Dimitris Tzaras | Senior Engagement Manager, Consulting, Precision AQ
The European Union’s Joint Clinical Assessment (JCA) framework is no longer just a pharmaceutical issue. Selected high-risk medical devices and diagnostics are now assessed through a new EU-level clinical assessment process designed to reduce duplication across national health technology assessment (HTA) systems and create a more harmonised approach to evaluating clinical value. For manufacturers, this shift represents one of the most significant market access developments since the introduction of the Medical Device Regulation (MDR).
For medical device and diagnostic manufacturers, JCA is intended to provide a single clinical assessment that can be leveraged across EU Member States, reducing the need for repeated evaluations by individual HTA bodies. The ambition is clear: improve consistency in evidence requirements and support countries with limited assessment capacity, ultimately facilitating more equitable access to innovative technologies across Europe.
Unlike medicines, not every device will undergo a JCA. The framework is limited to specific high-risk categories. Even among these categories, only a relatively small number of products are expected to be selected each year.
Eligibility is first established through existing MDR and In Vitro Diagnostic Regulation (IVDR) classifications, with Class IIb or Class III devices and Class D IVDs being eligible for JCA. Products are then selected against the below criteria:
JCA should not be viewed as a universal requirement for all device manufacturers. Instead, it is a targeted process aimed at technologies considered most impactful from a clinical, public health, or health system perspective. However, the precedents set by these early assessments are likely to influence evidence expectations more broadly across Europe.
The framework could create significant hurdles for manufacturers, and perhaps the most fundamental is timing. Medical device JCAs will operate sequentially rather than in parallel with regulatory review. Unlike medicines, for which regulatory and HTA evaluations can occur simultaneously, device assessments are expected to begin only after CE marking. This could result in a 9- to 12-month gap between certification and publication of a JCA report, potentially delaying access discussions and creating uncertainty for launch planning.
For manufacturers accustomed to treating regulatory approval as the primary milestone, this process introduces a new post-certification phase that may become increasingly important for commercial success.
A second challenge is the mismatch between regulatory and HTA evidence requirements.
The evidence package required for CE marking is often very different from the comparative effectiveness evidence expected by HTA assessors. Manufacturers that focus exclusively on regulatory requirements risk not having important information such as comparative data, patient-relevant outcomes, quality-of-life evidence, or real-world implications for healthcare systems, available when the JCA process begins.
This issue is compounded by the fact that manufacturers have only 100 days to submit their evidence dossier once the PICO framework is finalised. In practice, generating substantial new evidence during this period is unlikely to be feasible, making early planning critical.
There are also important methodological questions that remain unresolved. Many HTA methodologies were originally designed around pharmaceuticals rather than devices. Yet device outcomes are often influenced by factors such as operator experience, learning curves, procedural variation, and service delivery models. Capturing these nuances within a traditional PICO-based assessment framework may prove challenging.
In addition, patient involvement occurs relatively late in the assessment process, which creates a risk that important considerations such as ease of use, quality of life, and day-to-day patient experience may not be fully reflected in assessment priorities or outcomes.
The launch of medical device JCA should prompt a mindset shift. Manufacturers should stop viewing CE marking, JCA, and national HTA submissions as separate activities. Instead, evidence generation strategies should be designed to satisfy all three requirements from the earliest stages of development, which means considering the following long before certification is achieved:
The medical device JCA framework has been designed to improve consistency, transparency, and efficiency across Europe, but it also introduces new evidence expectations and new market access risks.
The manufacturers that succeed will be those that prepare early, align regulatory and access evidence strategies, and anticipate JCA requirements well before CE marking. Those that wait until selection occurs may find that the evidence they need is no longer possible to generate within the available timelines.
As the first device JCAs begin to shape the European landscape, the message for medical device and diagnostic manufacturers is clear: the time to prepare is now, not after certification.
Contact our team today to learn how Precision AQ can help support across JCA activities.