Description: The EU IVDR became applicable as of 26 May 2022 and requires all IVDs on the European market to obtain new CE marking under the IVDR that contain many new requirements, in the majority of cases by conformity assessment by a notified body. In the EU Regulations, more specifically the IVDR, innovative devices of which the scientific validity has not been fully demonstrated may follow a different path as compared to devices that intend to measure a more established analyte or marker. In addition, the EU Regulations does not foresee in a definition of “orphan devices”, let alone “orphan IVD’s”. For this category, there is a real patient need to get these “orphaned device” onto the EU market.
For a well-established analyte or marker, the association with a particular disease or condition is commonly accepted and well described in various sources. However, with the changes in requirements under IVDR, innovation with novel markers is a extreme challenge. The IVDR states the use of proof-of-concept studies can be used to establish a link between a novel analyte or biomarker and a particular clinical condition/physiological state (Annex XIII 1.2.1), thereby confirming scientific validity especially when Scientific literature is not readily available. Moreover, the definition of proof-of-concept studies, including guidance on how they should be conducted, is not provided in IVDR or corresponding guidance. This presentation is focused on giving an oversight of the current challenges but also opportunities for innovative and orphan IVD devices getting to market.
Objective of the session is to create awareness of the regulatory challenges that are connected to bringing innovative and orphan IVD’s to the market in the EU. In addition, bringing the message that IVD manufacturers should already prepare for regulatory changes that are expected in the future. Elements that are going to be covered are:
• Basic categorization of innovative IVD’s and, more specifically, “orphan IVD’s” and the challenges of bringing these devices to the EU market • Discussing the main differences of both EU regulation and the US Regulations (HDE) on how “orphan IVD’s” are treated and how this potentially affects conformity assessment of IVD’s in the EU in the future. • Describe the regulatory strategies IVD manufacturers can take to overcome the hurdles of demonstrating scientific validity and clinical performance for their innovative device • Understand how manufacturers are demonstrating scientific concepts and what types of studies manufacturers could carry out to obtain data, while continue to innovate in Europe
