Artificial Intelligence: on the way to a European regulation

22 February 2023

With the Commission’s proposal for a regulation, Europe establishes a common position on the rules on artificial intelligence, with the aim of making the EU a world leader and ensuring safe and reliable new technologies


The use of artificial intelligence (AI) technologies is a key opportunity for innovation and growth of the entire European economic and social system, bringing benefits to many fields, including healthcare, the public sector, finance, transport and agriculture. Through improved forecasting, optimised operations and resources, and personalised service delivery, the use of AI provides competitive advantages to European industry.

However, the introduction and use of these new technologies also bring new risks, which must be mitigated through a unique and commonly accepted regulatory framework. In this context, the European Union has undertaken a legislative intervention aimed at ensuring the proper functioning and development of the internal market in the light of the increasing use of artificial intelligence.


The Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act), presented in April 2021, is intended to guarantee that artificial intelligence systems placed on the EU market are safe and ethical, comply with current legislation on fundamental rights, as well as with the values of the Union.

The proposal follows a risk-based approach, establishing a robust and flexible legal framework, which aims to ensure legal certainty and to facilitate investment and innovation in the field of AI.

The key points of the proposal include:

  • definition of the AI system, with clear criteria to distinguish AI from simpler software systems;
  • categorisation of four levels of risk: unacceptable risk, high risk, limited risk and minimal risk;
  • definition of prohibited AI practices;
  • identification of AI systems with a high risk to health and safety or to the fundamental rights of individuals, with identification of specific requirements and obligations for users and suppliers;
  • establishment of the operational framework for notified bodies involved as independent third parties in conformity assessment procedures;
  • implementation of a post-market monitoring system once the IA system is on the market.

The proposed legislation is part of a broader European approach on AI, which aims to promote innovation and strengthen business investment in new technologies, while preserving the safety of citizens and the market.


In the near future, important changes are expected in the regulatory landscape that disciplines the design and use of artificial intelligence systems. New standards and new governance structures will be set up at national and international level, and the Notified Bodies authorised to carry out conformity assessments under the new standards will become operational.

Ente Certificazione Macchine expands its activities to artificial intelligence systems. ECM, always attentive to changes in the market and regulatory environment, promotes technological innovation by ensuring professional and cutting-edge testing and certification services for companies. We are already working to acquire professionalism and expertise in this emerging sector with the aim, in the near future, of obtaing the designation as notified body and performing the required conformity assessments according to the applicable directives and standards that will come into force.

For more information on this topic, please contact us at:

Paolo Bernardoni – Sales Manager ECM | (+39) 345 9938661