On December 16th the European Commission released a proposal to amend the Medical Device Regulations (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulators (EU) 2017/746 (IVDR) (link). This proposal comes as a great relief to the biopharma industry as it simplifies the regulatory burden of introducing novel diagnostics to support precision medicine clinical trials in the EU. The changes within the proposal importantly preserve patient safety while addressing bottlenecks in the process that have contributed to fewer clinical trial starts for precision medicine clinical trials in Europe relative to the rest of the world. Discovery Life Sciences (Discovery) strongly supports the timely passage of these updates, which include important clarification regarding the use of in-house devices in clinical trials.

Important updates relevant to Discovery and the clinical trials industry include:

  • Recognition of the importance of in-house devices in supporting clinical trials and reducing regulatory burdens for their use
  • Recognition that Contract Research Organizations (CROs) can offer in-house devices to support clinical trials without the need for a Performance Study
 

The 2022 implementation of IVDR provided a more robust framework for development of new diagnostics and greatly enhanced the quality of IVDs available to European patients. While well-intentioned, the impact of these regulations has simultaneously increased costs and startup timelines for EU-based clinical trials requiring the prospective use of novel biomarker assays, and recent industry publications indicate that this is one factor in the reduction in the utilization of Europe for clinical trial sites (link, link).

In-house devices – diagnostic tests developed within a single laboratory – were used extensively to support EU-based clinical trials prior to the implementation of IVDR. These devices provide a streamlined pathway to implement novel tests into clinical trials for prospective patient use, which is an important first step in the development of new precision medicines and companion diagnostics.

IVDR greatly restricted the ability to utilize in-house devices in clinical trials, essentially limiting use to qualified health institutions or hospitals, and mostly eliminating this option for CROs or research laboratories focused on clinical trials. Instead, the only pathway for biopharma or diagnostics companies to introduce novel diagnostic tests post-IVDR implementation was through a Performance Study, which can easily add 6 months or more to study startup. This has led to extensive industry concerns of delays, higher costs, and regulatory uncertainty.

The proposed updates to IVDR recognize the importance of in-house devices to support access to novel testing technologies and expands the Article 5(5) exemption that permits in-house devices for health institutions to be expanded to include laboratories that focus solely on testing to support clinical trials. This change will allow CROs to offer in-house devices to support clinical trials, which has mostly been impossible since 2022 and limited most device studies conducted by CROs to the more lengthy and costly Performance Study pathway.

While not yet implemented, this update validates the operating model that Discovery has utilized since IVDR came into effect in May 2024: utilization of in-house devices under our Health Institution exemption to provide testing for novel biomarkers in human clinical trials. This proposal is good news for our clients who have implemented biomarker testing services through Discovery, as it reduces regulatory risk and the possibility that a lengthier device Performance Study will be required to support their clinical trials now and in the future. Furthermore, it signals a change that permits greater industry confidence to utilize in-house devices in clinical trials to reduce complexity and speed up time to first patient first visit.

Discovery is committed to efficient and compliant development and deployment of novel biomarker assays to support clinical trials in the EU. Our unique position as a qualified health institution in Kassel Germany and strong history of developing in house devices to support our client’s clinical trials means that we are well positioned to continue this approach until passage of these updates by the European Union.