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Complying with the EU Market Regulations can be a daunting task to undertake on your own. Make sure you get all the information you need. 

We bring our experience and knowledge in the medical devices and in-vitro diagnostics industries, so don't miss the webinar!

33 YEARS OF QUALITY

SERVICE IN REGULATORY AFFAIRS

Obelis brings together top speakers from the IVDR industry to guide you through the In-Vitro Diagnostics regulatory landscape for the EU, UK and Switzerland. 

This Roundtable provides the opportunity for an exchange between relevant stakeholders such as notified bodies, supervisory authorities and business associations to minimise uncertainty in interpreting the new IVDR regulations.

Don’t miss this unique opportunity to learn suggested strategies and best practices that lead to successful IVDR transition and outcomes.

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Key insights and information will be provided on:

  •  Notified Body state of play 
  •  Regulatory infrastructure (guidance docs, EUDAMED)
  •  EUDAMED Challenges (actor & device) 
  •  Approach of the NB for Covid19
  •  IVDR transition - Measures, Regulation EU 2022/112
  •  UK & Switzerland: What is expected?

IVDR IS COMING: 

HOW TO GET READY!

Business Development Manager | Obelis Group

Karima Benkhallouq

IVD Technical Officer | TÃœV SÃœD

Marta Carnielli

Chief Compliance Officer | Obelis Group

Sandra Ferretti

Moderator

Topics

  • EUDAMED Challenges (actor & device)
  • UK & Switzerland: What is expected?

Topics

  • Approach of the NB for Covid19
  • Notified Body state of play
  • Regulatory infrastructure (guidance docs, EUDAMED)
  • IVDR transition (Measures, Commission' s Proposal)