Doing Business in the European Union | Reporting Systems and the Importance of Culture & Language
Doing Business in the European Union | EU Directive, Following Up With The Whistleblower
Trade secret litigation after the Defend Trade Secrets Act
The Government’s recently published Sustainability Disclosure Requirements (SDR): Implementation Update 2024 outlines the timeframes and next steps for each of the core elements of SDR, first proposed in 2021 to provide a...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 17 December 2021 deadline for EU Member States to implement the EU Whistleblowing Directive into national laws is fast approaching. Private sector organisations in the European Union with 250 or more workers (and certain...more
The Directive’s robust prohibitions against retaliation for covered persons—including both attempts and threats— is meticulously outlined in Article 19....more
Article 17 of the Directive explicitly incorporates the provisions of Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data (“GDPR”) to the handling of such data in relation...more
On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more
Global companies face a number of challenges and a myriad of regulatory obligations. In December 2019, the EU adopted a directive to promote and protect persons who report violations of law....more
The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more
Electronic money or e-money has been subject to regulation in the EU since April 2002 when the first Electronic Money Directive 2000/46/EC (“EMD1”) established the regulatory framework. However, there have been difficulties...more
On 7 January 2020, Directive (EU) 2019/2161 (the "Directive") came into force, setting into motion a swathe of measures aimed at modernizing the existing consumer protection rules, bolstering the level of protection available...more
Update confirms the introduction of an active “duty of care” and a dedicated regulator, as part of a comprehensive new online regulatory regime. Following a wave of commentary from industry, the social sector, and other...more
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more
The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...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
In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...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
Pre-marketing and reverse solicitation of alternative investment funds in Europe. The European Commission originally announced a proposal for a supplementary AIFM Directive (AIFMD 2) approximately sixteen months ago. After...more
The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the...more
What do people see when they look at a piece of fine art—such as a painting by Cezanne, a sculpture by Giacometti, or a three-dimensional combine by Rauschenberg? To a great extent, it depends on who’s doing the looking. An...more
It's been a year since the European Commission published its Fifth Report on the application of the European Product Liability Directive (the "Directive") and set up expert panels to develop its thinking on next policy steps....more
Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more
The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more
On Jan. 9, 2019, both the European Securities and Markets Authority (ESMA) and the European Banking Authority (EBA) published a report on crypto-assets....more
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more
Insurance Guarantee Schemes (“IGS“) provide last resort protection to consumers in the event that their insurance company becomes insolvent or simply unable to fulfill their contractual commitments....more