Inma Perez
Artificial Intelligence Regulatory Lead
BSI
Spain
Inma Pérez is the AI Regulatory lead at the British Standards Institution (BSI). She is responsible for the external communications of the Notified body with the relevant competent authorities and oversights AI projects with external stakeholders. Prior to joining BSI in 2022, Inma has held several positions in the “Brussels bubble” consultancy sector where she worked on the AI Act regulation and represented the main technology industries before the European institutions. Also in Brussels, she worked for the Spanish Permanent Representation to the EU as a European Parliament advisor, gathering a good overview of the Brussels regulatory landscape. 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.
Aiheet
The challenges in AI-enabled medical devices conformity assessments in EU
Developing Health Technology
Artificial Intelligence
7.2.2025 09:45 - 10:15 | Hall 204-205
As the EU Artificial Intelligence Act (AIA) will apply to AI-enabled medical devices in 2027, early planning is crucial. The AIA’s horizontal scope means it will intersect with the Medical Devices Regulation (MDR). The AIA mandates a single conformity assessment for AI-enabled medical devices, which includes additional obligations related to testing, data governance, post-market monitoring, and documentation. This session will explore regulatory overlaps and their impact on the medical devices industry, offering participants a clearer understanding of the conformity assessment process under the AIA.