EU rules

Health Technology Assessment – Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices

The European Commission adopted an implementing regulation establishing the rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint clinical assessments, covering: Cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission …

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EU rules on general-purpose AI models and governance start to apply

On 2 August 2025, the AI Act’s governance has to be in place. This includes the EU-level advisory bodies and the national competent authorities. The Commission has already launched the AI Act’s key advisory bodies. The European AI Board, composed of EU Member States, is fully operational. The Commission has adopted the rules to create the Scientific …

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New EU rules for measuring environmental impact of clothes and shoes

The Commission welcomes the new Product Environmental Footprint Category Rules (PEFCR) for apparel and footwear. These rules introduce a science-based and impartial method to assess the environmental impact of clothing and shoes across their entire lifecycle, from raw material extraction, production and logistics to use and end-of-life. Developed over five years with input from industry, NGOs, national …

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Commission simplifies rules on sustainability and EU investments, delivering over €6 billion in administrative relief

The European Commission has adopted a new package of proposals to simplify EU rules, boost competitiveness, and unlock additional investment capacity. This is a major step forward in creating a more favourable business environment to help EU companies grow, innovate, and create quality jobs. By bringing our competitiveness and climate goals together, we are creating …

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New EU rules on Health Technology Assessment open up a new era for patient access to innovation

The Regulation on Health Technology Assessment (HTA) has become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. This …

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New EU rules to improve Gender Balance in corporate boards enter into application

The Gender Balance on Corporate Boards Directive entered into application at the end of 2024, aiming for a more balanced gender representation on the boards of listed companies across all EU Member States. The Directive sets a target for EU large listed companies of 40% of the underrepresented sex among their non-executive directors and 33% among all directors. …

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Zero Pollution: New EU rules enter into force for cleaner air by 2030

The revised Ambient Air Quality Directive entered into force on Tuesday (10 Dec), aligning 2030 EU air quality standards more closely with World Health Organization recommendations. It is an important step toward better protecting Europeans’ health and moving forward on the path to zero pollution in our environment by 2050. The revised Directive comes with a …

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New EU rules make high-value datasets available to fuel artificial intelligence and data-driven innovation

New EU rules on making more public datasets available for reuse have started applying. These so-called ‘high-value datasets’ contain information on six thematic areas laid out in the Open Data Directive: geospatial, earth observation and environment, meteorological, statistics, companies and mobility. The new rules have the potential to generate important societal and economic benefits by …

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Protecting journalists and promoting media freedom: New rules enter into force

Independent, fact-based journalism helps protect our democracies by exposing injustices, holding leaders to account and allowing citizens to make informed decisions. Journalists, who sometimes work at great personal risk, should be able to work freely and safely. This lies at the heart of EU values and democracies. This week, two pieces of EU legislation enter into force which …

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Heavy-duty vehicles: Council signs off on stricter CO2 emission standards

The Council formally adopted the regulation on CO2 emission standards for heavy-duty vehicles, amending and strengthening the existing EU rules. The updated rules will further reduce CO2 emissions from road transport and will introduce new targets for 2030, 2035 and 2040. More robust standards for CO2 emissions will help increase the share of zero-emission vehicles in the heavy-duty vehicle fleet …

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