IVDR Celebration Week
Med-Di-Dia and Global Regulatory Services are organising a series of weeklong fireside chats to celebrate the incoming IVD Regulations in the European Union.
This is a big buzz in the MedTech and regulatory space. For the first time, In-Vitro Diagnostic Medical Devices are coming under a strict regime and vigilance dedicated to this sector. IVDR (In-Vitro Diagnostic Regulations) will be succeeding the MDD (Medical Device Directives) and will be enforceable from 26th May 2022
- Opening Ceremony - Monday 25th April 2022 @ 11:00 AM
Session 1 – Monday 25th April 2022 @ 2:00 PM BST - Overview of IVDR
Session 2 – Tuesday 26th April 2022 @ 11:00 AM BST - IVDR and the Clinical Requirements for IVD Manufacturers in Europe
Session 3 – Wednesday 27th April 2022 @ 11:00 AM BST - IVD Medical Device - Understanding SaMD and Cyber Security Requirements
Session 4 – Wednesday 27th April 2022 @ 2:00 PM BST - IVD Medical Device - the need for UDI and Barcodes
Session 5 – Thursday 28th April 2022 @ 11:00 AM BST - What is a clinical performance study, and why do you need it?
Session 6 - Thursday 28th April 2022 @ 02:00 PM BST - Where to Start in order to launch an IVD Medical Device onto the EU Market
The event will be opened by the Indian Ambassador to Ireland, H.E. Akhilesh Mishra and Galway Chamber President – Aengus Burns.
Embassy of India - Dublin, Ireland
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