From IVDR implementation challenges to a forward-looking strategy

Since the application of IVDR, the in vitro diagnostics sector has operated under significant regulatory pressure. Capacity constraints, uncertainty regarding performance evidence expectations and divergent national interpretations have created a demanding environment for manufacturers, particularly those developing innovative or niche diagnostics. Against this background, the IVD Medical Device Roadmap represents a notable change in regulatory tone.

Rather than focusing solely on compliance gaps, the roadmap articulates a forward-looking vision for how regulatory science, innovation policy and public health needs should evolve together under IVDR.

A roadmap designed as a living document

One of the defining characteristics of the roadmap is its explicit designation as a living document. This reflects the Commission’s acknowledgement that the IVD landscape is changing rapidly, driven by advances in genomics, personalised medicine, software as an IVD and artificial intelligence. As a result, regulatory expectations related to performance studies and clinical evidence cannot remain static.

For manufacturers, this signals a regulatory environment in which guidance, scientific dialogue and iterative refinement will increasingly shape expectations, rather than infrequent legislative revisions.

Strengthening regulatory science under IVDR

A central pillar of the roadmap is the strengthening of regulatory science capabilities for IVDs. Planned actions include the establishment of integrated application pathways for companion diagnostics and medicinal product clinical trials, as well as the publication of best practice guidance for innovative IVD technologies such as genetic testing, pharmacogenomics and software-based diagnostics.

This approach aims to support more consistent, science-driven regulatory decision-making and to reduce uncertainty around evidence requirements for novel technologies.

Rethinking performance evidence and clinical data requirements

The roadmap places strong emphasis on refining how performance and clinical evidence are generated and assessed under IVDR. Rather than applying uniform expectations across all IVD categories, it promotes a differentiated approach based on risk class, intended purpose and clinical context.

Key areas of focus include:

  • guidance on risk-based approaches to performance evidence for different types of companion diagnostics,
  • increased acceptance of innovative and adaptive study designs,
  • clearer integration of analytical performance, clinical performance and scientific validity.

This direction closely aligns with broader IVDR reform discussions and reinforces the transition towards lifecycle-based evidence generation.

Supporting innovative IVD technologies

Beyond regulatory compliance, the roadmap explicitly addresses innovation enablement. Planned initiatives include expanding the portfolio of biological standards and reference materials, including in silico tools, and strengthening collaboration with research institutions working on novel biomarkers, cancer genomics, dementia diagnostics and antimicrobial resistance.

For manufacturers developing advanced diagnostics, these initiatives may significantly influence development feasibility, timelines and regulatory predictability.

Pandemic preparedness and system resilience

Pandemic preparedness is another key theme of the roadmap. Drawing lessons from recent global health crises, the document outlines measures aimed at ensuring that diagnostic regulatory frameworks can rapidly adapt to emerging public health needs while maintaining robust safety and performance standards.

This includes closer alignment with international clinical evidence frameworks and improved cooperation with global regulatory partners in emergency situations.

Implications for manufacturers’ regulatory strategies

For IVD manufacturers, the roadmap provides valuable insight into future regulatory priorities. It suggests that successful IVDR strategies will increasingly depend on:

  • early alignment with regulatory science initiatives,
  • proactive engagement with competent authorities and notified bodies,
  • flexible performance evidence plans capable of adapting to evolving guidance.

Manufacturers that treat the roadmap as a strategic planning tool rather than a purely informational document are likely to be better positioned as IVDR implementation continues to mature.

Alignment with broader EU regulatory developments

The IVD Medical Device Roadmap should be read in conjunction with the proposed MDR and IVDR reform and the MDCG guidance on breakthrough devices. Together, these initiatives point towards a more coherent, risk-based and innovation-aware regulatory environment for medical technologies in the EU.

They collectively signal a gradual transition from rigid, procedure-driven regulation towards a more dynamic and science-led system.

Strategic conclusions

The In Vitro Diagnostics Medical Device Roadmap represents an important milestone in the evolution of IVDR implementation. By clearly articulating priorities in regulatory science, performance evidence and system resilience, it provides manufacturers with an opportunity to anticipate regulatory expectations rather than merely respond to them. For the IVD sector, the roadmap signals a future in which innovation, preparedness and regulatory robustness are increasingly aligned within the European Union.