Health technologies, including medical devices (MDs), are essential in improving the quality of life and health of patients. To assess their value, cost-benefit, and price-reimbursement decisions, each Member State of the European Union (EU) has its own health technology assessment (HTA) system. The evaluation of the scientific evidence on which these HTAs are based considers slightly different parameters in different countries, which entails different requirements and reports by the developers of these technologies.
With the goals of avoiding duplication and inefficiencies within the EU, making it easier for patients to have access to innovative technologies as soon as possible, and improving the quality and transparency of the HTA process, the EU HTA Regulation (Regulation (EU) 2021/2282) was published on 11 January 2022, and began to apply on January 12, 2025 (1).
This regulation includes a series of procedures for cooperation between countries, establishing a unified mechanism for the presentation of scientific evidence, and for carrying out a Joint Clinical Assessment (JCA). The idea is to cover all the possible questions of each national system, so that each competent authority can then use that report as a single source for their own HTA assessment. It utilizes the PICO system, which stands for “patients”, “intervention”, “comparators” and “outcomes” (2). These European assessments will not include economic value judgments, but are intended to be the unified source of scientific evidence so that each Member State can then make its own decisions on added value, economic evaluation, and price reimbursement according to the context of each country (1).
For products that are in development, the possibility of a Joint Scientific Consultation (JSC) is offered, to plan clinical development and align the strategy to the parameters that are expected to be assessed in the future JCA once the product has obtained the CE marking (1).
Which Medical Devices are Affected?
JCA will be limited to some MDs in the high-risk classes (Class IIb or III, according to the HTA regulation article 7). Within these categories, only those which for with an expert panel opinion has been issued will be considered (1). This expert panel opinion can be issued for implantable Class III devices and Class IIb active devices for administration/removal of a medicinal product, as part of the conformity assessment carried out to obtain the CE marking (3). Therefore, one would expect that only this subset of devices will be considered.
According to Article 7 of the HTA Regulation, MDs from these groups will be chosen for JCA considering: “unmet medical needs”, “being first in class”, “the impact on patients, public health or health care systems”, “the incorporation of computer programs that use artificial intelligence, machine learning technologies or algorithms”, “an important cross-border dimension”, and “value added at the Union level” (1).
When Does it Start?
Although there is no specific date within the HTA Regulation for MDs, it is indicated that there will be JCAs at least every 2 years for MDs (Article 7) (1) and the Work Plan published in November 2024 indicates that: a) there will be one to three JSCs for MDs in 2025 (with a JSC application period from the 2nd to the 30th of June 2025), and b) JCAs for MDs will start in 2026 (4).
Who is Involved in the Evaluations?
A coordination group at European level (HTA CG) has been set up, which is responsible for organizing subgroups for consultations (JSC subgroup), assessments (JCA subgroup), identifying emerging health technologies (EHT subgroup), and developing methodological and procedural guidance (MPG subgroup). Subgroup components and the content of their meetings can be consulted on the European Commission’s website. Two countries have the co-presidency of each subgroup. They will work in parallel with other authorities such as Notified Bodies and Expert Panels.
A “Stakeholder network” has also been formed, including health professional organizations, health technology developers, and patient organizations among others. This network will be consulted by the different subgroups, to ensure that a voice is given not only to the regulatory bodies and competent authorities, but also to those who will be affected by the outcome of these evaluations.
Joint Scientific Consultation (JSC)
The JSC applies to those products that are likely to be subject to a JCA in the future. It focuses on the development plans to identify what elements will be necessary in a subsequent JCA, including the design of clinical investigations considering the comparators, interventions, the outcomes, and the type of patients to be included (Article 16 (1)).
On January 24, 2025, the JSC Implementing Regulation for MDs was published (5), with the details of the process:
- The application for the JSC will be submitted through the HTA’s IT platform. The manufacturer shall indicate whether a parallel consultation is also being carried out by the expert panel indicated in the European Medical Device Regulation (MDR, 3), to coordinate the activities of both evaluators. Within 15 days, the manufacturer will be notified of whether their MD has been selected for a JSC.
