Artificial Intelligence in medical devices

Artificial Intelligence (AI) is bringing transformative value to medical devices. Artificial intelligence in medical devices fulfils human capabilities in a variety of roles such as:  

• Optimisation of medical therapy  
• Diagnostic support application   
• Prediction of disease  
• Data classification and analysis for disease outbreak  

Regulators have responded to this shift by requiring AI-driven medical devices to comply with requirements and provide evidence for repeatability and reliability. Regulations that cover AI in medical devices include the Medical Device Regulation (MDR), In Vitro Medical Device Regulation (IVDR) and U.S. Food and Drug Administration (FDA) regulations. In the future this will also include the EU AI Act, which will be fully in power by 2027. Areas regulated include training and verification data, algorithm creation and risk management.  

This necessitates a trusted third-party certification service provider such as TÜV SÜD. We provide conformity assessments for medical device AI thanks to our medical device and healthcare experts who possess leading competence in assessing AI in medical devices and applications. We provide technical expertise   assessing the medical device containing AI against regulatory requirements. A CE-certification for your AI-product from TÜV SÜD can help you fulfil regulations of more markets and access those markets without hassle. 

TÜV SÜD experts possess a sound understanding of regulatory safety standards. We assess if manufacturers meet all relevant requirements of AI in medical devices and provide CE-certification for these products.   

If you have further questions regarding this process or your regulatory strategy related to your AI medical device product, get in touch through this form. Our experts are happy to explain the certification process. 

As a trusted partner of choice for safety, security and sustainability evaluations, we build acceptance of new technologies and their competencies. This includes evolutions in technologies of software compliance and cyber security.  

We continuously anticipate technological developments in the medical device industry and understand that manufacturers face a challenge to adapt to ever-changing requirements. We updated our services regularly in response to changes. The next step for us is the implementation of conformity assessment for products falling under the EU AI act. 

TÜV SÜD provides the following services to address the regulatory compliance of artificial intelligence in medical devices:  

• Technical Documentation Review – We perform technical documentation review as part of conformity assessments prescribed by MDR and IVDR on the use of AI in medical devices.  
• CE certification – We certify AI medical products according to the medical device regulation (MDR).  
• Structured dialogue – We provide technical meetings to explain the aspects of conformity assessment process for AI in medical devices.  
• Trainings – We provide training on the current status of regulatory requirements and standards of AI in medical devices with reference to the requirements of medical AI.