he in vitro Diagnostic Medical Devices Regulation (IVDR) adopted in 2017 updated the rules applicable to in vitro diagnostic (IVD) medical devices for human use on the European Union (EU) market and introduced stricter pre- and post-market requirements, but also added rules on the conduct of performance studies for IVD medical devices. Since the IVDR became enforceable in 2022, developers of both medicines and IVDs (including companion diagnostics) have run into a tangle of challenges.

When Regulations Slow Research

• Clinical trials have been stalled or delayed due to unclear performance study requirements for the IVDs (both companion diagnostics and routine tests) used in clinical trials. According to a 2023 survey on the critical impacts of IVDR implementation on patient access to clinical trials by EFPIA (the European Federation of Pharmaceutical Industries and Associations), up to 42,200 patients may miss access to clinical trials over the next three years, and 89 therapies could be delayed in reaching European patients.
• Navigating separate regulatory frameworks for IVD and medicines clinical development, with no shared timelines or processes and a lack of coordination across EU member states, generates confusion and delays from
  • The lack of coordinated scientific advice for co-development projects such as IVDs and medicines
  • Uncertainty about what requirements should apply (and how) to early-stage trials.

Although the intent of the IVDR was to modernize the regulatory framework for IVDs in the EU and to improve patient safety, its implementation has been challenging and has required specific measures, such as a progressive rollout, to avoid supply disruption of critical IVDs. Many stakeholders have also experienced challenges in the IVDR implementation, including at the interface with the Clinical Trial Regulation (CTR) and the Medical Device Regulation (MDR).

As a result of the European Parliament’s Resolution on the urgent need for IVDR revision, the European Commission initiated a consultation process that closed in March 2025. This article consolidates findings from a DIA Europe 2025 Think Tank which explored if and how the IVD regulation has inadvertently created barriers to innovation.

After an introductory “stage-setting,” this Think Tank divided into separate breakout sessions guided by representatives from EMA and industry plus healthcare professionals. Session participants representing diagnostic developers, researchers, manufacturers, and regulators discussed possible solutions to four specific topics on the impact of IVD regulation that, although designed to protect patients and innovation, have inadvertently created urgent needs for consolidated scientific advice, better governance, more dialogue among stakeholders, and a risk-based approach to the use of IVDs within medicines development.

Four Topics, One Mission: Make IVDR Work for Medicines Innovation

The Think Tank was structured as four moderated discussion groups. Each group explored a different aspect of the IVDR’s impact and how the regulation could be revised to better support early research and combined clinical trials, and facilitate personalized medicines development without compromising patient safety.

Topic 1: Impact on Early-Stage Clinical Trials: Between Safety and Slowdowns

Participants emphasized the need to set clear expectations around the quality and validation of IVDs that would be used in early-phase research:

• IVDR does not envisage a risk-based assessment. Participants suggested that not all tests require the same level of scrutiny because the context of each test matters.
• The “in-house developed tests” exemption does not provide practical flexibility and does not reflect the global nature of clinical research: It excludes non-EU labs and central testing facilities like central laboratories, which especially limits testing in rare/orphan diseases clinical trials where CE-marked tests are generally unavailable.
• Performance studies (PS) are generally impractical in fast-moving early phase or exploratory trials. The IVDR framework does not currently consider the benefit-risk to patients and only uses regulatory considerations generally more relevant outside of the clinical trial context (such as intended use) to evaluate the need for a PS for early-phase research.
• Encourage regulatory “Dialogue over Documentation” to complement and make existing guidance more effective.

Topic 2: Scientific Advice: Bridging the Silence Between Regulators and Developers

This discussion revolved around the urgent need for holistic, meaningful, and timely scientific advice for co-development of IVDs and medicines.

• The current separation of medicines and IVDs regulatory channels is counterproductive in the context of personalized medicine, where availability of IVDs or companion diagnostics is essential.
• Development of a coordinated, inclusive model for providing advice—for example, hosted by a regulatory authority (like EMA or national competent authorities [NCAs]) and including Notified Bodies, NCAs, health technology assessment (HTA) organizations, and manufacturers of medicines and IVDs—would be beneficial.
• Joint scientific advice helps industry plan smarter, provides regulators and Notified Bodies early insight into what’s coming, and could ultimately reduce delays and improve patient access to innovative therapies and diagnostics.
• Using the IVDR revision to formally introduce this joint advice framework also aligns with ongoing initiatives like the COMBINE project, which highlights the priority of scientific advice.

Topic 3: Rethinking Governance Structures to Align Regulatory Pathways for Medicines and Companion Diagnostics

This conversation evaluated complex governance gaps and their proposed solutions:

• Participants stressed that the current system has challenges and provides unclear expectations for clinical sponsors and manufacturers:
• Too many silos and too much fragmentation: There is an urgent need for a cohesive overall vision in current policy to address the existing regulatory fragmentation (i.e., EMA handles the medicinal product side, but Notified Bodies handle the IVD conformity assessment).
• Lack of regulatory predictability and agility is hampering innovation, and interim solutions, not prescribed by the regulations, are not designed for sustainability.
• A “one-stop shop” model presents significant implementation challenges, but the IDEA of a central regulatory body for scientific advice, better harmonization, and dispute resolution is gaining significant momentum among stakeholders.
• Early dialogue is key, especially for rare diseases, and IVDs supporting orphan medicines or undergoing accelerated review require expedited pathways.
• The revised regulation should provide for affordable, appropriate (risk-proportionate) conformity assessment, especially for critical tests with no alternatives.
• More clinical and scientific expertise from medicines should inform the regulatory framework for IVDs to help align it with the pharmaceutical regulatory framework.
• Europe must be more open to international harmonization, mutual recognition and reliance, and international device evaluations, especially in early-stage research.

Topic 4: Clinical Trial Coordination: Untangling the IVDR/CTR Puzzle

This discussion surfaced different ways to improve coordination between the IVDR and the Clinical Trials Regulation (CTR) to make the “combined trial” model of clinical co-development more viable and efficient:

• Align common definitions and concepts between the two.
• The need for a companion diagnostic is generally established after completing the phase 3 clinical trial for the medicine.
• Participants questioned if every IVD used within the context of a clinical trial needs a performance study: What about IVDs that are fit for purpose and have appropriate validation but don’t carry a CE mark?
• Discussants also asked if the definition of intended purpose or use should be interpreted in the clinical trials environment differently than in the marketing environment.
• Procedural differences among EU member states, combined with complex requirements often disproportionate to the scope of the IVD test, currently create additional burdens for sponsors. For example, there is need to align on the scope and appropriateness of double ethical reviews for device studies within clinical trials for combination products.
• The COMBINE program will help address some of these issues, but the learnings from the COMBINE program should be integrated into the IVDR revision.

Think Tank discussants agreed on the value of IVDR’s intentions, as the regulation raises the bar on quality and transparency. However, they also agreed that the revised regulation must be grounded in the reality of today’s research if it is to lay a strong and sure foundation for future research and development for IVDs and medicines in the EU.