EU Law analysis: The European Commission has published its long-awaited proposal for a Regulation on public contracts and concessions. The proposal repeals the three 2014 Directives and replaces them with a single, directly applicable Regulation, marking the most significant overhaul of EU public procurement law in over a decade. Produced by the public procurement team of Loyens & Loeff: Valentijn De Boe (partner, Brussels), Marc Custers (counsel, Amsterdam), Aude Van den Bussche (associate, Brussels), Ambre Riley (associate, Luxembourg), Maartje Jongejans (associate, Amsterdam) and Jan-Baptist Lemaire (associate, Brussels).

MLex: Representatives of EU Parliament and Member States chose the German city of Frankfurt to host the future EU anti-money laundering authority (AMLA), which will start work in 2025.

The Medical Device Coordination Group (MDCG) has published guidance on the clinical evaluation of orphan medical devices. Regulation 2017/745, the Medical Devices Regulations (MDR), has increased the level of clinical evidence that is required to place medical devices on the market, including for orphan medical devices (ie devices or accessories for rare diseases). This can be problematic for orphan devices which have small patient populations to satisfy the higher clinical evidence threshold and the guidance recognises that manufacturers may need to rely more on postmarket studies and non-clinical data to support such products. The MDCG has published this guidance aimed at manufacturers and Notified Bodies detailing considerations for determining when a medical device or an accessory for a medical device should be regarded as ‘orphan device’ and the potentially limited evidence needed to determine whether it has proven to be safe and effective, including procedural information for the application process in Part B.

Law360: A fresh set of European Union customs rules entered into force on 21 September 2026 to address new trade challenges, including the rapid expansion of e-commerce.

MLex New ‘ecodesign’ rules for EU products, to make them more sustainable, were approved by the European Parliament today, and will now be voted on by national governments in the Council of the EU before becoming EU law. A digital ‘product passport’ and a ban on destroying unsold textiles and footwear are two features of the new legislation.

Law360: On 3 June 2024, the European Data Protection Supervisor issued its first guidelines regarding generative Artificial Intelligence (AI).

MLex: EU governments, on 4 May 2024, agreed new rules, known as the FASTER initiative, that aim to make withholding tax procedures safer and more efficient for cross-border investors, national tax authorities and financial entities. The initiative will introduce a common EU digital tax residence certificate, provide Member States with two fast-track relief and refund procedures, and set a standardised reporting mechanism for banks and investment platforms. The Council of the EU acted as sole legislator, but will consult EU lawmakers again after making changes to the proposed Directive. It will enter into force after adoption by the Council and publication in the EU's Official Journal. Statement follows. The agreed Directive is attached.

The European Commission has adopted a proposal laying out a new EU-UK joint solution under the Windsor Framework on the use of tariff-rate quotas (TRQs) by Northern Ireland businesses. The proposal adopted includes a suggestion to revise the section on 'goods not at risk' of the decision of the Joint Committee of the EU-UK Withdrawal Agreement laying down arrangements relating to the Windsor Framework. The solution will ensure that Northern Ireland businesses are able to utilise the UK TRQs for imports from third countries of various agri-food products, for example, New Zealand lamb. The solution is based on the needs of Northern Ireland businesses and will guarantee the protection of the EU Single Market.

In a new version of the main EU Settlement Scheme (EUSS) caseworker guidance dated 16 January 2024 (EU Settlement Scheme: EU, other EEA and Swiss citizens and their family members, version 22), the Home Office has added in at p. 50 two new sets of circumstances which might provide reasonable grounds for a late application to the Scheme. Since changes to the Immigration Rules on validity on 9 August 2023 and related changes to the guidance there has been a big rise in the numbers of applications rejected on these grounds. The new circumstances are where a person has provided information and evidence that they had either a reasonable belief that they did not need to apply earlier to the EUSS, or a reasonable basis for being unaware that they needed to apply, and in either case they have now applied without further delay. The guidance gives a range of factors which can be taken into account in this regard (if based on credible information and supporting evidence), and the wording suggests that an application is more likely to be successful if more than one factor is present (although every case must be considered in light of its particular circumstances and the evidence provided).

The FCA has published a new webpage setting out the flexibility for firms in its interest rate ‘stress test’ rule and considering the effect of future rate rises on mortgage affordability.

Law360: In June 2025, the US Department of Justice (DOJ) issued new guidance for prosecutions under the Foreign Corrupt Practices Act (FCPA), ending the enforcement pause ordered by President Donald Trump earlier this year.

Construction analysis: On 3 December 2025 the International Federation of Consulting Engineers (FIDIC) launched its new practice note: FIDIC Practice Note III Decisions: Preparation and Composition. This analysis considers FIDIC’s new guidance on how dispute boards should prepare and write their decisions, which focuses on the production of clear, well-reasoned, contract-compliant decisions within the tight timetable of the DAAB process, and sets out practical procedural, evidential and drafting steps, that will help dispute boards deliver decisions that are efficient, fair and enforceable.