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Implications of the one-year postponement of the application of the Medical Devices Regulation (MDR)

Implications of the one-year postponement of the application of the Medical Devices Regulation (MDR)
Published on: 12 May 2020
Published by: LexisPSL
  • Implications of the one-year postponement of the application of the Medical Devices Regulation (MDR)
  • Since the MDR came into force in May 2017, many manufacturers and others have been preparing to achieve compliance. Why has the application of the MDR been postponed and which stakeholders benefit the most from this delay?
  • Which provisions of the MDR have been amended?
  • What is the practical impact of these amendments to the transitional regime?
  • What are the wider implications of these amendments to the medical devices regime as set out in the MDR?
  • What should be done by the Commission, the MDCG and stakeholders before 26 May 2021 for the MDR regime to be properly implemented?
  • The medical devices industry called for the postponed application of the In Vitro Diagnostic Regulation (IVDR) too. What are the likely consequences for businesses of the IVDR coming into application in May 2022?
  • Considering the current Brexit transition period and the ongoing UK-EU negotiations on the future relationship, what are the possible implications of the MDR’s postponed application for the UK medical devices regime?

Article summary

Life Sciences analysis: Regulation (EU) 2020/561 amends Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) by postponing its application to 26 May 2021. Elisabethann Wright and Fabien Roy, partners at Hogan Lovells International LLP, undertake an analysis of the broad implications of this postponement. or take a trial to read the full analysis.

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