Date: 4 June 2018
Duration: 1 Day
Location: Amsterdam Area
Subscription: On request
The IVD Directive came into force in 1998. The world was much different then. The IVD’s regulatory framework is based on lists of products, which makes it difficult to cope with new products that do not fit into the lists.
All new innovations make a very good case for an IVD Regulation that serves the patient well today and that can adapt to changes in knowledge and technology going forward.
The new structure and revised scope of the IVDR
New classification rules
How to determine the conformity route
Technical documentation changes
Post Market surveillance
Supply chain requirements