IVDR Rollout 2023: Innovation vs Legacy: How to define a Clinical Evidence Strategy for an established analyte/marker or technology versus a novel product.

THIS WORKSHOP IS SOLD OUT.

Description: The European In-Vitro Diagnostics Regulation (IVDR, 2017/746) is heavily focused on clinical evidence for in vitro diagnostic medical devices (IVDs) in Europe and introduces new requirements for performance evaluation including scientific validity, clinical performance and state of the art, and recognizes new device types such as companion diagnostics.
This workshop is provided by experts with diverse backgounds in notified body, IVD consulting and device manufacture, and aims to provide participants with strategies to establish state of the art , scientific validity and clinical performance for various IVDs, regardless of class, type or length of time on market. The workshop will cover the elements required for a robust clinical evidence strategy for legacy and novel devices, with a particular focus on methods for establishing clinical evidence for challenging new or innovative devices, including companion diagnostics. Furthermore, the workshp will discuss the importance to include a PMPF concept in the clinical strategy considering legacy versus novel devices, e.g. which triggers deemed to be applicable to initate PMPF activities.

Session 1: Clinical Evidence - Regulatory Overview
• New clinical evidence requirements for IVDs
• Performance Evaluation process and documentation requirements
• Clinical Evidence: How does this differ between legacy and novel devices, and common problems/challenges in preparation for IVDR
• PMPF: Understanding the concept, implications for legacy versus novel devices
• How to define (and maintain) state of the art

Session 2: Clinical Evidenence – Which strategy for legacy versus novel devices
• Scientific Validity: Which sources can be applied to demonstrate sufficient evidence for legacy IVDs versus novel products
o Overview of Scientific Validity Sources applicable under the IVDR
o Scientific Literature Review Best Practices for legacy IVDs, including strategies for controls, calibrators, instruments and/or software.
o Design of proof of concept studies, e.g. for novel devices
• Clinical Performance: Which sources can be applied to demonstrate sufficient evidence for legacy IVDs versus novel products
o Overview of Clinical Performance Sources applicable under the IVDR
o How to derive clinical performance data from literature for legacy IVDs
o Design of Clinical Performance studies, what to consider
o Other sources of clinical performance data – what does that mean?
• PMPF – understanding the PMPF triggers and significance in the respective clinical evidence stratgey.

Session 3: Companion Diagnostics(CDx) under the IVDR
• Regulatory overview
o Definition of CDx and a complementary diagnostics including EU versus USA
o Overview of the CDx Conformity assessment route, e.g. consultation & communication of/with the EMA
o Lessons Learnt from the first issued CDx certificate
• Discussion on different CDx categories: co-developed, follow-on, legacy. Understand the data required by notified bodies and respective drug agencies and communicate accordingly with product development and regulatory affairs teams
• LDTs (in-house exemptions) applicable for CDx? Understand the in-house concept in the precison medicine/companion diagnostic environment.
• Understand the communication processes with the notified body and EMA and prepare regulatory team and marketing team, e.g. what to consider in drafting the SSP and the lFU