Economic Operators under EU MDR
A Virtual Event
September 02, 2020

One of the most challenging aspects of EU MDR are the economic operator requirements.  Identifying internal or external economic operators, understanding roles and responsibilities, guaranteeing the appropriate degree of independent oversight, and establishing the appropriate quality and other agreements and procedures are complex and confusing.


Join MedTech Intelligence for a roundtable discussion in which experts from industry, notified bodies, and consulting firms have identified the challenges and established procedures for managing them. Add to the discussion by submitting your own questions in advance or during the webinar.


Topics of Discussion:


Why the EU MDR emphasis on economic operators?

Who are the economic operators and what are their respective responsibilities?

The challenges of internal economic operators

When distributors assume a manufacturer’s role

Verification of Regulatory Compliance

Traceability, UDI, and Reporting Requirements

What can go wrong

Contractual Arrangements with Suppliers and Economic Operators


Who should attend:

·      Regulatory/Quality

·      Supply chain

·      Legal

·      Auditors



Visit www.medtechintelligence.com

Agenda
Wednesday, September 2
12:00 PM
12:00 PM
12:00 PM - 12:05 PM
12:00 PM - 12:05 PM
12:05 PM - 1:20 PM
12:05 PM - 1:20 PM
1:20 PM - 1:30 PM
1:20 PM - 1:30 PM
1:30 PM
1:30 PM
Speakers
Global Director, Sales & Strategic Marketing - Medical & Health Services
TÜV SÜD
CEO & Co-Owner
Qunique GmbH
Director, Corporate Regulatory Affairs
Edwards Lifesciences
Director Regulatory Affairs
Regulatory & Quality Solutions
Project Manager
Boston Scientific
EU Medical Device Regulation Project Champion
W. L. Gore & Associates
Management Consultant
PA Consulting

FREQUENTLY ASKED QUESTIONS

What are the registration prices:

Medical Technology Organization:

  • Early bird registration is $95 - Available until Aug. 3, 2020
  • Regular Registration is $125 - Available between Aug. 4- Aug. 24, 2020
  • Late Registration is $150 - After Aug. 24, 2020

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 by Sept. 1, 2020.  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 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.