep strict separation between research, development, and deployment (post- market monitoring) and consider seeking expert help with the implementation of QMS processes, performing risk management, and setting up templates for technical documentation, which all should be in accordance with the product risk and the size of the organization.
By proactively addressing regulatory requirements early in the development process, companies can avoid costly delays, market access barriers, and potential liability issues associated with AI medical devices. As regulatory frameworks evolve, maintaining a disciplined approach to compliance will be essential for successfully bringing innovative AI into the healthcare market while ensuring patient safety remains the highest priority.
Apart from regular medical device services such as QMS implementations and audits and technical file generation, Qserve offers dedicated support for AI medical devices, including:
- Develop protocols for model retraining and performance monitoring
- Setting up technical file templates for AI elements
- Support Risk Management Activities for AI medical devices/IVD’s
- Implement new / adapt existing QMS to incorporate AI in the healthcare industry
- Implement processes for data management and AI lifecycle oversight
When do you need regulatory help with AI for medical devices?
Integrating artificial intelligence (AI) into healthcare products transforms the industry and introduces complex regulatory challenges. Understanding when to seek specialized regulatory assistance can be crucial for successful market entry and compliance. Here's a guide to help you recognize when external regulatory expertise might be necessary for your AI-enabled healthcare solution.
Consider external regulatory expertise when your organization faces resource constraints that prevent keeping up with rapidly evolving AI regulations. If your team lacks specific knowledge about AI-related quality system requirements or needs to navigate multiple international regulatory frameworks simultaneously, external help becomes valuable.
Another clear indicator is when your documentation structure doesn't adequately address AI-specific elements or when you're unsure how to implement risk management for AI components in your medical device.
Qserve also offers a special service for startups and small manufacturers.
How regulatory experts can help
Regulatory assistance for AI in the healthcare industry generally comes in two forms:
- Strategic consulting. Provides expert advice on regulatory strategy, gap analysis, and implementation planning.
- Hands-on support. Delivers direct assistance with documentation development, quality system modification, and regulatory submissions.
Based on the specific request, available resources at the manufacturer, and the current state of the documentation/QMS a specific support quote can be provided. Interested? Please contact us to indicate your interest.