The EU HTA regulation is expanding beyond pharma to include device and IVD manufacturers in 2025. JCAs will soon become mandatory for high-risk devices. Manufacturers must prepare now for what’s coming or face difficulties later.
The European Union Health Technology Assessment Regulation (EU HTAR) 2021/2282, adopted in December 2021 and in force since January 2022, will impact medical devices and in vitro diagnostics (IVDs) in 2025.
What’s changing for devices in 2025?
The regulation will extend beyond pharmaceuticals and now cover specific high-risk medical devices and IVDs, introducing Joint Clinical Assessment (JCA) requirements for Class IIb and III medical devices as well as Class D IVDs. The new framework aims to streamline clinical assessments at the EU level, reducing duplication while ensuring faster access to innovative technologies across member states.
Why early preparation matters for medical device manufacturers
To harmonize and expedite access,the regulation establishes a centralized EU-level clinical assessment managed by the HTA Coordination Group (HTACG). Manufacturers are required to submit a single clinical dossier instead of multiple national submissions while standardizing evidence needs across member states.
As a result, medical device manufacturers must adapt to the JCA process, which requires submitting clinical evidence in a standardized format. While national authorities will continue making reimbursement decisions, they will increasingly rely on EU-level assessments, making early preparation crucial. The PICO framework standardizes the assessment process under the new HTA regulation by aligning member states' requirements on ‘Population, Intervention, Comparator, and Outcomes’. Manufacturers must carefully align their clinical development strategies with these parameters to meet varying national expectations within a unified European process.
*HTD = Health Technology Developer
Key dates and regulatory milestones
The timeline for implementation is rapidly approaching.
In January 2025, the European Commission adopted the implementing act for Joint Scientific Consultations (JSCs), outlining the rules for conducting coordinated EU-level consultations. These include details regarding:
- How medical device manufacturers can submit consultation requests.
- How stakeholders, including patients, clinicians, and other experts, are selected.
- How medical device developers request JSCs with the EMA alongside expert panel reviews.
The first JSC for medical devices and IVDs will take place in June 2025, allowing early engagement with regulators. The implementing act for JCAs will be published in the coming months, establishing the framework for JCA implementation and outlining the crucial next steps for its execution.
How we can help medical device and IVD manufacturers
Given the changing regulatory landscape and the need for robust clinical evidence, early engagement is essential. At Simon-Kucher, we help medical device and IVD manufacturers navigate these challenges by providing strategic guidance on organizational readiness strategies and roadmap planning for successful execution. The EU HTA framework represents a shift toward greater consistency, but it also introduces complexities that require expert navigation. Now is the time to act.
Get in touch with us to ensure your medical devices and IVDs are fully prepared for the coming changes.
Curious how pharma is preparing for the EU JCA? Read what industry leaders shared with our EU HTA experts.
Special thanks to Clara Beggerow for her contributions to this article!
