JCA Dossier vs CEAR for Medical Device Developers: New Challenges on the Horizon

A first glimpse at the proposed JCA dossier template required for selected medical devices.

In June 2025, the draft implementation act for the Joint Clinical Assessment (JCA) for medical devices was released to the public for comments and feedback. The proposed JCA dossier template was also available for review as part of this open consultation. In this article, we outline what medical device developers might expect to change, in light of these new proposals and the existing clinical evaluation assessment report (CEAR).

A recap on JCA, and how it will affect medical devices developers

• Starting from 12 January 2025 and every 2 years thereafter, medical and in vitro diagnostic (IVD) devices meeting the Regulation (EU) 2021/2282 criteria will be chosen for Joint Clinical Assessment (JCA).¹ Check out the first instalment in our JCA series: Riding the First JSC Wave.
• Selection factors will include unmet need; first in class; public health or healthcare systems impact; artificial intelligence (AI)-based software, significant cross-border dimension; and Union-wide added value.¹
• Under the current proposals, medical device developers will need to submit the JCA dossier within 100 days of notification.
• The JCA dossier compiles clinical evidence on the therapeutic area, efficacy, safety, and performance of the therapy. It will also reference the clinical evaluation assessment report (CEAR) as well as any other clinical evaluation documents.
• While overlapping with the CEAR regarding clinical efficacy and safety elements, the JCA requires additional detail and strategic considerations.

1) Explicit information required on target medical condition, and clearer product positioning

The JCA dossier for medical devices requires manufacturers to submit a detailed overview of the medical condition. It particularly emphasizes the patients’ perspective and lived experiences, as well as the societal implications of the target disease. The product’s position in the current clinical pathways should also be outlined. These elements are not explicit in the CEAR, which is limited to specifying the intended purpose with regard to the target patient population and medical condition to be diagnosed, treated, and/or monitored.

What are the implications?

• To communicate a more holistic overview of the disease, which frames the positioning of the product, activities such as targeted literature reviews, patient engagements, clinical ad-boards and, potentially, real world market research will need to be prioritized for incorporation into the JCA dossier. These activities may be new for some developers, and for others these activities may require a more thorough and rigorous approach.
• The quality of the evidence, including methodological considerations for qualitative research, should be proactively considered to justify the intended position and use of the product in the current patient pathway.
• Manufacturers should focus on providing strong evidence in support of a credible value proposition. A coherent, extensive, and well-thought-out value dossier will be synergistic in both fulfilling the requirements of the JCA dossier and supporting product launches.

2) Multiple PICOs, and more PICOs

The JCA report serves as a comprehensive and central document for all member states to consider in their local health technology assessment (HTA) processes. As such, it must consider the diverse populations, treatment pathways, and standard of care across European markets. A single assessment is therefore likely to include multiple PICOs (population, intervention, comparator[s], outcome[s]). In a PICO exercise conducted by the JCA subgroup in 2024, the number of PICOs identified ranged from one to five for three separate medical devices.²

Unlike the CEAR – which does not use an explicit PICO framework and where the relevancy of content is primarily determined by medical device developers themselves – the PICOs required in the JCA dossier are explicit. PICOs and evidentiary requirements will be determined by the JCA assessor and co-assessor as part of the final assessment scope, and medical device developers must submit the requested evidence, or provide justification if any data elements are not submitted.

What could this mean?

• We anticipate a quick turnaround between the release of the final assessment scope and submission deadline, based on our experience with the JCA for medicinal products as well as the draft implementation act. As such, some developers will need to factor in new activities, which the company might not have incorporated yet into standard procedures for access.
• Medical device developers need to prepare early for JCA in order to meet the final PICO requirements, including PICO prediction across European markets and preparation of data from trial-based clinical efficacy and safety studies.

There may be significant imbalances between the available evidence to support each PICO and what is available in reality. Development of risk mitigation and response strategies to PICO selection with evidence gaps or challenges will be crucial for success.

3) A move towards higher quality evidence, methodological rigor, and comparative data

As part of the JCA process, there is an explicit focus on the provision of higher-quality evidence that is directly appropriate for clinical assessment and decision-making across all member states. Adding to this is the requirement for a direct and indirect comparative evidence package, including detailed and transparent information around the study protocols and statistical analysis plans for comparisons against current standard of care. Specifically, indirect comparisons are required to demonstrate comparative effectiveness for medical devices against comparators in the absence of a head-to-head trial, which may pose substantial methodological and data challenges. The methodological guidelines for JCA are more detailed than those required for the completion of the CEAR.

What could this mean?

• Advanced planning and additional resources will be required to provide the volume and standard of information expected in the JCA dossier. The provision of detailed information and evidence must be considered alongside the value messages supporting the product’s positioning and added value in the market.
• A greater degree of cross-functional collaboration and engagement would support alignment on key decisions with strategic implications, such as the conduct of supportive analyses including indirect comparisons, provision of proprietary information, presentation of analytical outputs, and interpretation of results.
• There may be value in seeking advice from external experts regarding analysis plans, methodological approaches, and the extent of data uncertainty within a given JCA.
• Although the JCA dossier comes with more stringent evidence requirements, there is an opportunity to make use of the relevant synergies and efficiencies while developing the CEAR and JCA dossier in parallel.

Conclusion

Despite overlap in their clinical efficacy and safety data considerations, the JCA differs from the CEAR in terms of its core purpose. The JCA demands high-quality evidence that is directly relevant to all member states, including clear disease context and product positioning, assessor-defined multi-PICO evidence requirements, and transparency in the provision of information and methodological requirements for comparative evidence suitable for use in local HTA decision-making. Teams that prepare early, align research activities with these expectations, and build synergies between the CEAR and JCA will be best placed to meet timelines and support local market access in Europe. We consider the following elements to be critical to achieving success:

• Early PICO prediction
• Increased cross-functional collaboration and expert input
• Planning timing of activities between JCA and CEAR
• Higher quality qualitative and quantitative evidence
• Ready datasets and trial-based analyses across multiple PICOs
• Information for study protocols and statistical analysis plans following PICO framework requirements
• Proactive conduct of direct and indirect comparisons
• Preparation of mitigation plans and tactics to plug evidence gaps

Fundamentally, the road to approval for medical devices remains distinctly different to that for medicinal products.^1,3 However, similarities are emerging in the proposed processes based on this draft implementation act for medical devices.

At Lumanity, we’re actively tracking JCA developments and will continue to share timely insights to support your decision-making. Watch this space for the next instalment, in Q4, where we’ll explore the practical impact of JCA requirements and what they mean for your EU strategy