How to set-up your Post-Market Surveillance and Vigilance system for IVDs

May 6, 2022

Do you know how to set-up the post-Market surveillance (PMS) and Vigilance system in order to comply with the IVDR?

After the challenges brought by the transition to MDR for Medical Devices, we are happy to present you with this practical session as a webinar to provide you with tips and best practices to make sure that the transition to IVDR runs as smooth as possible while complying with the new regulation.

Laura Eder, Drug Safety Manager at Asphalion, will deliver this webinar.

🔗 Registrations are open. You can register here:

https://bit.ly/3kHO45J

📅26^th may 2022 🕑2:00- 3:00 p.m. CEST

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EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices.

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Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

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The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

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How to set-up your Post-Market Surveillance and Vigilance system for IVDs

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