CLASSICA D8.1 Regulatory Landscape

Sara Gerke; Mindy Duffourc

doi:10.5281/zenodo.17638961

CLASSICA D8.1 Regulatory Landscape

Sara Gerke (Editor)
, Mindy Duffourc (Editor)

Research output: Book/Report › Book editing › Academic

Abstract

CLASSICA D8.1 ‘Regulatory Landscape’ provides an overview of the EU legislative framework applicable to the development and evaluation of medical AI devices and describes how the regulatory requirements have been implemented in the CLASSICA project, which aims to develop and clinically validate an AI-based support system for surgery.

Original language	English
Place of Publication	Brussels
Publisher	CLASSICA project
Commissioning body	European Union
Number of pages	47
DOIs	https://doi.org/10.5281/zenodo.17638961
Publication status	Published - 19 Oct 2025

Keywords

Horizon Europe
GDPR
AI Act (AIA)
Medical Device Regulation (MDR)
Medical AI

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10.5281/zenodo.17638961Licence: CC BY

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KW - AI Act (AIA)

KW - Medical Device Regulation (MDR)

KW - Medical AI

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CLASSICA D8.1 Regulatory Landscape

Abstract

Keywords

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