During this session, the PharmaLex Medtech Expert, T.J. Thiel, will revisit the Medical Devices Directive (MDD, 93/42/EEC) and In Vitro Diagnostic Directive (IVDD, 98/79/EC) and their transitions to the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746), respectively. This webinar will compare the Directives and the new Regulations, highlighting the reason for change, but also the specific changes themselves. We will also focus on implementation deadlines, and how to implement new or enhanced requirements such as Clinical Evidence Reports (CERs), Post Marketing Surveillance (PMCF, PMPF, SSCP, PSUR, etc.), UDI, and EUDAMED.
Although the MDR transition has recently passed, there are still organisations trying to remediate their products to remain on the market in Europe. For those with valid MDD/AIMDD certificate products who are in the process of transitioning to MDR by 2024 (when all MDD/AIMDD will become void), we will share insights and key actions to take for an effective transition based on experience from the first cohort of MDR certification companies. For other organisations that are currently applying and receiving MDR certificates, we will discuss how to maintain compliance, especially with the increased requirements around clinical evidence and post-market activities.
For all companies navigating IVDR towards the 2022 deadline, we will discuss readiness assessments and key enhanced requirements. We will discuss the differences in the classification of these products and the conformity assessment pathways organisations will face with the Notified Bodies, maybe for the first time. This webinar will also include some specific examples, and explore the regulations effects on In-House IVDs/Laboratory Developed Tests (LDTs) and key considerations for Companion Diagnostics.
With this webinar, we hope to inform organisations currently struggling with the burden of the transition and provide some best practices, points-of-emphasis and key requirements to ease the burden face in the most efficient manner possible.
Senior Director, Medical Devices/IVD
T.J. 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.