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 rich technical expertise to manufacturers looking to harness the capabilities of medical device AI. A CE-certification for your AI-product from TÜV SÜD will help you fulfil regulations of more markets and access those markets without hassle.

TÜV SÜD experts possess a sound understanding of regulatory safety and performance 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 and our experts are happy to discuss your challenges with you. 

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

We continuously anticipate technological developments in the medical device industry to help manufacturers 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:

• TÜV MARK – We provide the TÜV mark certificate to manufacturers who comply with state-of-the-art requirements on AI in medical devices upon an evaluation. This includes a yearly audit to assess manufacturer compliance with global regulatory standards. 
• Technical Documentation Review – We perform technical documentation review according to certification schemes 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 address the special aspects of AI in medical devices to comply with the General Safety and Performance Requirements and other regulations.
• 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.