From Regulation to Reality: A New Era of HTA for Medical Devices Begins 

The long-anticipated EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282) was implemented on 12^th January 2025.¹ The key aims of the EU HTA regulation are outlined in Figure 1.^1,3 In 2025, the Health Technology Assessment Coordination Group (HTACG) plans to initiate 1–3 Joint Scientific Consultations (JSCs) for medical devices (MDs), with a gradual increase in offerings in subsequent years. The first recommendation for the selection of MDs and in vitro diagnostic medical devices (IVDs) subject to Joint Clinical Assessment (JCA) is planned in Q1 2026.²    

In response to the EU HTA Regulation, EU countries are actively collaborating to enhance the evaluation of health technologies, such as medicines and medical devices.On the 21^st of January 2025, the EU Health and Digital Executive Agency (HaDEA) signed a new framework contract with a consortium of HTA bodies representing 21 EU countries.⁴ The consortium, led by the Belgian INAMI-RIZIV, will conduct JCAs and JSCs. The contract will last for 48 months totalling €35 million under the EU4Health programme. 

While pharmaceutical companies have already started adapting to the new EU HTA regulation, MD manufacturers must now prepare for the upcoming changes to avoid potential delays and ensure successful market access. The introduction of JCAs and JSCs for MDs marks a significant shift requiring developers to engage early and align with evolving HTA expectations. 

What is changing in the EU HTA for Medical Devices? 

JCAs 

The EU HTA Regulation states that high risk MDs and IVDs including Class III, Class IIb and Class D IVDs will face mandatory JCAs. The HTACG will recommend MDs and IVDs for evaluation based on criteria such as unmet medical needs, first-in-class innovations, public health impact, AI usage, and cross-border relevance every two years.¹ 

JCAs will evaluate the clinical effectiveness and safety of MDs. Developers are required to submit a dossier containing clinical evaluation data from regulatory assessments, scientific opinions from expert panels, and both published and unpublished clinical studies as well as registry data, if available.¹ Currently, there is limited guidance on this process, but more is expected to be published later this year (Table 1). 

Implementing acts 

Guidance documents by HTACG to be released 

JSCs 

To understand the data requirements for JCA submissions, developers can request a JSC for guidance from the HTACG on clinical study design, comparators, interventions, health outcomes and patient populations. The HTACG will notify the developer within 15 working days about engaging with a JSC, which can run in parallel with EMA scientific advice.¹  

On 24^th January 2025, the implementing act on JSCs for MDs and IVDs was published (Regulation (EU) 2025/117), which outlines the key steps for JSCs (Figure 2).³ Additionally, the implementing act indicated that the HTACG will organise requests for JSCs, setting request periods by 30^th November each year. There will be at least three request periods per year, except in 2025 when there will be only one period set from 2^nd – 30^th June. 

Why this matters? 

From our experience with companies preparing for JCA requirements, those that begin the process early are likely to navigate the transition efficiently, ensuring their products are evaluated and reach the market without delays. By proactively engaging with the JSC process, manufacturers can fine-tune their clinical development plans to align with JCA requirements, reducing the risk of evidence gaps that could slow down approvals. Additionally, early preparation will allow companies to streamline their internal workflows, ensuring that regulatory, clinical, and market access teams are fully coordinated in their approach to EU-wide submissions. For example, companies can: 

• Leverage JSCs for Strategic Advantage – Engaging in JSCs early allows companies to align their clinical studies with JCA requirements, reducing potential hurdles later. 

• Assess Internal Capabilities – Companies should evaluate whether they have the relevant expertise and resources to manage these new demands.  

• Leverage real-world evidence (RWE) for competitive edge – RWE from registries, post-market studies, and real-world usage can support JCA submissions and help demonstrate long-term value enhancing HTA outcomes and payer confidence. 

What should companies do in the meantime? 

To effectively navigate the evolving EU HTA landscape and prepare for upcoming JCAs, companies should companies should take the following strategic steps:  

• Track JSC Timelines – The first JSC request period will be set between 2^nd and 30^th June 2025. Stay updated to ensure you don’t miss key deadlines. 

• Engage in JSCs Early – If your MD or IVD is high-risk, consider requesting a JSC to receive valuable scientific advice and align clinical development with JCA expectations. 

• Strengthen Your Clinical Strategy – Ensure clinical trial design meet both regulatory and JCA requirements and assess the availability of RWE to avoid evidence gaps later. 

• Evaluate Your EU HTA Readiness – Do you have the internal expertise to handle JCAs and JSCs? If not, engage with HTA and regulatory experts. 

For further information on how to start planning and implementing changes immediately in preparation for EU HTA, watch our webinar on taking action. For more tailored help, get in touch to see how Remap can help develop materials for JSCs and JCAs or provide bespoke training. 

References: 

1. https://eurlex.europa.eu/eli/reg/2021/2282/oj/eng  
2. https://health.ec.europa.eu/document/download/73e4bac1-1e99-4c82-b758 eeb227f35b86_en?filename=hta_20250228_flash_en.pdf  
3. https://eur-lex.europa.eu/eli/reg_impl/2025/117/oj/eng   
4. https://hadea.ec.europa.eu/news/theory-practice-implementing-eu-health-technology-assessment-regulation-2025-01-22_en   
5. https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-scientific-consultations_en  
6. Rolling plan – Implementation of the Regulation on health technology assessment