Refine By
Clear all filter
About 92251 results for "*"
NEWS
EU analysis: It promises a lot but received mixed views: the EU Gigabit Infrastructure Act (EU GIA) will be fully applicable from 12 November 2025 and only time will tell if it can deliver in creating a regulatory environment for faster, cheaper, and simpler rollout of Gigabit networks, addressing hurdles like expensive and complex procedures for network deployment. Francesco Liberatore and Lea Voss of Squire Patton Boggs considers the background of the EU GIA, what’s new under the Act and reactions to the EU GIA.
Q&As
Section 251A of the Insolvency Act 1986 (IA 1986) provides for a debt relief order (DRO) to apply to qualifying debts, defined as unsecured debts for a liquidated sum payable immediately or at some certain future time. The application for a DRO must include a list of the qualifying debts to which the debtor is subject at the date of the application under IA 1985, s 251B(2). When the DRO is made, a moratorium commences that prevents any of the creditors specified in the application for the DRO from taking legal action against the debtor for payment of their debt. If the DRO was successful,
PRACTICE NOTES
This Practice Note tracks the progress of amending legislation, implementing acts, key guidance and initiatives introduced to assist stakeholders in implementing the EU regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) set out in Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)) (together the MD Regulations) as they apply to all EU Member States and Norway, Iceland, Liechtenstein and Turkey. For an overview of the MD Regulations and their requirements, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. This tracker is based on the information available on the European Commission—Public Health website—Medical Devices sector, which includes: • the guidance documents endorsed by the Medical Device Coordination Group (MDCG) • the MDCG ongoing guidance documents • the MDR and IVDR implementing measures rolling plan (the rolling plan) • the MDR/IVDR roadmap (dated November 2017), produced by the competent authorities for medical devices project (CAMD) and the Commission
PRACTICE NOTES
STOP PRESS: Regulation (EU) 2026/1744 amending Regulation (EU) 2024/1689, Regulation (EU) 2018/1139 and Regulation (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) was published in the Official Journal on 24 July 2026 and entered into force on 27 July 2026. This Practice Note will be updated shortly to reflect amendments to Regulation (EU) 2024/1689, the EU Artificial Intelligence Act. For further information on the changes introduced by the Digital Omnibus on AI, see Practice Note: EU Digital Omnibus—tracker and News Analysis: Digital Omnibus proposal—re-writing the EU's digital rulebook. This Practice Note provides an overview of the objectives and scope of Regulation (EU) 2023/1230 on machinery also known as the EU Machinery Regulation (EU MR). The EU MR requires manufacturers and other market participants involved in the production of machinery and related products to adhere to various health and safety requirements. This document describes the key obligations of manufacturers, importers and distributors (as well as other individuals who may
PRACTICE NOTES
This Practice Note considers the European database on medical devices (EUDAMED) and the obligations of economic operators, such as manufacturers, distributors and importers of medical devices, under Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). For information on: • key provisions of the MDR and IVDR, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation • scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies • clinical evaluation and investigation of devices, see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU • post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU EUDAMED and UDI system The European Commission has been tasked with expanding Eudamed2, the database under the MD Directives
PRACTICE NOTES
This Practice Note examines the scope and classification of devices under Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR) (together the MD Regulations), conformity assessment procedures and designation and monitoring of Notified Bodies. For information on: • key provisions of the MDR and IVDR, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation • clinical evaluation and investigation of devices, see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU • post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU • European database on medical devices (EUDAMED) and the obligations of economic operators, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators Devices that fall within the scope of the MD Regulations—Qualification Medical devices General and active implantable medical devices (AIMDs) both
PRACTICE NOTES
The ever-increasing digitalisation of society and the economy has led to a growing risk of exposure to cyber-attacks for organisations. To address this issue, the EU has introduced Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the Union, the Network and Information Security Directive, NIS 2 Directive or NIS 2. NIS 2 is a cybersecurity framework that imposes extensive governance and incident reporting obligations of a range of sectors that have been identified as being of critical importance. It has replaced Directive (EU) 2016/1148, NIS Directive or NIS, (from 18 October 2024) which entered into force in 2016. This results in a significant increase in the cybersecurity standards that apply to organisations that fall within the scope of the Directive. Member States were required to implement NIS 2 into their national laws by 17 October 2024, meaning that organisations needed to prepare to comply during the course of 2023/24. When available, national
