General principles and regulation

General principles

EU competition law and extraterritoriality

The European Commission jurisdiction to prosecute antitrust infringements committed outside of the European Economic Area (EEA) by non-EEA-based undertakings has been the subject of much debate.

Although EU Treaties do not provide specific guidance on the extraterritorial reach of EU competition rules, the Court of Justice has over time devised a number of tests to determine whether, in a given case, the Commission has appropriate jurisdiction. These tests are:

•
the single economic entity doctrine that enables the Commission to assert jurisdiction over the parent company of a subsidiary located and engaged in illegal activity within the EEA
•
the implementation doctrine that focuses on the extent to which the anti-competitive conduct has been implemented in the EEA, and
•
the qualified effects doctrine, whereby the Commission needs to show that the conduct had substantial, immediate, and foreseeable effects in the EEA.

For more information, see Practice Note: Extraterritorial application of EU competition law.

Effect on trade

‘Effect on trade’ is a jurisdictional test which determines whether EU or national law is applicable to potentially anti-competitive

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest EU Law News

SRB publishes operational guidance on bank resolvability testing framework

The Single Resolution Board (SRB) has published its final operational guidance on Resolvability Testing for Banks, following a public consultation involving the banking associations and individual institutions. The guidance outlines a structured framework for banks to assess their crisis readiness through a Multi-Annual Testing Programme, aligned with the revised European Banking Authority Guidelines and the Single Resolution Mechanism Vision 2028. It details expectations for testing methods, governance, environments, and deliverables, applying proportionality based on institutional complexity. In response to stakeholder feedback, the SRB clarified and simplified requirements, including the use of production environments, streamlined templates, and flexible scheduling. The guidance aims to ensure that resolution strategies are operationally viable, with banks, national authorities, and the SRB jointly advancing preparedness for potential resolution scenarios.

Industry Groups Urge EU to Broaden Access to Electronic Instructions for Everyday Medical Devices

MedTech Europe, along with Eurom and EuromContact, has called on the European Union to broaden the scope of electronic instructions for use (eIFUs) so that they can apply to certain medical devices intended for non-professional users. The trade groups argue that eIFUs are suitable in cases where a healthcare professional provides initial guidance at the first use of a device and where repeated use allows individuals to gain confidence and proficiency. They highlight products such as contact lenses, urinary catheters and diabetes management devices as prime examples that would benefit from this approach. According to the groups, expanding the use of eIFUs would not only improve accessibility of health information but also help to reduce the environmental footprint of these medical products.

MedTech Europe leads industry call for EU to provide medical device regulatory relief by early 2026

MedTech Europe, together with 35 national associations, has urged the European Commission to take swift action on regulatory challenges affecting the medical device and diagnostic sectors. While EU officials are already collecting evidence to support future reforms of the medical device and in vitro diagnostic regulations, which are meant to simplify and improve efficiency, the signatories of the open letter argue that immediate relief is also essential. They call for a combination of short-term measures alongside longer-term legislative reforms. In particular, the letter asks for an implementing act to standardize the work of notified bodies, pilot projects for regulatory pathways covering orphan, pediatric, and breakthrough devices, and a targeted delay of re-certification requirements for certain products. According to MedTech Europe, harmonizing rules for notified bodies would help reduce duplication, speed up assessments, and ease the overall regulatory burden. The proposed postponement of re-certification deadlines is seen as necessary to avoid bottlenecks that could disrupt the supply of devices ahead of 2028. Looking further ahead, the associations want amendments to both MDR and IVDR that reflect the specific needs of each sector, alongside the creation of a single governance structure to oversee notified bodies and the CE-marking system, which they consider vital to the future of European medical technology regulation.

Industry groups call for EU Critical Medicines Act to address supply chain vulnerabilities

The European Federation of Pharmaceutical Industries and Associations (EFPIA), alongside Medicines for Europe and the European Fine Chemicals Group (EFCG), has called on the EU to legislate a Critical Medicines Act to address systemic shortages of medicines and active pharmaceutical ingredients (APIs). At a European Parliament event hosted by MEPs Tomislav Sokol (EPP) and Vlad Vasile Voiculescu (RE), industry representatives highlighted the impact of COVID-19, geopolitical tensions, inflation and reliance on a limited number of suppliers. They emphasised the need for strategic autonomy in healthcare and a harmonised EU approach to strengthen supply chains and manufacturing capacity. Speakers also noted that pricing pressures have contributed to supply chain fragility and called for alignment between EU-level intentions and national implementation.

General principles and regulation