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NEWS
The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has published results from its second survey on the availability of medical devices and in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Device Regulation (IVDR)). The survey covers both devices already placed on the market and those intended for future placement, considering legacy and newly developed products. It spans all risk classes, with particular focus on devices requiring the involvement of a notified body.
NEWS
The European Commission has published a revised version of Annex 19 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use, replacing the 2006 version. The revision follows recommendations from the GMP/GDP Inspectors Working Group and PIC/S Committee and focuses on reference and retention samples for parallel imported, parallel distributed and parallel traded products. The updated guidance introduces requirements on retention samples for re-packaged products, including the use of photographic/digital samples where physical samples cannot reasonably be retained and clarifies storage, traceability, written agreement and access requirements. The revised annex will apply as of 24 September 2026.
NEWS
The European Commission has published a Strategic Roadmap for Digitalisation and Artificial Intelligence (AI) in the energy sector as part of the EU Technological Sovereignty Package. The roadmap addresses the growing energy demand from digital infrastructure and sets out how AI and digital solutions can support a clean, competitive and secure EU energy system. This includes helping consumers shift electricity consumption to periods when electricity is cheaper, improving industrial efficiency and providing real-time visibility, interoperability and control of electricity grids as more renewable energy is integrated. The roadmap is based on three pillars: (1) integrating data centres into the energy system in a sustainable and transparent way; (2) accelerating the uptake of digital and AI solutions, including improving grid-enhancing technologies and the faster rollout of smart meters and (3) developing a framework for secure and efficient cross-border data sharing. These pillars are complemented by further actions on trust in AI solutions, cybersecurity of critical energy infrastructure, tailored digital skills for the energy industry and international co-operation.
NEWS
The European Commission has published a roadmap to phase out animal testing in chemical safety assessments. In support of the initiative, the European Chemicals Agency (ECHA) has announced a new platform to advance the development and regulatory use of alternative methods.
NEWS
The European Commission has adopted the second Work Programme for the digital part of the Connecting Europe Facility (CEF) Digital, backed by €865m for 2024–2027. The second Work Programme will focus on the deployment of 5G infrastructure in Europe, the deployment of significant upgrade of backbone networks such as quantum communication networks and submarine cables, and the deployment of operational digital platforms for transport of energy infrastructures. It also aims to stimulate the competitiveness of the European digital ecosystem and contribute to leveraging public and private resources to tackle the investment gap that hinders the rollout of high-performance networks. The Commission has confirmed that the fourth call under the CEF Digital programme will be launched shortly.
NEWS
The European Commission has published the second draft of the Code of Practice on Transparency of AI-Generated Content to support compliance with the transparency obligations in Article 50(2), (4) and (5) of the EU AI Act. The draft sets out voluntary commitments for providers of generative AI systems and deployers of AI systems to ensure that AI-generated or manipulated content is appropriately marked, detectable and clearly disclosed to natural persons, with the aim of promoting trustworthy and human-centric AI while safeguarding fundamental rights and supporting innovation. For providers, it establishes a multi-layered marking approach requiring at least two machine-readable techniques, notably digitally signed metadata and imperceptible watermarking, supported by detection mechanisms and requirements of effectiveness, reliability, robustness and interoperability. For deployers, it requires clear and distinguishable disclosure of deepfakes and certain AI-generated or manipulated text published on matters of public interest, including through an ‘AI’ icon or equivalent label meeting defined design and placement standards, and sets out proportionate rules for artistic and similar works, internal compliance measures, and conditions for reliance on the exemption where human review and editorial responsibility are exercised.
NEWS
The European Commission has released the second draft of the General-Purpose AI Code of Practice, incorporating feedback from the first draft published on 14 November 2024. This iteration outlines transparency and copyright obligations for all providers, as well as systemic risk assessment and mitigation measures for advanced models. The draft aligns with AI Act obligations and introduces a new structure focusing on objectives, commitments, and measures, along with preliminary Key Performance Indicators. The Commission has scheduled further working group meetings and workshops to refine the Code. The third draft of the Code of Practice can be expected for the week of 17 February 2025.
