Cut the Red Tape. Unleash AI.

Europe’s AI rules should keep people safe without forcing manufacturers to comply twice for the same product.

Today, companies developing AI-enabled machinery, medical devices, radio equipment and other regulated products can face two overlapping conformity assessment pathways: one under existing sectoral safety legislation and another under the AI Act. DIGITALEUROPE is calling for a simpler approach: merge Sections A and B of Annex I so regulated products follow one coherent compliance pathway. Pasted text

The objective is not to weaken the AI Act. High-risk requirements on transparency, data governance, accuracy, robustness and human oversight would remain. The change would remove duplicated procedures while keeping the same safety obligations. Pasted text

The stakes are significant. The campaign highlights estimated AI Act compliance costs of up to €600,000 per high-risk system in the first year, alongside a wider estimated €31 billion cost to the EU economy over five years. For smaller industrial companies, that burden can directly affect whether an AI product is developed and deployed in Europe at all. Pasted text

A coalition of 48 European associations across 26 countries is backing the call for a more coherent framework that protects safety while giving companies the certainty to keep investing and innovating in Europe. Pasted text