This one-day workshop goes into the details of how to transition your company, its CE marked devices and its supply chain, to the new requirements under the new EU medical devices and IVD regulations. These regulations have already entered into force in May this year and provide for a relatively short transition period with no grandfathering for devices or diagnostics that are already on the market. This means that you will have to plan to revisit the technical documentation, clinical evidence, risk management, supply chain organization and other CE mark relevant aspects of your devices and diagnostics and assess the gaps to achieve compliance under the new regulations. Where devices or diagnostics have to be certified by a notified body, this will have to happen again against the standards that are not yet completely articulated under the implementation process of the new regulations.
The workshop will address the major changes brought about by the regulations, how these affect your devices and in vitro diagnostics, how to set up a transition plan that includes a gap assessment that addresses all the relevant points. As part of the workshop relevant templates (e.g. for a transition plan and a gap assessment) will be provided. The workshop is an excellent opportunity to learn and understand how to operationalize and execute transition to the new EU regulations from both a regulatory and legal perspective.
Agenda topics include:
- Medical devices and IVDs specifics under MDR and IVDR
- Setting up your overall transition plan and discussion of timelines
- How to set up and perform a gap assessment?
- Implementing your transition plan and their party dependencies
The workshop will be presented by Erik Vollebregt. Erik is founding partner of the EU life sciences boutique law firm Axon Lawyers and a specialist in EU medical devices regulation.
701 Pennsylvania Ave., N.W., Ste. 800
Washington, DC 20004
AdvaMed Member Registration: $495.00
Accel Member Registration: $395.00
Government and Non-Profit Registration: $395.00
Non-Member Registration: $595.00
Cancellation and Refund Policy
All cancellations must be received via email to AdvaMedEvents@AdvaMed.org (link sends e-mail). Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact us at AdvaMedEvents@AdvaMed.org (link sends e-mail) with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.