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Brexit - what’s next for medical devices?
  • Hogan Lovells
  • United Kingdom, European Union
  • February 26 2018

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the

Daily Tax Update - January 23, 2018: JCT Estimates Costs of Delaying Health Taxes
  • Steptoe & Johnson LLP
  • USA, European Union
  • January 23 2018

Today, the Joint Committee on Taxation (JCT) released a report (JCX-2-18) on the estimated revenue effects of the continuing resolution (Extension of

Medical devices: European Commission updates Manual on Borderline Products
  • Allen & Overy LLP
  • European Union
  • January 16 2018

The European Commission has issued a revised version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical

Digital Health - The CJEU’ s first decision on standalone software as a medical device
  • Bristows LLP
  • United Kingdom, European Union
  • December 14 2017

Zinovia Chatzidimitriadou On 7 December 2017 the Court of Justice of the European Union (“CJEU”) published its decision on the case C-32916 Snitem

Publication of the notified bodies’ designation codes under the MDR and IVDR
  • Hogan Lovells
  • European Union
  • December 7 2017

The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical

EuropeKey Dates and Roadmap for Implementation of New Rules on Medical Devices
  • Mayer Brown LLP
  • European Union
  • December 1 2017

On November 13, 2017, the European Commission (EC) published its roadmap (Roadmap) for the implementation of Regulation (EU) 2017745 on Medical

CAMD released roadmap concerning the priorities for the implementation of the MDR and IVDR
  • Hogan Lovells
  • European Union
  • November 23 2017

The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”

Higher Risk Medical Devices - New Rules
  • McCann FitzGerald
  • European Union
  • September 8 2017

EU Regulations passed on 5 April 2017 will strengthen the regulation of medical devices, in particular higher risk medical devices (including

Life Sciences Newsletter No. 4
  • Gómez-Acebo & Pombo Abogados
  • European Union
  • July 13 2017

At present, medical devices are regulated in the EU by three directives dating back to the 1990s: (a) Council Directive of 20 June 1990 on the

Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
  • Jones Day
  • United Kingdom, European Union
  • June 4 2017

The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United