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 code covers transparency, copyright compliance, and management of systemic risks for providers of GPAI models....more
On January 17, 2024, the Council of the European Union (Council) and the European Parliament (Parliament) announced that a political agreement had been reached on (i) a new Regulation setting forth a single anti-money...more
Welcome to the second edition of our Horizon Scan, where we focus on some of the principal recent and expected developments and changes that we expect to be of interest to those in the non-listed funds sector. We have grouped...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
On 17 November 2020, the European Commission published an inception impact assessment for a revision of the Tissue Directive and the Blood Directive. With this proposal, the European Commission aims to tackle existing...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
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
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
On July 12, 2019, the following new EU directive and regulation on cross-border distribution were published in the Official Journal of the European Union...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
Following the enactment of the Act amending the Industrial Property Law of 20 February 2019 which implements the Directive of the European Parliament and of the Council (EU) 2015/2436 of 16 December 2015, the Polish Patent...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
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more
The European Union’s Fifth Anti-Money Laundering Directive recently became binding upon EU Member States. This latest directive must be enacted by member states by January 10, 2020. ...more
On 9 August 2018, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical...more
How big is the Internet of Things (IoT)? It’s likely that there will be tens of billions of connected devices in use by 2020. As this massive network of “things” keeps expanding, so do the number of questions about...more
The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market. ...more
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more
Looking Out for Main Street: SEC Focuses on Retail, Cybersecurity and Cryptocurrency - The Commissioners and senior officials of the Securities and Exchange Commission ("SEC" or "Commission") addressed the public on...more