COCIR analyses application of medical device legislation to Artificial Intelligence
“The European Commission has shown its ambition in the area of artificial intelligence (AI) in its recent White Paper on Artificial Intelligence – a European approach to excellence and trust. This White Paper is at the same time a precursor of possible legislation of AI in products and services in the European Union. However, COCIR sees no need for novel regulatory frameworks for AI-based devices in Healthcare, because the requirements of EU MDR and EU IVDR in combination with GDPR are adequate to ensure that same excellence and trust.” (COCIR paper).