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Hot Topics in International Trade A Year in Review (Quickly)
The circular economy invites us to fundamentally reconsider our relationship with resources and products. By moving away from the outdated "take-make-dispose" model, companies are embracing a more sustainable approach that...more
The EU Commission has adopted Directive (EU) 2024/2853, which implements a comprehensive overhaul of the 1985 Directive 85/374/EEC on defective product liability (“New PLD”). The new framework, which complements Regulation...more
The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more
The Directive expands the scope of liability to digital products (including AI systems), fulfilment service providers, and online platforms, while reducing the burden of proof for claimants. On 9 December 2024, the new...more
On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....more
The updated Directive aims to modernize the existing liability regime, in particular in the light of past and future technological developments as well as the challenges faced by plaintiffs in proving a claim. According to...more
On October 10, 2024, the Council of the EU adopted the new EU Directive on Liability for Defective Products, which replaces the previously applicable Product Liability Directive of 1985, thereby fundamentally changing the...more
With the deadline for Member States to transpose the European Union’s updated Network and Information Systems Directive (Directive (EU) 2022/2555) (NIS 2 or Directive) into national law, with the Directive having passed on 18...more
This week, the European Union made a significant breakthrough towards its goal of overhauling the 40-year-old Product Liability Directive for the demands of the “digital” age and modern economy. To amend the directive, the...more
A joint Committee of the European Parliament consisting of the Internal Market and Consumer Protection Committee (“IMCO”) and the Committee on Legal Affairs (“JURI”) approved their position on the European Commission's...more
The EU AI Act, which is progressing towards adoption by the end of 2023, will be complemented by an update to the European civil liability rules applicable to AI-related claims. Towards the end of 2022, the EU Commission...more
The EU Commission is currently proposing a wide range of measures to achieve the goals of the European Green Deal to become climate neutral by 2050. At the same time it has a clear tendency to strengthen consumer rights. In...more
The EU Commission is currently proposing a wide range of measures to achieve the goals of the European Green Deal to become climate neutral by 2050 and to strengthen consumer rights simultaneously. In this context it has now...more
On Thursday, the EU Parliament approved the European Commission’s proposal to extend the transition periods of the Medical Device Regulation (EU) 2017/745 (MDR). As the Council had already signalled its support, the proposal...more
On Friday 9 December 2022, the European Commission proposed to extend the transition deadline in the Medical Device Regulation (EU) 2017/745 (MDR). According to the European Commissioner for Health and Food Safety, Stella...more
Injured parties have claimed for a long time that one of the biggest obstacles they face to obtain compensation for damages suffered in product liability cases, is to meet the burden of proof regarding the defectiveness of...more
The directives aim to assist claimants in proving the causation of damages and product defectiveness in complex AI systems, creating legal certainty for providers. On 28 September 2022, the European Commission issued two...more
On Wednesday 28 September, the European Commission released details of its long-awaited proposal for the revision of the 1985 Product Liability Directive (PLD) that introduced a strict liability regime for defective products...more
On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more
On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more
On 9 August 2018, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical...more
How big is the Internet of Things (IoT)? It’s likely that there will be tens of billions of connected devices in use by 2020. As this massive network of “things” keeps expanding, so do the number of questions about...more
The European Commission published two evaluation and fitness check roadmaps in May this year. These roadmaps will assist the Commission in assessing whether the current legislative framework for chemicals, including REACH, is...more