Comparing joint clinical assessment (JCA) and joint scientific consultation (JSC) pathways for medicinal products and medical devices/in vitro diagnostics

Insights from the European Commission webinar on 12 December 2025

The implementation of the EU Health Technology Assessment Regulation (EU HTAR, Regulation (EU) 2021/2282)² affects not only developers of medicinal products (MPs), but also those developing medical devices and in vitro diagnostics (MD/IVDs). 

The European Commission (EC) conducted a webinar which provided clarity on the mechanics of the JCA and JSC processes, but more importantly, on how these will operate differently for MPs versus MD/IVDs.¹ These operational insights represent a shift from purely regulatory interpretation to practical expectations for developers. 

 Webinar discussion focused on a small-scale pilot conducted by the HTA Coordination Group (HTACG), that informed the official guidance on MD/IVD selection for JCA. While detailed results were not published, the webinar highlighted practical post-pilot insights for developers, including the suitability of selection criteria, process transparency, and effective JCA subgroup discussions, despite tight timelines. 

Important differences are starting to emerge on how JCAs and JSCs will operate for MPs and MD/IVDs. There are three distinct areas in the EU JCA process that differentiate the approach for MD/IVDs compared with MPs:  

1. Regulations regarding selection and eligibility into the JCA process differ between MPs and MD/IVDs 
2. Evidence expectations may differ for MD/IVDs due to the clinical impact measure  
3. The appropriate use of JSCs for MD/IVDs will need need to account for their device‑specific consultation pathway 

1. Selection of MD/IVDs for JCA is criteria-driven, not automatic 

For MPs, JCA participation is mandatory and directly linked to European Medicines Agency (EMA)‑regulated product categories. As per Article 7(1) of EU HTAR, from January 2025, all new oncology medicines and Advanced Therapy Medicinal Products (ATMPs) automatically fall within scope, followed from January 2028 by orphan MPs and from January 2030 by all remaining new MPs.² This creates a predictable pathway anchored to EMA milestones and timelines. 

This process creates a markedly less predictable pathway for MD/IVDs compared with MPs. Without procedural anchors equivalent to EMA milestones, MD/IVD developers face a great deal of uncertainty around both the timing of the assessment and if the assessment will actually occur. This is further compounded by the timing of the selection. Notification to developers on their selection into the JCA process comes late in the development program and makes it harder to anticipate and align their evidence generation tactics with potential JCA requirements.

To increase predictability, MD/IVD developers should proactively assess alignment with EU HTAR selection and eligibility criteria, identify gaps through structured readiness assessments, and increase visibility in EU level processes that act as selection signals, such as horizon scanning and Expert Panel submissions. 

2. Evidence requirements for MD/IVDs are more heterogeneous and require device‑specific justification

Under EU HTAR, both MPs and MD/IVDs must demonstrate comparative clinical effectiveness aligned to Population, Intervention, Comparator, Outcome (PICO) principles. For MPs, assessments typically rely on:

• Randomized controlled trials (RCTs), considered the gold standard for estimating intervention effects 
• Single arm trials, where RCTs are not feasible 
• Indirect treatment comparisons
• Real world evidence supporting the comparative effectiveness context 
• Established clinical and patient relevant endpoints

For MD/IVDs, evidence is often more heterogeneous and may draw on:

• Clinical performance evaluations including, where relevant, AI enabled devices, efficiency and workflow related parameters
• Interventional or observational studies and registries
• Registries and real-world performance data
• Operator-dependent outcomes
• Post-market follow-up plans (PMCF/PMPF)

Payers typically associate non-randomised evidence with greater uncertainty; given this type of evidence will likely predominate in many MD/IVD submissions, developers should be prepared to clearly contextualise and justify its use.

During the webinar, the HTACG noted that the exact number of PICOs for any given MD/IVD cannot be predicted in advance, because it depends on the device’s characteristics and intended use. However, the expected range is broadly aligned with what was seen in the EC’s PICO exercises published in February 2025⁵. In those exercises, the MD/IVDs assessed required between one and five PICOs, reflecting differences in clinical complexity and comparator variability.

To operate effectively within this evidence landscape, developers should:

• Prepare core evidence components early where eligibility appears likely
• Recognize that JCA evidence preparation also supports national payer discussions
• Use early internal feasibility and PICO mapping to anticipate comparator and data challenges

3. The JSC process has distinct eligibility and consultation pathways for MPs and MD/IVDs

While both MPs and MD/IVDs may access JSCs under EU HTAR, the structure and practical application of these consultations differ.
For MPs, JSCs are closely aligned with EMA scientific advice and are limited to products within future JCA scope where pivotal studies are still being planned. The purpose is to allow HTACG input into protocol design before evidence generation begins.

For MD/IVDs, JSC eligibility is restricted to high‑risk technologies and may apply to both pre‑certification and justified post‑market studies. Importantly, MD/IVD JSCs can run in parallel with MDR/IVDR Expert Panel consultations and may involve notified bodies as observers. A dedicated pre‑submission meeting supports preparation of the device‑specific briefing package.

These design features were presented as intentional mechanisms to address the complexity of device development and regulatory interaction. 

Looking ahead

According to the HTACG 2025 Annual Report (published 16 February 2026)⁶, no JCAs for MD/IVDs were initiated in 2025, as the year focused solely on preparatory work for device assessments beginning in 2026. In addition, no JSC requests were received from MD/IVD developers in 2025, despite the 2025 HTACG Annual Work Programme estimate range between one and three device JSCs. This suggests that JSC activity has primarily focused on MPs, with MD/IVD implementation still in an early operational phase. However, this may change with the first JCA for a device forecasted to go live in 2026.

The first MD/IVD JCA could begin as early as June 2026, pending formal selection decisions. Up to 15 MDs may be eligible for JCA in 2026 (based on Emerging Health Technologies Report⁷), and between two and five MD/IVD JSCs are planned for 2026, with plans to expand capacity in coming years.

While MPs continue to dominate the near-term JCA landscape, 2026 will be the inflection point where MD/IVD JCAs move from theoretical to operational, requiring a level of evidence discipline and cross-functional coordination that many device developers have not historically needed. Developers should already be assessing whether technologies are likely to meet HTAR selection criteria, considering where JSC may add value, and ensuring evidence plans are sufficiently mature to respond if an assessment is triggered. This requires coordination across regulatory, clinical, and market access functions well before formal assessment begins.

Parexel supports developers in translating emerging EU signals into actionable strategy, from early evidence planning and JSC preparation through to dossier readiness and broader EU HTA engagement. We are always ready for a conversation. 

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This article is provided for educational purposes only and should not be considered or relied on a legal or regulatory advice.
 

References:

1. The EU HTA Regulation: Webinar for health technology developers of medical devices and in vitro diagnostic medical devices - Public Health
2. The EU HTA Regulation: Implementation of the Regulation on Health Technology Assessment - Public Health
3. Regulation - 2017/745 - EN - Medical Device Regulation - EUR-Lex
4. Regulation - 2017/746 - EN - IVD - EUR-Lex
5. PICO exercises - Public Health - European Commission
6. HTACG Annual Report 2025
7. New report on Emerging Health Technologies - Public Health

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