This webinar presents a summary of the common terminology when identifying IVDs, including in-house, stand-alone, point-of-care, self-testing and Companion Diagnostic IVDs. For each of these different IVDs, there is generally different classification for all regulatory agencies. This webinar also describes how IVDs some unique standards that should be complied to in the development of the product, from performance evaluation to labelling. IVDs also will have unique documents that are incorporated into their Technical File; these are described in detail in this webinar.
This webinar then addresses the changes that have occurred in three primary jurisdictions, Australia, the United States, and European Union. Australia has no new changes for their regulation of IVDs, as those changes have already been adopted; these Australian requirements are in-line with the new European changes under IVDR. The United States did not change their guidance around IVDs drastically, particularly in classification or regulatory pathways, but provided additional clarifications around CLIA requirements, as well as dual 510(k) and CLIA applications. Europe is undergoing the most drastic changes to IVD products, moving from the IVDD to the IVDR, creating new definitions, classifications, conformity routes, sampling requirements, clinical evidence requirements and post-market activity requirements. With the classification changes in the European Union, manufacturers will see a large difference in the number of applications that they must lodge with the Notified Bodies. Previously 20% of IVD products required Notified Body review under the IVDD, but now 80-90% will require that review under IVDR. Clinical evidence for IVDs will now require documentation of scientific validity, analytical performance, and clinical performance. Europe has also changed the requirements of the different economic operators so that all organizations involved with the product will be responsible for that product.oduction activities. Finally, best practices are covered which include a look at how risk management processes fit into the product development design control processes and the key activities required with helpful hints.
Key learning objectives:
- Understanding of the definitions for types of IVDs and applicable to IVD products worldwide.
- Australia changes for IVDs have already been adopted, in-line with the new European changes under IVDR; if manufacturers are having to make a lot of changes for Europe, you will be aligned with the Australian approach.
- The United States did not change their guidances around IVDs drastically but provided additional clarifications around dual 510(k) and CLIA applications.
- Europe includes the most drastic changes to IVD products, moving from the IVDD to the IVDR, creating new classifications, new rules and new guidances; whereas 20% of IVD products required Notified Body review under the IVDD, 80-90% will require that review under IVDR.
