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 26^th May 2022

Session Detials 

• Opening Ceremony - Monday 25th April 2022 @ 11:00 AM 

• Session 1 – Monday 25^th April 2022 @ 2:00 PM BST - Overview of IVDR

• Session 2 – Tuesday 26^th April 2022 @ 11:00 AM BST - IVDR and the Clinical Requirements for IVD Manufacturers in Europe

• Session 3 – Wednesday 27^th April 2022 @ 11:00 AM BST - IVD Medical Device - Understanding SaMD and Cyber Security Requirements

• Session 4 – Wednesday 27^th April 2022 @ 2:00 PM BST - IVD Medical Device - the need for UDI and Barcodes

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

• Session 6 - Thursday 28^th April 2022 @ 02:00 PM BST - Where to Start in order to launch an IVD Medical Device onto the EU Market

• Closing Ceremony - Friday 29th April 2022 @ 02:00 PM 

The event will be opened by the Indian Ambassador to Ireland, H.E. Akhilesh Mishra and Galway Chamber President – Aengus Burns.

Resource Partners 

Health Innovation Hub Ireland 

Medilink Midlands

Xenon Health Solutions 

Galway Chamber 

GS1 Ireland 

Afortiori Development

Embassy of India - Dublin, Ireland 

Register for the session and Updates by Clicking here

For more queries, please write to mdd@mddltd.com

#IVDRReady

#RegulatoryCompliance #EUAR #PRRC #USFDA #MDR #IVDR #MedicalDevices #Diagnostics #DigitalHealth #EUAuthorisedRepresentative #ClinicalTrials #Innovation #HealthTech #ClinicalEvaluation #UDI #SaMD 
#PersonResponsibleForRegulatoryCompliance #CyberSecurity #RegulatoryAffairs #MDCG