EU regulatory supervision

This subtopic contains the following documents:

Practice Notes

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Introduction to European financial services law and financial services coverage—a brief introduction to EU financial services law, describing the regulatory regime through brief guidance and by means of multiple links to relevant external materials, mainly hosted on EU websites and on the websites of other international institutions and multiple internal links to relevant commentary and analysis
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The application of EU legislation to non-EU EEA states—this Practice Note outlines the history and application of EU legislation to non-EU EEA states
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The European Supervisory Authorities (ESAs) and the European System of Financial Supervision—this Practice Note provides guidance on the European Supervisory Authorities (ESAs), the European Securities and Markets Authority (ESMA), the European Banking Authority (EBA) and the European Insurance and Occupational Pensions Authority (EIOPA), among other things, their roles and general powers to develop draft technical standards, and issue opinions, guidance and recommendations to national

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Latest EU Law News

Amendments to draft Critical Medicines Act proposed to address impact of environmental over-regulation

The European Parliament’s Committee on the Environment, Climate and Food Safety has proposed key amendments to the draft Critical Medicines Act (CMA) to address the unintended consequences of overlapping environmental and chemical regulations on medicine supply. The committee acknowledges the importance of the EU’s environmental goals but warns that stricter rules—such as those on emissions, wastewater treatment, or substance restrictions—could raise production costs or push pharmaceutical manufacturing outside the EU. This could worsen medicine shortages and undermine the region’s competitiveness.

MedTech Europe publishes Reflection Paper calling on reform of diagnostic device sampling for certification

MedTech Europe has published a Reflection Paper calling on the Medical Device Coordination Group (MDCG) to adopt a risk-based, rather than quota-based, sampling approach for Class B and Class C devices to reduce the burden stemming from duplicative sampling and focus the resources of the system on higher risk devices. The industry body emphasises that in vitro diagnostic (IVD) device manufacturers have increased technical documentation and administrative burden under the Regulation (EU) 2017/746 (IVDR). Notified Bodies dedicate most of their time in sampling lower risk Class B and Class C devices, rather than highest risk Class D devices. Class B and C diagnostics together make up over 90% of the EU IVD market. The Paper notes that the average number of samples taken under IVDR is more than double that under the Medical Devices Regulation (MDR), due to broader scope codes and more grouping categories for IVDs. MedTech Europe in this Paper argues that the current system leads to repetitive sampling of the same devices, particularly for SMEs with limited portfolios, offering little added value in terms of safety or performance assurance. The Paper argues that the mandated 15% sampling rate for technical documentation per certification cycle is disproportionate, especially when compared to the 100% review requirement for the highest-risk Class D devices. This quota-based system imposes a significant financial and operational burden on manufacturers, with average costs per technical file review nearing €38,000. MedTech Europe proposes a shift to a risk-based sampling model. This seems to take a page from the UK which just had the UK Government respond to a public consultation in support of future regulation that will create a more proportionate risk-based approach to diagnostic device certification that would, in particular, mean that certification of Class B IVDs for the Great Britain market would require UKCA self-declaration and ISO 13485 quality management system (QMS) certification. MedTech Europe proposes to eliminate automatic quotas for Class B devices during surveillance, reducing sampling for Class C devices to 5%, and applying a maximum of 5% sampling during initial certification for devices with stable post-market surveillance. Simulations in the paper show that such an approach would significantly reduce the total cost burden on the sector without compromising safety. The paper calls for the MDCG to revise its guidance to reflect this more proportionate, risk-based strategy

EIOPA's July 2025 Insurance Risk Dashboard shows stable sector with areas of concern

The European Insurance and Occupational Pensions Authority (EIOPA) has published its July 2025 Insurance Risk Dashboard, based on Q1 2025 Solvency II data and Q2 2025 market data from 96 insurance groups and 2116 solo insurance undertakings. The report indicates stable medium-level risks across the European insurance sector, with strong capitalisation and improved non-life underwriting results. However, EIOPA flags concerns in market risks due to fixed income volatility, while cyber and ESG risks show an upward trend. The assessment highlights ongoing challenges from geopolitical tensions and trade uncertainties.

EU Law weekly highlights—31 July 2025

This week's edition of EU Law weekly highlights includes analyses on the Court of Justice’s ruling in CeramTev v Coorstek that held that the absolute grounds for invalidity under Regulation (EC) 207/2009 are autonomous but not mutually exclusive, the Unified Patent Court’s first injunction covering UK in Kodak case, the EU-US trade deal on 15% baseline tariff, the Commission’s guidelines for the protection of minors online under the EU Digital Services Act (EU DSA) and the Commission’s guidelines on the scope of obligations for general-purpose AI models. In addition this week, the European Parliament's Committee on Economic and Monetary Affairs adopted an opinion proposing significant amendments to EU corporate sustainability reporting requirements, the Agency for the Cooperation of Energy Regulators approved a new methodology for assessing national electricity flexibility needs, further, the Commission published a recommendation on voluntary sustainability reporting for SMEs, launched a call for evidence for an integrated framework for climate resilience and risk management across the EU, published guidelines for green bond disclosure templates, initiated the second stage of social partner consultations on proposed EU-level regulation of telework rights and the right to disconnect, and issued preliminary findings indicating that Temu, an online marketplace, may be in breach of the EU DSA.