Proposals can cover all types of health technologies, aiming to define improved and novel sources of evidence with proven relevance for regulatory decision-making with a focus on safety and performance throughout their lifecycle, i.e. throughout the continuous process of clinical evaluation.

To this end, proposals should address either, or a combination of the following:

1. the improvement of existing methodologies and their fitness to specific types or classes of health technologies, including methodology for regulatory assessment and
2. explore and examine to which extent novel information sources as indicated above can be considered as evidence that is satisfactory in view of regulatory needs concerning safety and performance.

Proposals should support the update and refinement of regulatory science on health technologies and contribute actionable information that can be used for improved or novel regulatory policies, rules, guidance documents and other tools with a view to ensuring that European patients and healthcare professionals have access to safe and effective innovative health technologies. Proposals should ultimately contribute to a regulatory environment that makes use of the full spectrum of novel biomedical and bio-digital approaches for clinical investigation and evaluation, while promoting a patient-centred approach to health technology innovation, facilitating the timely entry to market of performant and effective innovations and support their uptake in the health systems and clinical workflows without compromising patient safety.

Applicant consortia should reflect a broad representation of stakeholders, notably clinical societies, academia, notified bodies, industry, patients and regulators and the proposed work should address one or more of the following elements:

• Data and analyses on how existing approaches in regulatory science can be refined and improved in view of closing existing gaps of clarity, sufficiency of clinical evidence, generated on the basis of clinical studies and clinical investigations.
• Data and analyses on whether and to which extent novel information sources from biomedicine including new approach methods and digital and AI-enabled models and approaches can contribute to the clinical evaluation of innovative health technologies, e.g.:
  • By providing information on relevant biophysical, anatomical, physiological and other disease-relevant aspects.
  • By supporting information integration through the use and aggregation of already existing data, including clinical ones, from similar types or groups of technologies (e.g. retrospective information in registries, data collections, including Real-World Data (RWD)[1] from using technologies that have characteristics that are relevant for innovative technologies).
  • By supporting improved planning and design of first-in-man clinical studies, with a view of enhancing the effectiveness and the safety of such studies and rationalising the use of resources of all involved actors by focusing the generation and assessment of clinical data on health technologies for which those data are indispensable.
• Data and analyses that examine to which extent the above-mentioned points can support the development and uptake of innovative technologies for unmet medical needs and for special patient populations (e.g. paediatric and rare conditions) via dedicated regulatory pathways and/or within a structured framework enabling their development and testing in a real-world environment under regulatory supervision (“regulatory sandbox”).

The actual conduct of clinical studies is not in scope of this topic.

The activities should cover and draw on all the relevant healthcare innovation related frameworks other than pharmaceutical products, i.e. medical devices, in-vitro diagnostics, AI, and Substances of Human Origin (SoHO).

The starting point is a good understanding of the innovative technology and of its inherent risks, so that appropriate safety and quality requirements can be applied for monitoring the outcome in the relevant healthcare setting. As the number of hybrid or combinations of health technologies increases and technology integration becomes rather the norm than an exception in health innovation, the current segregated, technology-specific, frameworks may not provide a clear path forward for the health technology that is targeted. To that end, when considering an innovation, it is important to consider all relevant legislative frameworks including MDR and IVDR, the proposed SoHO-Regulation, and AI Act among others.

Proposals are encouraged to consider, where relevant, the data, expertise and services offered by European research infrastructures especially those active in the health domain, such as EATRIS ERIC, and also the findings of previous EU-projects (e.g.: CORE-MD).