2025: Looking Back After Almost One Year of the EU JCA

December 1, 2025

The EU Health Technology Assessment Regulation (HTAR) represents one of the most significant shifts in the European health-innovation landscape in decades. Although it entered into force in 2022, its application began on 12 January 2025, starting with oncology products and ATMPs, before gradually extending to orphan medicines, medical devices, and IVDs in the following years.

The ambition is clear:
a single, coordinated EU-level system for HTA, reducing duplication across member states, harmonising methodologies and ultimately accelerating patient access to innovation.
Whether this vision becomes reality remains a matter of debate. Many manufacturers fear the reform might add requirements rather than streamline them. Yet, the reform is now fully mandatory — and its impact is already unfolding.

Two pillars define the new system:

Joint Clinical Assessments (JCAs): EU-level evaluations of relative clinical effectiveness and safety.
Joint Scientific Consultations (JSCs): Voluntary early dialogue with HTA bodies to optimise evidence-generation plans.

Where Do We Stand Now? A 2025 Update

As of 25 November 2025, nearly one year into the operational phase, the system is beginning to take shape:

Joint Clinical Assessments

Nine JCAs are currently ongoing, all for new oncology medicines and ATMPs¹.
The first JCA outcomes are expected in 2026, creating the first real test of how member states will apply “due consideration.”

Major 2025 Development: Implementing Regulation for Devices & IVDs

A key milestone came on 17 October 2025, when the European Commission adopted the Implementing Regulation² detailing procedures and templates for JCAs of medical devices and IVDs.

How JCAs for Devices/IVDs Will Work

Automatic Trigger:
A JCA is triggered once a device receives certification under MDR/IVDR. The HTA Secretariat is notified automatically.
Early Information Phase:
The HTA Secretariat invites the manufacturer (health technology developer) to submit early information about the product.
Scoping (PICO) Timeline:
The JCA Subgroup must finalize the scope (i.e. confirm the PICO and key questions) within 60 days of receiving early information, or within 10 days of the Commission’s formal selection of the device for the JCA, whichever is later.
Optional Scope Explanation Meeting:
Manufacturers may request a meeting to clarify scope decisions, held within 20 days of receiving the scope.
Dossier Submission:
The manufacturer has 100 days to submit the full JCA dossier.
Assessment Timeline:
The JCA Subgroup has 165 days from dossier validation to deliver the joint assessment report.

This creates a structured but tight process, especially given that devices often enter markets with comparatively limited clinical evidence.

How Health-Technology Developers Should Prepare: Insights from Justin Stindt Consultants.

A successful JCA depends on anticipating the PICO well before the formal scoping phase begins. Developers will only have 100 days to prepare their dossier once the scope is final — far too short for major evidence-generation adjustments.

At Justin Stindt Consultants, we support clients through a proven, multi-step preparation strategy:

1. Early PICO Anticipation

We combine:

Secondary research on national HTA precedents
Primary payer research to identify expected national PICOs and clinical expectations

This consolidated view helps manufacturers avoid surprises during the formal JCA scoping phase.

2. JSC (Joint Scientific Consultation) Strategy

Early engagement with EU and national HTA bodies helps refine endpoints, comparators, and evidence generation plans.

3. Benchmarking Against Previous JCAs

As JCA reports become available in 2026 and beyond, analysing precedent cases will become essential for planning robust submissions.

4. Linking EU-Level Assessments to National Market Access

Although the JCA sets a unified EU view on clinical evidence, pricing and reimbursement decisions remain national.
Manufacturers must map:

How each country interprets the JCA
How it influences local P&R processes
Whether additional national evidence will still be requested

This “EU → National” translation is critical for launch sequencing and value communication.

Upcoming: Webinar for Device and IVD Manufacturers

Health-technology developers preparing for future JCAs can join the HTACG Webinar “Webinar for HTDs of medical devices and in vitro diagnostic medical devices” on 12 December.
For asset-specific questions or JCA preparation support, our consultants are available for tailored guidance.

Why Work With Justin Stindt Consultants

Our team specialises in guiding pharmaceutical, biotech, medtech and diagnostic companies through the evolving European market access environment. Our expertise includes: