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Manufacturers Regulatory Oversight European Commission

K&L Gates LLP

Brussels Regulatory Brief: June 2024

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Antitrust and Competition - The European Commission to Take Action to Address Territorial Supply Constraints - On 24 May 2024, the EU Commissioner for Competition, Margrethe Vestager, announced that the European Commission...more

K&L Gates LLP

Brussels Regulatory Brief: April 2024

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Antitrust and Competition - European Commission Charges Company with Providing Incorrect, Incomplete, and Misleading Information During a Merger Control Proceeding - On 19 March 2024, the European Commission (Commission) sent...more

K&L Gates LLP

Commission Adopts European Defence Industrial Strategy Proposing Additional Funding for Defence Responsiveness

K&L Gates LLP on

Introduction - On 5 March, the European Commission (Commission) adopted the European Defence Industrial Strategy (EDIS) and proposed a regulation establishing the European Defence Industry Programme (EDIP)....more

Baker Donelson

Who's Who under the EU AI Act: Spotlight on Key Actors

Baker Donelson on

Who will play the leading role if we make a new series about AI? If you interview Steven Spielberg, Sundar Pichai, and Sam Altman, you might receive three distinct ideas ranging from the 2001 classic "AI: Artificial...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

K&L Gates LLP on

Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Hogan Lovells

A brave new world of AI liability in the EU

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Manufacturers and other stakeholders contemplating the use of AI-enabled products and services should be mindful of new rules proposed by the European Commission (EC) to address product liability claims related to AI systems....more

Hogan Lovells

Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

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In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...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

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....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

Implications of European Commission’s proposal for a Regulation to modify existing EU rules to allow manufacturers to apply for...

Hogan Lovells on

On 4 June 2018, the European Commission adopted a proposal for a Regulation to modify existing EU rules to allow manufacturers of vehicles to obtain new approvals from the 27 EU Member States who will remain post-Brexit to...more

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