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https://www.um.edu.mt/library/oar/handle/123456789/103992| Title: | Challenges to medical device accessibility following the New European Union regulations governing notified bodies for medical devices |
| Authors: | Vella, Mariah Serracino-Inglott, Anthony |
| Keywords: | Medical instruments and apparatus European Union Medical care -- Malta |
| Issue Date: | 2022 |
| Publisher: | International Pharmaceutical Federation |
| Citation: | Vella, M., & Serracino-Inglott, A. (2022). Challenges to medical device accessibility following the New European Union regulations governing notified bodies for medical devices. 80th FIP World Congress of Pharmacy and Pharmaceutical Sciences, Seville. |
| Abstract: | The EU medical device (MD) regulatory structure has changed from Directives to Regulations to ascertain safety, quality, and efficacy of MDs in the EU market. The EU Regulations are complex and have increased safety partly by adapting stringent requirements for Notified Bodies (NBs). |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/103992 |
| Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Challenges_to_medical_device_accessibility_following_the_New_European_Union_regulations_governing_notified_bodies_for_medical_devices_2022.pdf | 198.76 kB | Adobe PDF | View/Open |
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