février 11, 2021 - février 12, 2021
Date: February 11th & 12th
Time: 9am-5pm CET
The date of application is drawing closer and there are no indications that there will be a blanket extension to the IVDR. The IVD sector faces significant efforts to plan for and complete before May 2022 to comply with the new IVDR. The transition from complying with the current IVD Directive to meeting the new IVDR requirements involves significant preparation and report/data generation to be ready for additional notified body review and scrutiny. All stakeholders now have some experience reviewing submissions and there are lessons to be learned to improve your submissions and therefore speed to market.
During this two-day workshop, IVD regulatory experts from various stakeholder groups will share some of this practical experience and top tips with delegates. This is an invaluable opportunity to share experience and gain experience from discussions with experts and peers as we all prepare to comply fully with the new regulations. The workshop be particularly valuable to all regulatory professionals responsible for achieving IVDR compliance for legacy CE IVDD products, but also new IVDs and CDx intended for the European market.
This workshop sold out very quickly in 2020, so early registration advised.