The European Commission has introduced two new initiatives aimed at simplifying regulations in the food and feed safety sector and the medical devices industry. The proposals were presented by Commissioners Valdis Dombrovskis and Olivér Várhelyi at a press conference.
Commissioner Dombrovskis outlined that these initiatives are part of a broader agenda to reduce administrative burdens across key sectors. “Regarding the Food and Feed Safety Omnibus, the administrative cost savings are estimated at €939 million per year. For medical devices, we estimate the administrative cost savings amount to €2.4 billion per year,” he said. He added that combined with other ongoing simplification efforts, total annual savings could reach approximately €14.3 billion, moving towards an overall target of reducing administrative costs by 25%—and 35% for small and medium-sized enterprises (SMEs)—by the end of the current Commission’s mandate.
On food and feed safety, Dombrovskis emphasized measures such as making pesticide approval processes more agile, facilitating authorization of low-risk pesticides across multiple member states, encouraging sustainable alternatives through simplified procedures, enabling digital labeling options for businesses, and accelerating market access for bio-pesticides. He stated these changes would benefit farmers by offering more choices for food production inputs and help national authorities focus on higher-risk areas by freeing up resources.
For medical devices, Dombrovskis highlighted steps to streamline reporting obligations, clarify certification rules—including greater use of real-world evidence—and expand digitalization within regulatory processes such as electronic instructions and digital conformity assessments. “Today’s proposals will speed up access to innovative medical devices and boost the competitiveness of a sector that is vital to Europe’s economy,” he said.
Commissioner Várhelyi focused on healthcare challenges facing Europe due to an aging population and rising chronic diseases. He pointed out that while Europe has a strong scientific base in biotechnology, its share in global clinical trials has declined from 22% to around 12% over ten years, with only 7% of venture capital in health biotech coming from Europe.
Várhelyi explained that the proposed Biotech Act aims to make Europe more competitive globally by creating favorable industrial, financial, and regulatory conditions. “It means authorizing clinical trials will not take longer than 47 days… We will also let AI speed up clinical trials,” he noted. The Act introduces incentives like extra patent protection years for key innovations through Supplementary Protection Certificates and seeks to mobilize public-private capital—starting with €10 billion alongside the EIB Group—to support biotech companies’ growth.
He also addressed reforms intended to simplify medical device regulations further: “We propose a major simplification so safe and effective devices can reach patients faster… There will be one single regulatory pathway for AI medical devices.” New rules set predictable timelines (105 days) for product certification in line with international standards.
Additionally, Várhelyi announced plans under the Safe Hearts Plan—a response to cardiovascular disease—that emphasize prevention through regular health checks, harmonized national programs among Member States, public awareness campaigns such as “Know Your Numbers,” mobile screening pilots, modernization of tobacco control rules in 2026, attention on ultra-processed foods in coming years, and investment in AI-driven diagnostic tools (€20 million earmarked for 2026).
Both commissioners stressed that legislative progress is necessary before benefits are realized by citizens or businesses. As Dombrovskis concluded: “It is crucial that we continue to make progress in the legislative process and that co-legislators at least maintain the overall level of ambition of the original proposals.”