The European Parliament's internal market committee on 25 June 2026 debated the revision of the Medical Devices Regulation (MDR), the 2027 EU budget, the European Product Act, the technological sovereignty package (Chips Act 2.0 and Cloud and AI Development Act), and single market barriers, revealing divergences on regulatory burden, cloud sovereignty, and industrial targets.
On MDR, rapporteur Maria Guzenina (S&D) supported targeted changes but insisted on safety, opposing indefinite certificate validity and proposing five-year reassessment and unannounced audits. Henrik Dahl (EPP) welcomed the proposal but argued it added burdens on in-house devices and reprocessing, vowing a more industry-friendly approach. Cynthia Ní Mhurchú (Renew) said the EU is losing its medical device industry due to complex regulation, seeing simplification counterbalanced by the rapporteur. Andreas Schwab (EPP) argued post-PIP regulation went too far, calling for one AI control instead of two. Commission official Flora Giorgio countered that a patient version of safety reports would cost €40,000–72,000 per manufacturer.
On extended producer responsibility, Pál Szekeres (substituting rapporteur) proposed suspending obligations only for micro and small enterprises until July 2029 or the Circular Economy Act. The Commission argued this fragments the single market and incentivizes staying under thresholds.
On the Cloud and AI Development Act, Christel Schaldemose (S&D) questioned whether the Commission should act or leave it to the market. Alexandra Geese (Greens-EFA) doubted sovereignty, noting only level 4 assurance is truly European, and argued fast permitting prioritizes hyperscalers over European firms. Leila Chaibi (The Left) said Europe needs its own cloud, citing a French Senate hearing where a Microsoft-Capgemini venture admitted US injunctions could not be resisted. Kim van Sparrentak (Greens-EFA) questioned tripling cloud capacity and the US model. Elisabeth Dieringer (PfE) noted €120 billion for semiconductors and €20 million for gigafactories are not guaranteed, and the Court of Auditors deemed the 20% market share target unrealistic, now at 10.5%. Anna Cavazzini (Chair, Greens-EFA) questioned why digital aspects were not in the IAEA. Kilian Gross (DG CNECT) responded that the EU does not require buying European due to market gaps, and a domestic-or-equivalent approach is more pragmatic.
On Chips Act 2.0, Gross acknowledged missing the 20% target but noted absolute capacity growth with €52 billion investments. Consensus emerged on MDR burdens, certification bottlenecks, and market surveillance gaps due to online trade, with agreement that customs reform will improve data access. The next meeting is on 13–14 July.