- The JSC coordination subgroup and the European Medicines Agency will be in contact to coordinate consultations of HTA stakeholders and MDR expert panels, and the transfer of information between them and the manufacturer.
- A meeting will be set up with all stakeholders (the manufacturer, JSC subgroup evaluators, the expert panel, and any relevant network members) to discuss the various aspects of the consultation, including a series of questions that will be communicated to the manufacturer in advance.
- At the end of the process, a report from the JSC will be sent to the manufacturer, which will include the HTA’s advice for the future JCA. This report will not be public, but a summarized and anonymized version will be included on the HTA’s website, as well as in its annual report.
Joint Clinical Assessment (JCA)
Although the JCA Implementing Regulation for MDs is still under preparation (expected in the second quarter of 2025, (6)), the HTA Regulation already has general information on the process.
The JCAs will evaluate parameters similar to those of the JSC, although it is not a requirement to have had a previous JSC for the medical device to have a JCA. Article 8 of the Regulation (1) It indicates that the patient population, interventions, comparators and outcomes will be evaluated, as well as certain characteristics that may be specific to each particular product.
A JCA report will be made public, which will contain the assessment of key questions for local health policymakers. It shall include an assessment of safety and performance, as well as the possible degree of uncertainty of the evidence. However, it will not include conclusions on the added clinical value or value judgments.
With the information from the JCA report, each Member State will draw its own conclusions about the clinical value added in the context of its health system and elaborate its national HTA.
What Lies Ahead
Several documents oriented to MDs are expected to be published during the year, including guidelines on the selection of MDs, guidelines on JSC and JCA procedures, and various templates for both manufacturers and HTA evaluators. For the time being, it is possible to follow the discussions from the HTA CG meetings. The last meeting took place in November 2024 and, as far as MDs are concerned, the opinion of several stakeholders was voiced out: hospitals emphasized the usefulness of clinical experts having access to the JCA before having the HTA at the local level, potentially accelerating decision-making. Notified Bodies discussed the differences between the requirements of the MDR and HTA Regulations, underlining the importance of the post-marketing clinical follow-up, and patient associations called for early involvement in the processes, highlighting the need for specific expertise and broader perspectives (7).
The convergence of MDR and HTA regulations in Europe marks a significant shift in medical device market access. Success in this new reimbursement environment requires early strategic integration of MDR and HTA requirements in the device development plan, as well as proactive engagement of NBs, EU commission expert panels, and HTA member groups.
References
- Reglamento (UE) 2021/2282 del Parlamento Europeo y del Consejo de 15 de diciembre de 2021 sobre evaluación de las tecnologías sanitarias y por el que se modifica la Directiva 2011/24/UE.
- HTA Guidance on the scoping process V1.0 13 November 2024.
- Reglamento (UE) 2017/745 del Parlamento Europeo y del Consejo de 5 de abril de 2017 sobre los productos sanitarios, por el que se modifican la Directiva 2001/83/CE, el Reglamento (CE) n.o 178/2002 y el Reglamento (CE) n.o 1223/2009 y por el que se derogan las Directivas 90/385/CEE y 93/42/CEE del Consejo.
- HTA Annual Work Programme 2025 V1.0 28 Noviembre 2024.
- Reglamento de ejecución (UE) 2025/117 de la Comisión de 24 de enero de 2025 por el que se establecen disposiciones de aplicación del Reglamento (UE) 2021/2282 en lo que respecta a los procedimientos para consultas científicas conjuntas sobre productos sanitarios y productos sanitarios para diagnóstico in vitro.
- Implementation Rolling Plan Regulation (EU) 2021/2282 on Health Technology Assessment. Última actualización: 10 enero 2025.
- Minutes – HTA Stakeholder Network 29 Noviembre 2024 [Internet]. Disponible en: https://health.ec.europa.eu/latest-updates/minutes-hta-stakeholder-network-29-november-2024-2025-02-04_en
