Artificial Intelligence (AI) is redefining the MedTech industry with enabling precision, efficiency, and personalization. Yet as innovation accelerates, regulatory complexity increases.
The European AI Act, the FDA’s Predetermined Change Control Plan (PCCP) framework, and the IMDRF’s Good Machine Learning Practice (GMLP) guidelines are reshaping the way manufacturers develop, design, validate, and maintain AI-based medical devices.
Global Regulatory Landscape
In the EU, the AI-Act and the Code of Practice for General-Purpose AI set clear expectations for transparency, data protection, and systemic risk management. Manufacturers integrating AI must ensure ongoing traceability, bias control, and security across the product lifecycle.
In the U.S., the FDA’s PCCP framework enables adaprive AI/ML models to evolve safety, while maintaining full regulatory oversight throughout the Total Product Lifecycle (TPLC).
Globally, the IMDRF’s GMLP defines harmonized principles for data integrity, performance validation, and post-market monitoring.
Why This Matters for Manufacturers
AI models evolve faster that traditional validation cycles. To maintain compliance, medical devices must remain safe and predictable.
Manufacturers now need structured processes to handle:
- Model updates and revalidation under MDR/IVDR
- Risk and biasmanagement based on GMLP and MDCG 2025-6 principles
- Transparent documentation and traceability aligned with the AI Act
- Clinical benchmarking and post-market evaluation
How WQS Supports You
At WQS, we combine regulatory insight with practical implementation.
Our consultants help you:
- Integrate AI-specific risk management into your MDR / IVDR frameworks.
- Design AI documentation compliant with transparency and copyright requirements.
- Develop lifecycle and change control plans (PCCP) ready for audits.
- Define and validate clinical performance benchmarks for AI-based performance evaluation and MDR Annex XIV.
- Prepare for Notified Body and FDA reviews with confidence.
Learn more about our regulatory consulting services for AI and digital health at us.wqs.de and us.wqs.de.
