Please use this identifier to cite or link to this item:
https://www.um.edu.mt/library/oar/handle/123456789/139544| Title: | Challenges in accessibility to CE marked medical devices within the European Union |
| Authors: | Catania, Julia Grech, Louise Sammut Bartolo, Nicolette Serracino-Inglott, Anthony |
| Keywords: | Medical instruments and apparatus -- Safety regulations -- European Union countries Pharmacy -- Study and teaching (Higher) -- European Union countries Medical instruments and apparatus -- Standards -- European Union countries Medical instruments and apparatus -- Testing Drugs -- Law and legislation -- European Union countries |
| Issue Date: | 2025 |
| Publisher: | International Pharmaceutical Federation, Federation Internationale Pharmaceutique |
| Citation: | Catania, J., Grech, L., Sammut Bartolo, N., & Serracino-Inglott, A. (2025). Challenges in accessibility to CE marked medical devices within the European Union. Pharmacy Education, 25(4), 9. |
| Abstract: | Introduction: The European Union (EU) has introduced the 2017/745 Medical Devices Regulation (MDR), and the 2017/746 In Vitro Diagnostic
Medical Devices Regulation (IVDR). These regulations introduced challenges to pharmacists and stakeholders, such as medical
device manufacturers and importers. The need for competence building1 in medical devices regulatory compliance through
pharmacy education was identified. Aims: To identify challenges faced by stakeholders, brought about by the implementation of the current EU Regulations, 2017/475 MDR and 2017/746 IVDR. |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/139544 |
| Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Challenges in accessibility to CE marked medical devices within the European Union 2025[poster].pdf | 178.92 kB | Adobe PDF | View/Open | |
| Challenges_in_accessibility_to_CE_marked_medical_devices_within_the_European_Union(conf_abstract)(2025).pdf | 343.67 kB | Adobe PDF | View/Open |
Items in OAR@UM are protected by copyright, with all rights reserved, unless otherwise indicated.