PRACTICE NOTES
ARCHIVED: This Practice Note has been archived and is not maintained. It sets out key dates and information relating to the EU’s Network and Information Systems Directive (NIS Directive), Directive (EU) 2016/1148 which is repealed under Directive (EU) 2022/2555 (NIS 2 Directive). It includes strategy documents, consultations, progress reports as well as opinions and guidance issued by a range of organisations on its development, reform and repeal. For the key steps of the legislative procedure of NIS 2 Directive, see Practice Note: The EU NIS 2 Directive—timeline. Key developments Date Institution Summary 10 May 2018 - Commission Implementing Regulation (EU) 2018/151 became directly applicable. 9 May 2018 - The deadline for Member States to transpose the NIS Directive, Directive (EU) 2016/1148, into their national laws. 19 February - Commission Implementing Regulation (EU) 2018/151 entered into force. 30
PRACTICE NOTES
This Practice Note provides an overview of the key amendments introduced to various EU consumer protection legislation by Directive (EU) 2019/2161 (OJ L 328/7), the EU Omnibus Directive. Background In April 2018, the European Commission announced the ‘New Deal for Consumers’ package, which intends to strengthen consumer protection and enforcement across the EU. The New Deal included two proposed Directives, both of which have completed the legislative process: • Directive (EU) 2019/2161 (OJ L 328/7) on the better enforcement and modernisation of EU consumer protection rules, the EU Omnibus Directive • Directive (EU) 2020/1828 (OJ L 409/1) on representative actions for the protection of the collective interests of consumers, the EU Representative Actions Directive The EU Representative Actions Directive repealed and replaces Directive 2009/22/EC, the EU Injunctions Directive, and seeks to improve the tools for stopping illegal practices and facilitates redress for consumers in mass harm situations (ie where many consumers are victims of the same infringement of their rights). The EU Representative Actions Directive entered into force on 24 December 2020. EU Member States
PRACTICE NOTES
This Practice Note provides an overview of Directive (EU) 2024/2831 on improving working conditions in platform work, the EU Platform Work Directive. It covers definitions regarding platform work, a legal presumption as well as rules on the use of algorithms in platform work. Furthermore, the rights of persons performing platform work are considered in conjunction with their enforcement and potential penalties. The Directive consists of three key aspects: the correct classification of the employment status of individuals working with platforms, an increased transparency and accountability of decisions made by algorithms, and an improved enforcement, transparency and traceability of work done through online platforms. Timeline What’s happening When Publication in the Official Journal of the EU 11 November 2024 Entry into force 1 December 2024 Transposition deadline 2 December 2026 Background to the EU Platform Work Directive Platform work is the matching of demand and supply of paid work through an online platform using an algorithm. It can exist in two ways: • online platform work—it operates solely online.
PRACTICE NOTES
STOP PRESS: This Practice Note reflects the current legislative position; however, please note that certain elements will be impacted by the Digital Omnibus proposals published on 19 November 2025 pursuant to the Commission’s ‘simplification’ agenda. For more information, see Practice Note: EU Digital Omnibus—tracker. Regulation (EU) 2019/1150 (OJ L 186/57) on promoting fairness and transparency for business users of online intermediation services and corporate website users of online search engines (also known as the EU Platform-to-business Regulation or EU P2B Regulation) has direct effect in EU Member States from 12 July 2020. This Practice Note sets out the obligations imposed on platform providers and online search engine providers under the EU P2B Regulation and covers the following: • Background • Who does the EU P2B Regulation apply to? • Quick view—platform providers’ obligations under the EU P2B Regulation • Quick view—OSEs’ obligations under the EU P2B Regulation • What are platform providers required to do? • Information to be included in platform providers’ terms and conditions • Platform providers and fair dealing with business users • Complaints
PRACTICE NOTES
This Practice Note summarises the law on defective products under Council Directive 85/374/EEC (the EU Product Liability Directive or EU PLD). The EU PLD imposes liability on producers of defective products. This Practice Note considers what constitutes a defective product under the EU PLD, who in the supply chain may be liable, their degree of liability and any contributory negligence issues, the type of damages that may be awarded and the various defences available to a producer. It considers significant cases of the Court of Justice, looks at reports on the efficacy of the EU PLD. Note that on 18 November 2024, Directive (EU) 2024/2853 on liability for defective products and repealing Council Directive 85/374/EEC (the Revised EU PLD) was published in the OJEU. The Directive is in force from 8 December 2024 and will repeal Directive 85/374/EEC, the EU PLD, on 9 December 2026. EU Member States must transpose the Revised EU PLD by 9 December 2026. For more information on the Revised EU PLD, see Practice Note: The Revised EU Product Liability