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Results:1-10 of 53

Brexit: “placing on the EU market” of products inc. medical devices
  • Hogan Lovells
  • United Kingdom, European Union
  • February 11 2019

The Q&A document provides that the following products will be considered to have been placed on the EU-27 market on the withdrawal date: Products


New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices
  • Hogan Lovells
  • United Kingdom, European Union
  • February 6 2019

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


Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products
  • Hogan Lovells
  • United Kingdom, European Union
  • February 1 2019

The Q&A document provides that the following products will be considered to have been placed on the EU-27 market on the withdrawal date: Products


New Belgian legislation on the distribution of medical devices
  • Hogan Lovells
  • Belgium
  • January 28 2019

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical


Regulatory Insights for Life Sciences and Health Care Investments: Regulatory changes in Europe
  • Hogan Lovells
  • European Union
  • December 7 2018

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure


The European Commission publishes nine new guidance documents in relation to the MDR and IVDR
  • Hogan Lovells
  • European Union
  • November 23 2018

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in


The new Belgian Biobank legislation will apply on 1 November 2018: are you ready?
  • Hogan Lovells
  • Belgium
  • October 23 2018

The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19


New “rolling plan” and new guidance documents in relation to the MDR and IVDR
  • Hogan Lovells
  • European Union
  • October 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


MDR and IVDR: the European Commission published some guidance documents
  • Hogan Lovells
  • European Union
  • August 13 2018

In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the


Brexit, medical devices and transfer of notified bodies. What will be the procedure?
  • Hogan Lovells
  • United Kingdom, European Union
  • August 7 2018

In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common