The European Commission has announced plans to adopt a delegated act establishing rules for digital product passport (DPP) service providers, a crucial component of the wider DPP governance framework. This initiative stems from the Ecodesign for Sustainable Products Regulation, which introduced the DPP as a tool to enhance access to digital information on product sustainability, circularity, and legal compliance. The Commission has scheduled a call for evidence from 12 November to 10 December 2024, followed by a public consultation in the fourth quarter of 2024. The final adoption of the delegated act is anticipated in the fourth quarter of 2025, marking a significant step towards implementing the DPP system within the EU's sustainable products strategy.

The European Commission has amended the Commission Delegated Directive 2013/34/EU (the Accounting Directive) to change the size criteria for micro, small, medium-sized (SME) and large entities to account for the impact of inflation. These increased adjustments now mean that micro entities and SMEs will no longer be subject to various EU economic and sustainability reporting requirements that are applicable to larger companies. Member States are to apply the new thresholds at the latest from financial year 2024, with the option to opt for early application for financial year 2023.

The European Commission has provided guidance on the gradual roll-out of EUDAMED, the centralised database for medical devices. The Commission has clarified that under the revised Article 123(3)(d) of Regulation (EU) 2017/745 (the Medical Devices Regulation(MDR) and Article 113(3)(e) of Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices (the IVDR), obligations related to each EUDAMED module will become applicable six months after the publication of a notice confirming the module's functionality in the Official Journal.

The European Commission has sent a request for information (RFI) to TikTok under the EU Digital Services Act (DSA), focusing on the platform's management of information manipulation risks during the Romanian elections. The Commission has asked TikTok to provide detailed information on its analysis and mitigation of inauthentic or automated exploitation risks and those stemming from its recommender systems.

The European Commission has issued a 'retention order' to TikTok under the Digital Services Act (DSA), ordering TikTok to preserve data under the Digital Services Act due to potential risks to EU electoral processes and civic discourse. This action, linked to concerns about foreign interference in Romanian elections, requires TikTok to keep information on its systems and efforts against inauthentic behaviour. The order covers EU elections from 24 November 2024 to 31 March 2025.

EU Law analysis: The European Commission has issued long awaited comprehensive guidelines on the definition of AI systems, as established by Regulation (EU) 2024/1689 (EU AI Act). With these practical guidelines, the Commission aims to assist providers, deployers, importers, distributors of AI systems in determining whether a system constitutes an AI system within the meaning of the EU AI Act, thereby facilitating the effective application and enforcement of that Act. The definition of AI systems entered into force on 2 February 2025. Dóra Petrányi, Central Eastern Europe managing director and co-head of the Technology, Media and Communications Group, Katalin Horváth and Ian Stevens, partners at CMS, analyse the key elements of the AI system definition.

The European Commission's IVD expert panel has released new scientific advice regarding SARS-CoV-2, indicating that the virus no longer poses a significant mortality risk for the general European population. This development may impact the classification of SARS-CoV-2 tests under Regulation (EU) 2017/746. Manufacturers are advised to evaluate how this affects their devices and consult with notified bodies regarding potential changes in risk classification. Devices may continue to be marketed under their current risk class, provided they meet all requisite standards. The Medical Device Coordination Group (MDCG) is updating its guidance on IVD classification to reflect this advice, though it remains non-binding. Manufacturers must determine risk classification on a case-by-case basis, considering the device's intended purpose and target population, as well as the current epidemiological context.

The European Commission has launched the 2024 small and medium-sized enterprises (SME) Fund to provide SMEs with financial support for additional services to manage and protect their intellectual property (IP) rights. The SME Fund is a grant scheme designed to help SMEs protect their IP rights–including patents, trademarks, industrial designs and new plant varieties–by providing financial support. The SME Fund can also finance a broad assessment of the IP needs of the SMEs, considering the innovative potential of their intangible assets. The stepping up in efforts to preserve SMEs’ intangible assets follows the great success of the 2023 Fund: 34,801 applications for 22,899 SMEs financially supported to expand and to become more attractive for investment. This represents a 55% increase on 2022.

The European Commission has launched an Ecodesign Forum to support the implementation of Regulation (EU) 2024/1781 (the Ecodesign for Sustainable Products Regulation (ESPR)). The Ecodesign Forum will consist of key stakeholders from industry, academia, civil society, and experts appointed by Member States, who will be consulted on the development of ecodesign requirements, the preparation of ESPR working plans, and energy-labelling requirements for energy-related products. The Commission is accepting applications to join the Ecodesign Forum until 5 December 2024. Representatives of Member States and other public entities will be appointed through direct invitation from the Commission.

The European Commission has launched a call for setting up AI factories which will help AI developers train their large generative AI models by using European high-performance computing supercomputers and providing access to data, computing and storage devices. The AI factories, which are a part of the AI innovation package announced in January 2024, will connect the AI initiatives of Member States and advance the development of AI industrial and scientific applications in key European sectors including healthcare, automotive  and transport, agri tech, energy etc. The first deadline for this call is 4 November 2025, with subsequent cut-off dates announced every three months as long as funds are available. The final deadline is 31 December 2025.

The European Commission has launched a call for evidence on the current competition issues in vertical relationships in the motor vehicle distribution and after-sales markets to help evaluate and reassess the performance of Regulation (EU) 461/2010, the Motor Vehicles Block Exemption Regulation (MVBER). The evaluation will focus on the function of the MVBER since the Commission extended the Regulation in April 2023 to 31 May 2028, and the amendments to the guidance provided in the corresponding Commission Notice (Supplementary Guidelines). The deadline for response is 24 June 2024 (midnight Brussels time).

The European Commission has launched a call for evidence regarding its planned EU cardiovascular health plan. The EU Cardiovascular Health Plan is a strategic initiative aimed at reducing the burden of cardiovascular diseases across the European Union. It seeks to improve public health outcomes through prevention, early detection and personalised treatment, while also enhancing innovation and competitiveness within the EU health sector. The plan will support Member States in achieving Sustainable Development Goals, particularly those related to non-communicable diseases and will address health inequalities across regions, genders and vulnerable populations. It will also help tackle the research and innovation gap by promoting evidence-based policies and high-quality health products.