On 17 June 2026, the Italian Senate transmitted a formal opinion to the Council of the European Union challenging the compliance of a proposed regulation with the Principles of Subsidiarity and Proportionality. The proposal, referenced as 16919/25 - 2025/0404(COD), aims to simplify and reduce the burden of rules on medical devices and in vitro diagnostic medical devices by amending Regulations (EU) 2017/745 and (EU) 2017/746, as well as related amendments to Regulations (EU) 2022/123 and (EU) 2024/1689. The Italian Senate's opinion, attached to a cover note published by the Council on 24 June 2026, specifically questions whether the EU-level action is necessary and proportionate, potentially signaling a pushback from national parliaments concerned about overreach. The proposal, introduced by the European Commission, seeks to streamline regulatory requirements to enhance competitiveness and innovation in the medical devices sector, which has faced criticism for high compliance costs and delays in market access. However, the Italian Senate's intervention raises the possibility of a 'yellow card' procedure under the EU's subsidiarity control mechanism if other national parliaments join the objection. The opinion focuses on whether the EU's intervention is justified given that medical device regulation has traditionally been harmonized at EU level, but the Italian Senate appears to argue that the proposed simplifications may go beyond what is necessary. The move could delay the legislative process, as the Commission would be required to review the proposal if a sufficient number of national parliaments object. The proposal is currently under consideration by the European Parliament and the Council, with the Italian Senate's opinion adding a layer of scrutiny that may influence the final text. The outcome will affect manufacturers, notified bodies, healthcare providers, and patients, as the regulation aims to reduce administrative burdens while maintaining safety standards.
The Italian Senate's concerns highlight a tension between EU-level harmonization and national sovereignty, with potential implications for the speed of regulatory approvals and market access for medical devices across the EU.