The European Commission published, on 21 April 2021, a Study to Support an Impact Assessment of Regulatory Requirements for Artificial Intelligence in Europe, authored by the Centre for European Policy Studies ('CEPS'), ICF International Inc., and Wavestone. In particular, the study, released on the same day as the Commission's proposal for an AI regulation, provides a comprehensive overview of existing evidence and prospective assessments of the risks and harms generated by AI for fundamental rights as well as for safety and security, while also examining emerging national experiences in developing strategies and regulatory frameworks in this domain, with specific emphasis on risk governance. Furthermore, the study provides a detailed analysis of the results of the public consultation on the European Commission White Paper on Artificial Intelligence.

The final section of the study is dedicated to an assessment of the compliance costs generated by the proposed AI regulation, including both administrative burdens and substantive compliance costs. Among the study's findings and projections, it estimates that total annual compliance costs for an average AI product, taking into account training data, record-keeping, provision of information, human oversight, accuracy and robustness, will amount on average to approximately €30,000, or roughly 17% of total AI investment cost.

You can read the study here.