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.
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, Commission’ s Proposal
- UK & Switzerland: What is expected?