What can Legacy Manufacturers Learn from Effective PMS and PMPF Implementation in Order to Prepare to Become IVDR compliant?

Complying with the new EU Requirements for IVD’s is expected to become very challenging for IVD manufacturers and notified bodies, as seen with the transitions applied based on IVD classification over the next few years. However, with manufacturers striving for Per generation and overall IVDR compliance, there are aspects of the IVDR already enforce, the post market surveillance system. IVD manufacturers that have placed the (legacy) IVD’s on the EU market will first need to assess the existing technical and clinical evidence of their legacy device against the requirements of the IVDR. An IVDR Gap Analysis can be used to systematically examining a device’s clinical evidence portfolio to determine whether it demonstrates conformity with all relevant IVDR requirements. It is a crucial first step to determine a device’s evidence from the out-going In-vitro-Diagnostic Device Directive (IVDD) to the new In-vitro-Diagnostic Device Regulation (IVDR) 2017/746. Undertaking an IVDR Gap Analysis will enable the identification of any gaps in the clinical evidence portfolio, allowing measures to be taken to address these gaps before engaging a regulatory body. The second step is to determine how to close the gaps. PMPF activities may include scientific literature searches, feedback from users or even epidemiological studies taking into account, but not limited to, the intended purpose, intended population, and clinical claims/endpoints. The question is how to choose the right PMPF activity(ies)?

The first part of this session (manufacturer led) will provide an overview of the process of the gap analysis and the need for PMPF activities. In addition, we will focus on opportunities and ways to close the identified gaps, with a focus on how and based on which criteria the most suitable PMPF activity can be identified for the particular query. So, leads to manufacturers needing to implement a effective PMS as well as carry out all activities for IVDR QMS compliance and generation of performance evaluation to meet IVDR requirements.

The second part of the presentation deals with the notified body expectations of clinical evidence and the role a PMPF can play in order to gather (additional) clinical data and evidence to support the IVDR application. This will be presented by two representatives of EU Notified Bodies.