Date: 12 June 2023

What is the webinar about?

The EU Artificial Intelligence (AI) Act is a proposed European law on artificial intelligence, and the first law on AI by a major regulator. This webinar will look in detail at the EU AI Act, discussing the framework, approach, timeline, and impact of this new legislation on AI providers and manufacturers.

The Regulatory Services Division of BSI is currently working towards designation as an AI notified body to deliver product certifications. As we continue along this journey, we are committed to supporting organisations towards the applicability of this new law, as well as providing guidance around the new legislative framework. Further resources and additional information will also be provided during the webinar.

Who should attend?

• AI providers who intend to place a product on the EU market.
• Manufacturers who intend to apply for CE marking of their AI-enabled product under any Union Harmonised Legislation (e.g. MDR, IVDR).

What will participants gain?

Attendees will gain a better understanding of the different aspects of the forthcoming EU AI Act, including the timeline, approach to devices classification and co-existence with other regulations.

We will also investigate how we at BSI are building internal capability to support providers and manufacturers in this new legislative framework, and how we are working to ensure we are future-ready to embrace artificial intelligence.

Additional information and resources will also be shared with you.

Mark is the Managing Director of BSI’s Artificial Intelligence Regulatory Services business area. He’s been mobilising and leading this exciting new venture since May 2022. Mark is committed to helping ensure that AI is ethical, trustworthy, and transparent, whist not stifling innovation.

For 18 years Mark has shaped and led the definition and delivery of transformational strategies across a range of industries, focused on how cutting-edge digital innovation can be used to address societies most pressing issues. 

Dr. Aris Tzavaras is the head of AI Notified Body. He joined BSI in 2018 as a Technical Specialist and Scheme Manager within the Active Medical Devices team. As part of his work as Technical Specialist, he has reviewed MDR and MDD active devices including AI software devices.

He has more than 20 years’ experience in Medical Devices including academic lecturing for BSc and MSc Biomedical Engineering programs. He holds a PhD in Health Informatics from City London University on Artificial Intelligence.

Inma is the Regulatory lead of the AI Notified body. She is responsible for the external communications of the Notified body with the relevant competent authorities. Prior to joining BSI in 2022, Inma held several positions in the “Brussels bubble” where she worked on the AI Act regulation and represented the main technology industries before the European institutions.  

A lawyer by training, Inma holds a degree in Law and a specialisation Masters in European Law and has been admitted to the Spanish Bar.

Sarah Mathew is the American Regulatory Lead on behalf of AI Notified Body. She is a technical committee member on the European Committee for Electrotechnical Standardization Strategic Advisory Group for Artificial Intelligence.

Prior to her current role, Sarah was a Technical Specialist and Scheme Manager with BSI’s Active Implantable Medical Device Group, where she performed and led conformity assessments. Her background includes electronic engineering, power systems, and wireless communications.

As Senior Product Manager, Andrea has been shaping product vision since the establishment of BSI’s Artificial Intelligence Regulatory Services business area. By defining how BSI can support companies in development and deployment of AI systems, Andrea is committed to bring his contribute to a virtuous future for AI.

His background is in biomedical engineering and product management experience at global scale reinforced his ability to connect the technical and business worlds managing successful product strategies that addressed critical needs especially in the orthopedic and clinical fields.