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  • Regulatory NewsRegulatory News

    MDR Guidance Addresses Transitional Provisions

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued in accordance with the previous device directives will remain valid until 27 May 2024. The MDCG notes that Article 120(3) of MDR establishes that the notified body that issued a device certificate continues to be responsible for the appropriate device surveillance ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Report Calls to Minimize Amount of Data Generated by Sponsors (28 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Report Calls on Regulators, HTAs to Minimize Sponsor Data-Generation Requirements The European Parliament’s policy department has published a report recommending regulators and health technology assessment (HTA) bodies take steps to minimize the amount of data demanded of drug developers. Members of the Directorate for Economic and Scientific Policies made the proposal in...
  • RAPS' LatestRAPS' Latest

    Embracing Change in EU Medical Device Regulation: The Notified Body Perspective

    The RAPS San Francisco Bay Area Chapter kicked off 2014 with a 7 March conference focused on the proposed EU medical device regulations. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. The message was clear-change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. A BSI Healthcare medical device expert team p...