IVDR Celebration Week Session 2
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
Session 2 – Tuesday 26th April 2022 @ 11:00 AM BST - IVDR and the Clinical Requirements for IVD Manufacturers in Europe
Diagnostic devices have robust clinical requirements. Many diagnostic companies know the product's intended use but fail to justify it clinically. Avoid such pitfalls by developing a clinical strategy. Our Resource Partner - Liz Tully – Managing Partner Xenon Health Solutions, will take you for a 'Behind the Scenes Tour' on getting the right clinical strategy. That's not it! Diagnostic companies require a legal representative for running clinical trials. Greer Deal – Director – Global Regulatory Services will clear up any misconceptions around PRRC and Legal Rep for Clinical Trials.
Tune in on Tuesday 26th April 2022 at 11:00 AM BST
Have questions around this topic?
Send us an email: mdd@mddltd.com
We are your regulatory risk partners for Medical Devices, Diagnostics and Digital Health!
Link to Broadcasts
Resource Partners
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