Compliance of products with embedded artificial intelligence

International harmonization and interoperability of regulations of products with embedded artificial intelligence (AI) or other digital technologies is a challenge for regulators, but essential in order to achieve regulatory objectives, while avoiding unnecessary technical barriers to trade and multiplication of conformity testing. This task is complicated by the fact that products with embedded AI might change throughout their lifecycle after receiving distant updates, well after they have been released on the market.

This publication establishes the overarching principles which should be taken into consideration for product regulations which largely reflects the principles set out in the United Nations General Assembly “Seizing the opportunities of safe, secure and trustworthy artificial intelligence systems for sustainable development” (A/78/L.49) and the UNESCO Recommendation on the Ethics of AI (SHS/BIO/PI/2021/1) and the WHO Ethics and governance of AI for health. This publication also builds upon the standards that exist today in this field. It is also compatible with the regulations on the topic which have been published to date.

The UNECE WP.6 proposes in the annex of this publication a declaration that government agencies can sign in order to demonstrate their intention to work towards these overarching principles in their product regulation.