NEWS
The European Commission has issued a statement supporting the G7 digital and tech ministers' agreement on a common set of principles designed to create a safer and more secure digital space for minors. This agreement is directly inspired by the EU's pioneering approach to online child safety, reflecting established EU measures such as the EU Digital Services Act, its guidelines on minor protection, the Better Internet for Kids Strategy (BIK+), the EU AI Act and the action plan against cyberbullying. The seven principles integrate robust enforcement to hold platforms accountable with a societal effort to enhance media literacy and raise awareness. They emphasise effective risk management and mitigation integrated into safety-by-design approaches while ensuring privacy-preserving age assurance solutions to bar minors from accessing age-restricted services. They call for the implementation of privacy and safety features for minors’ accounts, including recommendation systems designed to minimise excessive online engagement. Additionally, they encourage strict measures to halt the generation and distribution of harmful content, such as child sexual abuse material and non-consensual intimate images, including those produced by artificial intelligence. Other key elements include accessible, interoperable parental tools and comprehensive digital literacy programs for parents, teachers and minors to better recognise digital risks, as well as fostering cooperation between digital services and researchers through enhanced data sharing to bolster online protections for minors. The G7 ministers have called for digital service providers to convert these principles into practical actions following an action plan with several specific measures already outlined.
NEWS
The European Commission has published a study assessing the application of selected provisions of the Intellectual Property Rights Enforcement Directive 2004/48/EC (IPRED) across the EU. The study focuses on five priority areas: (1) the proportionality principle in patent injunction cases; (2) the role and impact of Patent Assertion Entities in the EU; (3) the use of dynamic blocking injunctions for industrial property rights; (4) the interaction between the right of information and data protection rules and (5) the costs associated with the destruction of IP-infringing goods. The findings identify variations in IPRED application across EU member states, with national courts often applying limited proportionality assessments in patent injunction cases and adopting varying approaches to dynamic blocking injunctions and information sharing. The study also notes that high enforcement costs, particularly for storage and destruction of infringing goods, may deter SMEs and smaller rightsholders from pursuing enforcement action. The analysis draws on legislation and case law from nine EU countries, complemented by EU-wide stakeholder surveys and expert consultations.
NEWS
The European Commission's Directorate-General for Health and Food Safety (DG Sante) has published a comprehensive study examining barriers to artificial intelligence (AI) deployment in healthcare systems across the EU. The report identifies legal and regulatory complexities as key challenges, alongside technical, organisational and social barriers. It proposes a monitoring framework for tracking AI integration while balancing innovation with patient rights protection. The study provides strategies from global hospital implementations to guide EU-wide deployment of AI healthcare solutions.
NEWS
The European Commission has published a summary and the individual contributions received in response to its consultation on the ongoing review of the EU Digital Markets Act (DMA). The Commission notes that many respondents support the DMA’s objectives of ensuring fair and contestable digital markets, but also highlight implementation challenges and identify areas for improvement. Many respondents call for greater interoperability, improved data access and data portability, increased support for SMEs, and an expansion of the DMA’s scope—particularly in relation to AI and cloud services. Some support coverage under existing core platform service (CPS) categories or the creation of new standalone CPSs, while others caution against premature expansion. Gatekeepers raised concerns about proportionality, compliance costs and potential impacts on innovation and user experience. The Commission confirmed that its assessment of the consultation responses, alongside the call for evidence and the dedicated AI consultation, will feed into its review report, which is due to be presented by 3 May 2026 to the European Parliament, the Council and the European Economic and Social Committee.
NEWS
The European Commission’s Directorate-General for Taxation and Customs Union has published a technical study on indirect emissions under the EU Carbon Border Adjustment Mechanism (EU CBAM). The study is intended to support the implementation and potential future development of the mechanism in relation to indirect emissions embedded in goods imported from third countries.