Both the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) aim to provide “a robust, transparent, predictable and sustainable regulatory framework that ensures a high level of safety and health while supporting innovation”. However, despite more than six years of implementation, the European and Swiss medical technology industry say that the IVDR and MDR have not achieved their intended objectives. Importantly, they say that there are structural issues in the...

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California Governor Gavin Newsom signed two landmark bills into law on October 7, imposing stringent new requirements on large companies doing business in California to publicly report their annual greenhouse gas (GHG) emissions (Senate Bill (SB) 253) and climate-related financial risks (SB-261). The new laws apply to publicly traded and privately held companies — going well beyond the March 21, 2022, climate disclosure rule proposed by the U.S. Securities and Exchange Commission (SEC) that would apply only to publicly traded companies. One...

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EU completes key "Fit for 55" climate and energy legislation Earlier this week, the Council of the EU adopted the revised Renewable Energy Directive and the RefuelEU Aviation Regulation, completing its momentous “Fit for 55” legislative package. The “Fit for 55” package is a set of legislation that updates EU legislation to ensure EU policies align with the climate goals. It was introduced in July 2021 in response to the EU Climate Law's requirements and updated by the Commission to boost...

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On September 29, 2023, the National Institute of Standards and Technology’s (NIST’s) CHIPS Program Office released a new funding opportunity announcement (FOA) for the construction, expansion, or modernization of facilities for the manufacture and production of semiconductor materials and manufacturing equipment for which the capital investment cost is less than $300 million. Up to $500 million in CHIPS incentives will be awarded under this latest FOA. The latest FOA calls for proposals for construction, expansion, or modernization of the following...

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Since the beginning of 2023, there have been several notable developments in the area of competition law enforcement in the Netherlands. CARTEL ENFORCEMENT The Netherlands Authority for Consumers and Markets (ACM) imposed fines for various cartel infringements in relation to (i) the procurement of industrial eggs, (ii) the e-commerce of televisions and (iii) the manufacturing of traffic signs: Industrial eggs: On 22 December 2022, egg traders Interovo, Wulro and Global received a fine for fixing prices when purchasing industrial eggs from farmers. The ACM...

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On September 26, 2023, the Bureau of Internal Labor Affairs (ILAB) of the U.S. Department of Labor (DOL) issued its 2022 Findings on the Worst Forms of Child Labor Report,1 analyzing the state of child labor in 131 countries and territories, including the United States, and outlining jurisdiction-specific recommendations to combat illegal child labor practices.2 According to the Report, in 2022, there were 160 million children still engaged in child labor, with nearly half working in hazardous conditions, including forced labor and...

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On January 1, 2024 (in approximately five months), the Corporate Transparency Act (CTA) takes effect.  In my previous article , I reviewed why the Act was passed, which entities were affected by the Act, who must file, who is exempt from filing, and when the filings needed to be made.  In this post, I will review what reports need to be filed, the penalties for not filing, and what businesses should do now to prepare for the future. To...

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You may have heard murmurs about significant new prohibitions on non-compete covenants (“non-competes”) and might be concerned about how these developments could threaten your current, past and future deals. In the M&A context, buyers often rely on non-competes as part of a broader strategy to retain the value of the businesses they are purchasing. If any of the target company’s executives, salespeople, owners, developers of IP or others who hold important client relationships or trade secrets can easily leave...

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On 15 September 2023, the Commission Implementing Regulation (EU) 2023/1773 (“Implementing Regulation”) was published in the Official Journal of the EU. The Implementing Regulation governs the application of Regulation (EU) 2023/956 establishing a carbon border adjustment mechanism (“CBAM” or “CBAM-Regulation”) during the transitional period from 1 October 2023 until 31 December 2025. During this transitional period, obligations under the CBAM-Regulation are limited to quarterly reporting duties regarding embedded emissions of relevant goods listed in the Annexes. Obligations to surrender emission certificates will apply from 1...

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Commission calls for risk assessment across critical technologies As part of the broader European Economic Security Strategy, the European Commission has adopted a recommendation advocating for collective risk assessments in four critical technology areas. These include advanced semiconductors, artificial intelligence, quantum computing and biotechnologies. Based on their potential to transform the future of technology; risk of civil-military fusion; and risk of misuse in violation of human rights, these areas were found to face particularly strong risks in relation to technology security and technology...

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