EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation

The Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), now fully applicable since 26 May 2022, introduces substantial changes to the diagnostic sector. EFPIA fully supports this new legislation aiming at ensuring a high level of public health and patient safety in Europe.

However, there are still critical challenges to address when it comes to clinical trial initiation in Europe for therapies that require the use of an in vitro diagnostic (IVD) in a trial. As of today, neither the streamlined process created by the IVDR to facilitate the review of applications for IVDs used in clinical trials, nor  the supportive infrastructure and the guidance needed to enable companies to evolve in a fully reliable and operational environment, are in place.

EFPIA would like to call on the Commission to address these challenges to avoid any unintended consequences that may ultimately lead to a reduction of clinical trial sites in Europe, as well as delayed access to novel therapies for European patients who have exhausted all other treatment options.

EFPIA stands ready to participate in a constructive dialogue with the European Commission and key stakeholders to discuss these important challenges, potential solutions and inform future guidance that will enable the optimal use of IVDs in clinical research.