Date: 19 March 2024
Time: 17:00 - 18:00 CEST | 4 PM - 5 PM GMT | 11 AM - 12 PM EST | 8 AM - 9 AM PST
Location: Virtual
Language: English
Introduction
Join this free webinar this free webinar organized by SelectScience with Qserve IVD expert Sue Spencer, Dr Julien Senac (TÜV SÜD) and Erik Vollebregt (Axon Lawyers) as they explain what the extension to the IVDR means for manufacturers.
Despite considerable progress in transitioning to the IVD rules introduced in 2017, and the additional time given to implement them, progress in the sector remains slow. Last year, the European Commission took steps to ensure the availability of medical devices, and now in 2024 further steps are being proposed to ensure the availability of certain IVDs, accelerating the sector’s progress towards the transition. This webinar brings together experts from notified bodies, industry, and the legal sector to deliver a comprehensive update on what this latest extension to the IVDR means for you.
Learning Objectives:
Extension to the IVDR, what does it mean for you?
- What is the proposal?
- What is the extension?
- Proposed changes to EUDAMED and how they relate to IVDs.
- Impact on the conformity assessment process
- How should I use the extra time?
- Opportunities and threats
- Things to consider about using the extra time?
- Difficult conversations with senior managers
- The bigger picture
- The EU is reviewing the way devices are regulated, what is the process?
- What could be on the horizon?
- Lessons learnt from the MD extension.
- Q+A with the experts
Who should attend:
- IVD Decision-makers/market strategy
- R&D/Clinical Performance Study staff
- Quality and regulatory staff
- Operational staff
- EU Authorised Representatives and importers of IVDs
Registration:
You can register via the SelectScience registration link.
About SelectScience:
Accelerating science by connecting scientific communities with trusted solutions.
SelectScience informs scientists about the best products and technology through the power of peer-to-peer recommendation.
They partner with product, technology and service suppliers to engage with scientists and regulatory experts ’ feedback, and to promote those products and brands.
External presenters:
Dr Julien Senac - Global Director, IVD Focus Team, TÜV SÜD
Erik Vollebregt - Partner, Axon Lawyers
Qserve presenter: