In Vitro Diagnostics product have been recently subject to changes by regulators world-wide. No longer do the regulators believe that their current system, which largely rely on manufacturer’s doing the right thing, is sufficient for the growing number of IVD products used during patient treatment. It is also not reasonable to believe that following the Medical Device frameworks for these regulatory agencies, as the risks and technical documentation used to substantiate their safety and effectiveness are very different from its MD counterparts. So, special considerations must be made for the requirements of IVDs with regulatory agencies worldwide, with special attention to recent developments.
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.
Principal Consultant / Consulting Operations Manager
TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices.
TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA. He has provided due diligence activities for company acquisitions regarding the target’s business viability, quality system status and regulatory position. TJ’s expertise also supports businesses to create, revise and execute quality systems that are efficient and understood by all employees to provide compliance in a consistent and concise manner.