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IVDR Celebration Week Session 5


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 5 – Thursday 28th April 2022 @ 11:00 AM BST - What is a clinical performance study, and why do you need it?


The end goal of a diagnostic device is to diagnose and test the symptoms of the end-user, but what comes before that is all about the production process and various testing requirements.

One critical requirement is to fulfil a Clinical Performance Study. Interact LIVE with Nicola Wall – CEO – Afortiori Development, who will appraise the facts related to the Clinical Performance Study. Also, Greer Deal – Director - Global Regulatory Services (GRS) – shall complement this session with essential information related to a company’s Quality Management System (QMS) and how this supports clinical activities.


See you on Thursday 28th April 2022 @ 11:00 AM BST


Have any questions?

Drop us an email:

Regulation - Our Passion, Your Innovation.


What is a clinical performance study, and why do you need it

Link to Broadcasts 






Resource Partners 

Health Innovation Hub Ireland 

Medilink Midlands

Xenon Health Solutions 

Galway Chamber 

GS1 Ireland 

Afortiori Development

Embassy of India - Dublin, Ireland 


IVDR ReadyIVDR Clinical Requirements IVDR Quality Management Systems IVD Regulations consultancy




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