Getting Ready For The IVDR

The implementation of the In Vitro Diagnostic Regulation (IVDR) marks a significant paradigm shift for manufacturers distributing products in Europe. Under the IVDR, companies now face a substantial change, as up to 90% of products require review by a notified body before they can be distributed in Europe. This stands in stark contrast to the previous landscape governed by the In Vitro Diagnostic Directive (IVDD), where roughly 80% of products were self-declared to the directive. To gain deeper insights into the implications and intricacies of this regulatory transformation, tune in to our latest PharmaLex podcast featuring expert analysis from Terrance Thiel.

Speaker Bio: Terrance T.J. Thiel is the Senior Director and Principal Consultant of Medical Devices / IVD. He has worked in quality and regulatory affairs in the Australian, U.S., and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, Thiel has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and worldwide product launches.

Thiel has prepared, submitted, and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables, and Software as Medical Devices (SaMD) – and in vitro diagnostics including point-of-care, self-testing, and laboratory devices. Thiel 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.

Thiel's expertise also supports businesses to create, revise, and execute quality systems that are efficient and understood by all employees to provide compliance consistently and concisely.