EU IVDR Implementation Strategies
A virtual conference
February 24 – 26, 2021
The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, reporting, data management, and a reassessment of legacy portfolios. Even the largest and best-prepared companies struggle with implementation, which involves strategic thinking and buy-in at the highest levels.
Anyone can read the regulation: the challenge is in how to apply it to a company’s particular structure and product line. This interactive workshop convenes experts from major diagnostics companies, notified bodies, and consulting firms to share strategies, procedures, experiences, and challenges.
Who should attend:
· RA/QA
· Clinical affairs
· Risk management
· Supply chain
· Compliance / auditing / legal
· Labeling
· Software / IT
· International
· Postmarket surveillance
What you will learn:
· Provisions and timeline of EU IVDR
· Reclassification and up-classification
· Conformity assessments
· The changing role of notified bodies
· Risk management under EU IVDR
· Quality processes and documentation
· Clinical performance evaluation
· Postmarket surveillance
· Postmarket follow-up studies and reports
· Supply chain and economic operators
· Labeling, UDI, and public information
· Remediation of legacy diagnostics and portfolio assessment
· Companion diagnostics
· Software and privacy rules
· Organization, strategy, budgeting, and planning
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FREQUENTLY ASKED QUESTIONS
What are the registration prices:
Medical Technology Organization:
- Early bird registration is $695 - Available until Jan. 1, 2021
- Regular Registration is $895 - Available between Jan. 2, 2021 - Feb. 5, 2021
- Late Registration is $1195 - After Feb. 5, 2021
Group Registrations:
If you register a group of more than 2 registrations at the same time, each registration after the 1st receives a 50% discount. Remember, in order to receive this discount, registrations MUST BE MADE AT THE SAME TIME. There will be no retroactive refunds of registration fees.
How do I log in to the event?
- You will receive an email with a link to GoToWebinar with instructions how to log into the live event. Please note that this will be a live event.
Can I ask questions of the speakers?
- Yes! You will be able to type your questions into a chat dialog box and the moderator will read it out loud to the speakers.
What happens if I miss the event:
- There are no refunds or cancellations within 7 business days of the starting date of the event.
Cancellation and Refund Policy:
- All cancellations must be made via email. Should you not be able to attend the virtual event, you may have someone else from your organization take your place or use your registration fee as credit towards a future MedTech Intelligence event. If these options are not possible, you can receive a refund of the registration fee less a 20% processing fee up until 7 business days prior to the virtual event. There are no refunds for cancellations within the 7 day period prior to the virtual event or for "no-shows" to the virtual event.