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Hybrid Event, 20 - 24 June 2022
In-Person: Dublin, IrelandDigital Experience: One track will be live-streamed
each day in GMT time zone, with on-demand recording access for all other tracks
made available on the afternoon of the following day. Learn more on the Digital
Experience page.
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Hybrid Event, 20 - 24 June 2022
In-Person: Dublin, IrelandDigital Experience: One track will be live-streamed
each day in GMT time zone, with on-demand recording access for all other tracks
made available on the afternoon of the following day. Learn more on the Digital
Experience page.


Hybrid Event, 20 - 24 June 2022
In-Person: Dublin, Ireland,
Digital Experience: One track will be live-streamed each day in GMT time zone,
with on-demand recording access for all other tracks made available on the
afternoon of the following day. Learn more on the Digital Experience page.


EU IVDR. 26 MAY 2022. ARE YOU READY?


FAST-TRACK YOUR IMPLEMENTATION STRATEGY WITH NOTIFIED BODY FEEDBACK, INDUSTRY
CASE STUDIES AND INSIGHTS FROM LEADING IVD COMPANIES

EU IVD Regulatory Timelines. Reference Labs. Notified Body Capacity. Clinical
Evaluations. Post Market Surveillance. And More!
See the EU IVDR agenda



ACCELERATE YOUR PATH TO EU IVDR COMPLIANCE WITH EXPERT GUIDANCE




EXPLORE THE LATEST REGULATORY UPDATES WITH NOTIFIED BODIES AND INDUSTRY

 * How will Notified Bodies address capacity concerns? Prioritisation, virtual
   audits & challenges
 * Explore successful approaches to IVDR implementation based on device class
 * Enhance the IVDR implementation process with feedback on common mistakes in
   documentation, tips on improving applications and best practice for working
   with NBs with TÜV SÜD


FIRST EXPERIENCES WITH THE NEW REGULATION

 * IVDR transitional provisions: Regulatory strategy to address extended scope
   and timelines
 * IVDR compliance: Addressing clinical evidence, challenges encountered and key
   learnings
 * Post Market Surveillance: Gain insights on setting up a robust system, from
   technical document requirements to data collection and PSPR requirements


HELPING YOU REACH IVDR SUCCESS

 * Obtaining a CE mark under the IVDR: Hear a case study from leading industry
   figures
 * Hear a case study on Economic Operators from Ortho Clinical Diagnostics
   addressing labeling requirements and importing/exporting CE-Marked products
 * Assess the unique requirements for companion diagnostics, exploring the
   interface between the EU clinical trial regulation (CTR) and IVDR

See the EU IVDR agenda


EU IVDR COMPLIANCE: TIME CRITICAL INSIGHTS FROM AN EXPERT SPEAKER LINE-UP

Gain leading implementation and compliance advice from WHO, Notified Bodies &
IVD Manufacturers


CLAUDIA DOLLINS

HEAD GLOBAL REGULATORY SCIENCE, PRECISION MEDICINE AND COMPANION DIAGNOSTICS

BMS


MARTA CARNIELLI

IVD TECHNICAL OFFICER

TÜV SÜD PRODUCT SERVICE GMBH


SINEM YAMAN

VICE PRESIDENT, REGULATORY AFFAIRS & QUALITY ASSURANCE EMEA

SYSMEX EUROPE


WAÏSS FAISSAL

REGULATORY AND COMPLIANCE MANAGER, NORTHERN EUROPE & DACH

ORTHO CLINICAL DIAGNOSTICS

Meet the EU IVDR speakers


ELSEWHERE AT MEDTECH SUMMIT




#MedTech
 * MedTechIC
 * MedTech: Regulation & Strategy
 * MedTech Summit
 * Medical Device Regulatory Affairs

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