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 26^th May 2022.

Session 5 – Thursday 28^th 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 28^th April 2022 @ 11:00 AM BST

Have any questions?

Drop us an email: mdd@mddltd.com

Regulation - Our Passion, Your Innovation.

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