Life Sciences News in Italy: July 2026

Regulatory

Digital Omnibus on AI enters into force

On 27 July 2026, the Digital Omnibus on Artificial Intelligence (Regulation (EU) 2026/1744) entered into force. First proposed by the European Commission in November 2025 to simplify EU digital legislation and reduce compliance burdens, it amends the AI Act (Regulation (EU) 2024/1689) in response to practical difficulties in implementing it, including delays in designating competent authorities and conformity assessment bodies and the absence of harmonized standards. Among other measures, it revises the timeline for the AI Act’s high-risk obligations, expands the powers of the EU AI Office, streamlines conformity assessment, and clarifies the interplay between the AI Act and the GDPR. Of particular relevance to the medical technology sector, the application date for high-risk AI systems embedded as a safety component in products regulated under Annex I – which includes medical devices and IVDs under the MDR and IVDR – has been postponed to 2 August 2028 (from 2 August 2027). The application date for stand-alone high-risk systems listed in Annex III has separately moved to 2 December 2027, while the transparency obligations still enter into force on 2 August 2026. Companies developing or deploying AI in the life sciences sector should reassess their AI Act compliance timelines accordingly.

AIFA issues guidance on the use of artificial intelligence in promotional materials

On 24 July 2026, the Italian Medicines Agency (AIFA) published guidance on the use of artificial intelligence (AI) in promotional materials for medicinal products. The guidance addresses both generative-AI support for drafting or reviewing content and the inclusion of chatbots and virtual assistants in promotional materials, within the framework of Italian Legislative Decree 219/2006 and the AI Act (Regulation (EU) 2024/1689). AI may not introduce unauthorized content or alter approved information, and companies must verify each output against the SmPC. Moreover, the guidance requires a “human-in-the-loop” model and integration of AI use into the company’s quality-management system, with AIFA able to request algorithm-validation documentation at any time.

MDCG clarifies that only manufacturers may assign UDIs to medical devices

On 22 July 2026, the Medical Device Coordination Group (MDCG) published Position Paper MDCG 2026-5 on the assignment of Unique Device Identifiers (UDIs) as between manufacturers and distributors under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It responds to a practice whereby distributors placing devices on the market under their own trade name – while keeping the manufacturer’s details on the label, as permitted under Article 16(1)(a) MDR/IVDR – had obtained UDI-DI codes in their own name, resulting in the same device being registered in EUDAMED under two different UDI-DIs. The MDCG concludes that only the manufacturer may assign UDIs and register the device in EUDAMED. Accordingly, two UDI-DIs for the same device under different trade names remain possible, but must both be assigned by the manufacturer.

EC publishes a revised GMP Annex 19 on reference and retention samples

On 24 June 2026, the European Commission (EC) issued a revised version of Annex 19 to the EU Guidelines on Good Manufacturing Practice (GMP) on reference and retention samples (Commission Decision C(2026) 4135), which becomes applicable on 24 September 2026 and replaces the 2006 version. The basic model is largely unchanged: the requirements as to sample purpose, storage duration, sample size, storage conditions, written agreements, and closure arrangements remain stable. The substantive changes are concentrated in Section 9, revised to address reference and retention samples for parallel-imported, parallel-distributed and parallel-traded products and repackaging operations, and to clarify the controlled use of photographic or digital retention samples.

 

Antitrust

CJEU clarifies safeguards for access to personal devices during inspections of competition authorities

On 16 July 2026, in a judgment arising from antitrust investigations in the healthcare sector, the Court of Justice of the European Union (CJEU) held that competition authorities may seize during inspections at an undertaking’s business premises emails exchanged between employees without prior judicial authorization, provided that adequate safeguards against abuse are available. The CJEU, however, drew a clear distinction for personal devices: where an inspection extends to devices belonging to natural persons, access to the data stored on such devices must be subject to prior review by a court or an independent administrative body.

EC review finds FSR fit for purpose while proposing targeted amendments

On 14 July 2026, the European Commission (EC) published its first review of the Foreign Subsidies Regulation, concluding that the regime is effectively addressing distortive foreign subsidies and safeguarding a level playing field in the EU internal market. At the same time, the EC acknowledged concerns about the administrative burden and procedural complexity and announced targeted amendments, including higher notification thresholds, streamlined reporting requirements, and additional exemptions. A draft package is expected in autumn 2026, with adoption planned for 2027.

Golden Power report published: overview of the Italian Government’s screening activity in 2025

The Italian Government has published its 2025 Annual Report to Parliament on the exercise of its Golden Power powers. The report confirms a further increase in screening activity compared to the previous year, reflecting the growing number of acts and transactions notified to the Presidency of the Council of Ministers. Covering a broad range of strategic sectors, including healthcare, critical supply chains and key technologies, the Golden Power regime continues to play an increasingly important role in the oversight of investments and transactions involving assets deemed strategic to national security.

 

Employment

New minimum salary increases under the Chemical and Pharmaceutical Industry NCBA

On 1 July 2026, the new increases in the Minimum Economic Treatment provided for by the renewal agreement of the Chemical and Pharmaceutical Industry NCBA signed on 15 April 2025 took effect. The increases apply to employees in the chemical, chemical-pharmaceutical, chemical fibres, abrasives, lubricants and LPG industries. In particular, the July 2026 tranche provides for a monthly increase of EUR 60 for employees classified at level D1, with the relevant amount adjusted proportionately for the other classification levels. The applicable amounts form part of the overall salary increases agreed for the period from 1 July 2025 to 30 June 2028.