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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Latham & Watkins LLP

EU AI Act: GPAI Model Obligations in Force and Final GPAI Code of Practice in Place

Latham & Watkins LLP on

The code covers transparency, copyright compliance, and management of systemic risks for providers of GPAI models....more

Mayer Brown

EU Institutions Reach Political Agreements On Anti-Money Laundering and Countering the Financing of Terrorism Package

Mayer Brown on

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

Goodwin

Horizon Scan for Private Investment Funds: Key Recent and Expected Funds, Regulatory and Tax Developments to Look Out For - May...

Goodwin on

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

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

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

Hogan Lovells

Towards a revision of current tissue, blood, and cells legislation in the European Union

Hogan Lovells on

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

Hogan Lovells

European Commission announced its plan to postpone the implementation of the MDR by one year

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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

Hogan Lovells

Gearing up for enhanced consumer protection: the impact of the EU's new rules

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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

Hogan Lovells

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

Hogan Lovells on

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

Hogan Lovells

Publication of rules on designation of expert panels under the Medical Devices Regulations

Hogan Lovells on

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

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on

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

Orrick, Herrington & Sutcliffe LLP

AIFMD: New Pre-Marketing Rules

Orrick, Herrington & Sutcliffe LLP on

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

Hogan Lovells

European Product Liability Directive: Stay tuned, guidance is around the corner

Hogan Lovells on

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

Hogan Lovells

Polish Patent Office publishes guidelines on new types of trademarks

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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

Hogan Lovells

New Belgian legislation on the distribution of medical devices

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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

Hogan Lovells

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

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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

Herbert Smith Freehills Kramer

ESMA and EBA Assess Whether Crypto-Assets Are Regulated Under Existing EU Rules and Advise the European Commission to Consider an...

Herbert Smith Freehills Kramer on

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

Hogan Lovells

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

Hogan Lovells on

Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Hogan Lovells

Too soon to harmonize EU Insurance Guarantee Schemes?

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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

Hogan Lovells

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

Hogan Lovells on

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

K2 Integrity

Virtual Currency Regulation: It’s Here. It’s There. It’s Everywhere.

K2 Integrity on

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

Hogan Lovells

MDR and IVDR: the European Commission published some guidance documents

Hogan Lovells on

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

Hogan Lovells

How the Internet of Things could redefine product safety and liability in the EU

Hogan Lovells on

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

Hogan Lovells

“New Deal for Consumers” – draft package adopted by the European Commission

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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

Hogan Lovells

Digital Health: CE marking of medical devices

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In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more

Orrick, Herrington & Sutcliffe LLP

Orrick's Financial Industry Week In Review

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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

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