Summary
The European Parliament’s proposal to move product-regulated AI systems from Section A to Section B of the AI Act may initially sound like a relatively small structural adjustment. In practice, however, the implications could become far more significant for manufacturers working under frameworks such as MDR and IVDR.
In his latest article, Leon Doorn examines how the original AI Act structure developed, why concerns around overlap with sector-specific legislation have existed from the beginning, and how the latest simplification proposals could reshape the relationship between the AI Act and existing medical device regulations.
One of the core themes throughout the article is that the discussion is not simply about reducing requirements. Instead, it shifts the question toward where those requirements ultimately sit. For medical devices and other product-regulated sectors, the proposal may gradually move more AI governance expectations back into sector legislation itself rather than maintaining a fully separate layer under the AI Act.
The article also walks through the broader legislative timeline behind these developments, including the original 2021 Commission proposal, the later trilogue negotiations, the AI Act implementation schedule, and the more recent simplification initiatives introduced by both the European Commission and Parliament.
For organisations working with AI-enabled medical devices, the consequences are not entirely straightforward. While some duplication between MDR/IVDR and the AI Act could potentially be reduced, many practical expectations around risk management, oversight, validation, post-market monitoring, and documentation are unlikely to disappear. In many cases, the operational work may remain largely the same even if the legal structure changes.
The article highlights how these changes may eventually affect conformity assessments, harmonised standards, and future guidance development across the medical device sector. It also underlines the uncertainty that still exists while the proposal moves through ongoing trilogue discussions with the European Council.
Rather than treating the proposal as a purely political or administrative update, the article frames it as part of a much larger discussion around how AI regulation should integrate with already heavily regulated industries such as healthcare and medical technology.
Read the full article here: AI Act Section A to B: Minimal change or far-reaching consequences?
