Regulatory Oversight, European Commission, New Guidance

EU Commission – Guidelines on the Scope of the Obligation for GPAI Models under the AI Act

Orrick, Herrington & Sutcliffe LLP on 8/4/2025

The European Commission published guidelines concerning the definition of “general-purpose AI models” (GPAI) under the AI Act and the scope of the Chapter V obligations imposed on providers of these models. The final...more

EPC publishes Guidelines for PSPs joining payment schemes

A&O Shearman on 4/23/2025

The European Payments Council (EPC) has issued Version 7.0 of the Adherence Guide to the EPC Payment Schemes, together with an updated webpage. The updated guide provides guidelines and template application forms for payment...more

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on 12/8/2020

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

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

Hogan Lovells on 1/25/2019

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

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

Hogan Lovells on 1/8/2019

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

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

Hogan Lovells on 11/26/2018

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

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

Hogan Lovells on 10/22/2018

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

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