The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene.

Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs.

In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1.

The IVDR came into effect on 26 May 2022, replacing the EU Directive for IVDs. Although the IVDR was intended to ensure patients’ safety while also improving the transparency needed to deliver access to innovative medical technologies in the EU, its implementation is missing guidance and coordination, said Oppermann.

Notably, the central study submission infrastructure EUDAMED will not be entirely functional until as late as 2027, which means that companies now have to work with EU member states that have different processes for the submission and approval of required Clinical Performance Studies (CPS). Now, IVDs used in clinical trials need to demonstrate safety, validity and clinical performance in CPSs.

These performance studies place high demands on sponsors, with multiple document requests. What’s more, such studies are also required for early Phase I and Phase II clinical trials where companies need to develop IVDs if there are no available off-the-shelf options, based on the presentation.

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According to Oppermann, the new regulation has a much broader scope when it comes to both clinical trials and commercial assays. The percentage of IVDs that require oversight from a notified body, institutions that assess the conformity of products, grew from between 10% – 20% to 80% – 90%, based on the presentation. While the previous directive considered assays used in clinical trials as out of scope, the new regulation now affects them.

Citing data from a survey carried out by the European Federation of Pharmaceutical Industries and Associations (EFPIA), 43% of EFPIA’s member companies estimated a 6 – 12 month delay caused by IVDR. Additionally, 48% out of the 21 member companies that responded to the survey estimate that there could be a potential 6­­­­­­­ ­– 12 month delay over the next three years, based on the presentation, while 86% said oncology is the most affected field.

At the moment, one option that is being considered is to use in-house IVD within health institutions, said Oppermann. Health institutions are defined as organisations whose primary purpose is the treatment of patients or the promotion of public health. However, contract research organisations (CROs) and central labs could be potentially considered as health institutions, per the presentation.  According to Oppermann, while possible, this collaboration would require clear communication to avoid any trial delays.