• RoundupsRoundups

    Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID

    Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it emerge from the “twin challenges of Brexit and COVID-19” and deliver better outcomes for people and animals.   The five goals are titled health system partnerships, progressive regulation, communication and engagement, enabling innovation and great people, great processes. By engaging in activities that further those goals...
  • RoundupsRoundups

    Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

    Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.   Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU ...
  • Regulatory NewsRegulatory News

    Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA

    Switzerland’s medical technology lobbying group issued recommendations to manufacturers Thursday to prepare for different possible regulatory scenarios because of uncertainty with the Institutional Agreement between the EU and Switzerland (InstA). Stalling the InstA “directly affects the medical technology sector,” said Swiss Medtech. The group noted challenges with not knowing whether support for the InstA will be voiced and whether Switzerland and the EU’s Mutual Reco...
  • Regulatory NewsRegulatory News

    Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

    Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation. France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee doe...
  • RAPS' LatestRAPS' Latest

    RAPS Switzerland Chapter Becomes Official Nonprofit Association Under Swiss Law

    RAPS announced today that its RAPS Switzerland Chapter has completed the official registration process as a not-for-profit association under Swiss law. The announcement was made during RAPS’ 2017 Regulatory Convergence conference taking place at the Gaylord National Resort and Convention Center at National Harbor on the Washington, DC, waterfront 9–12 September. While the group has been an official RAPS chapter since 2011, this new status gives it additional l...