RSQ-014 - Challenges in accessibility to CE marked medical devices within the European Union

• At: Copenhagen (Denmark) (2025)
• Type: Poster
• Poster code: RSQ-014
• By: CATANIA, Julia (University Of Malta, Malta)
• Co-author(s): Ms Julia Catania (University Of Malta, Msida, Malta)
  Dr Louise Grech (Medical Devices, Pharmaceutical Collaboration and Entrepreneurship, Malta Medicines Authority, San Gwann, Malta)
  Dr Nicolette Sammut Bartolo (University Of Malta, Msida, Malta)
  Professor Anthony Serracino Inglott (University Of Malta, Msida, Malta)
  
• Abstract:

  Introduction: The European Union (EU) has introduced the 2017/745 Medical Device Regulation (MDR), and the 2017/746 In Vitro Diagnostic Regulation (IVDR) to address the safety, quality and efficacy of medical devices available in the EU market. These regulations introduced challenges to pharmacists and stakeholders, such as medical device..

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