A provisional political agreement reached on 7 May 2026 would move Annex III high-risk AI obligations from 2 August 2026 to 2 December 2027, while Annex I product-related obligations for areas such as medical devices and in vitro diagnostics would shift from 2 August 2027 to 2 August 2028. The agreement still requires formal adoption by the European Parliament and the Council, with institutions aiming to complete that before 2 August 2026.
The delay changes the implementation timetable, not the substance of the EU AI Act. Pharma companies still need operating systems to inventory AI, classify risk, manage documentation, validate GxP-relevant uses, oversee vendors, monitor systems after deployment and coordinate legal, quality, regulatory, IT, security, procurement and business teams.
The scope is not limited to companies headquartered in Europe. Under Article 2(1)(c), providers and deployers outside the EU may be covered when outputs from their AI systems are used in the EU. Article 22 also requires third-country providers of high-risk AI systems to designate an authorised representative established in the EU before making those systems available on the EU market.
