Publication selection

The records included in this review were sourced from organizational websites, databases, and grey literature. The search of organizational websites listed in Supplementary Table S2 resulted in the retrieval of 375 unique records. Of these, only 92 records were relevant and included in the study, and 283 records were excluded after full-text assessment (Figure 1).

For the database search, a total of 1,045 records were identified (details of search results are described in Supplementary Table S7), comprising 953 unique publications and 92 duplicates. A total of 819 publications were excluded based on the title and abstract screening, and the full texts of the remaining 134 records were assessed for eligibility, resulting in the inclusion of twenty-four publications in the study (Figure 1). The agreement rate between the first and second reviewers was approximately 98 percent, which was considered acceptable. The Medline Complete search was rerun on 20 January 2025, and three additional results were identified, which were excluded based on title and abstract screening. Finally, the grey literature search resulted in the inclusion of twelve records (Figure 1). References are cited in their respective location in the manuscript and Supplementary Materials.

A comprehensive summary of the information for each country was sent for external validation to national organizations in thirty-four countries. Feedback was received from thirty of thirty-four contacted countries (88 percent response rate, with England, Scotland, Wales, and Northern Ireland counted separately). The organizations that provided feedback or verified the information are listed in Supplementary Table S8. This validation process led to the inclusion of 11 additional records (publications, official website pages, and documents) provided by the external validators. As a result, a total of 139 records were incorporated into the study (Figure 1).

Implementation of Health Technology Assessment for the medical devices process across the EU/EEA/UK

This study examines the role of HTA in different reimbursement pathways of high-risk MD and IVD across the EU, the EEA, and the UK.

Specifically, the analysis includes all twenty-seven EU member states, Iceland, Liechtenstein, Norway, and the UK (Figure 2), totaling thirty-four countries (with England, Scotland, Northern Ireland, and Wales considered separately). The results show that HTA for high-risk MD/IVD is not established in all EU/EEA/UK countries. Of the thirty-four countries in this review, we identified publicly available information on the reimbursement process for high-risk MD/IVD in thirty-one countries; there was no detailed public information on MD/IVD reimbursement pathways for three countries (Luxembourg, Liechtenstein, and Iceland).

Figure 2.

Formal mechanisms to address evidence uncertainty in the reimbursement of high-risk MD/IVD across countries with any form of HTA for medical devices (as of November 2024). Countries are categorized according to the presence or absence of mechanisms to address the uncertainty of comparative safety and effectiveness evidence within the reimbursement frameworks. Only countries with reported forms of HTA for reimbursement of medical devices are described in this figure (n = 23 countries). The figure was created using mapchart.net.

Of the thirty-one countries with publicly available information, any form of HTA process for medical devices (including high-risk MD/IVD) was reported in the reimbursement decision-making process in twenty-three countries (Table 1). Eight countries confirmed the lack of an established HTA process for medical devices, and no information was found regarding HTA and reimbursement decision-making in the remaining three countries (Table 1). Due to information scarcity, countries without a reported HTA process for high-risk MD/VD (n = 8) and those without publicly available information on HTA processes (n = 3) are excluded from further analysis in this review.

Table 1.

Reported HTA processes for reimbursement decisions of medical devices across the EU/EEA/UK as of November 2024

^a The information for 30 countries (88 percent) was verified by national organizations listed in Supplementary Table S9.

Key oversight structures involved in decision-making on patient access to medical devices in the EU/EEA/UK

For the twenty-three countries with any form of HTA for medical devices, the process summary and oversight structures involved in assessment and reimbursement decision-making are detailed in Table 2. Furthermore, oversight structures involved in the initiation and prioritization of reimbursement requests are described in Supplementary Table S10. Generally, in these countries, the reimbursement process for high-risk MD/IVD is organized in a structured, stepwise approach with four main stages. The first stage is the topic identification, with or without a prioritization step (Supplementary Table S10). The second step is the assessment (i.e., HTA) stage, where the evidence of comparative safety and effectiveness of the device, among other factors, is assessed to generate an output (e.g., recommendation, advice, or conclusion) (Table 2). In this stage, there is considerable variability in how the assessment is done and how the evidence is considered. Some countries rely on evidence synthesis, appraisal of manufacturer submissions, or both. The specifics of the assessment stage are described in detail in a published European network for the HTA (EUnetHTA) report (22). Additionally, the scope of HTA varies across countries in terms of whether it is limited to comparative clinical effectiveness and safety or extends to other domains such as economic evaluation, organizational impact, and ethical considerations. These details are thoroughly described in Supplementary Table S11.

Table 2.

Overview of the oversight structures involved in the assessment and reimbursement of high-risk MD/IVD across the EU/EEA/UK as of November 2024

AIHTA: Austrian Institute for Health Technology Assessment. STA: Single Technology Assessment. MTA: Multiple Technology Assessment. CTIIMH-CRIDMI: The Commission of Reimbursement of Implants and Invasive Medical Devices. INAMI-RIZIV: National Institute for Health and Disability Insurance. KCE: Belgian Health Care Knowledge Centre. CTM: Medical Technical Council. CHIF: Croatian Health Insurance Fund. MoH: Ministry of Health. DHTC: Danish Health Technology Council. EHIF: Estonian Health Insurance Fund. FinCCHTA: Finnish Coordinating Center for Health Technology Assessment. COHERE Finland: Council for Choices in Health Care in Health Care in Finland. Kela: Social Insurance Institution of Finland. CNEDiMTS: Medical Device and Health Technology Evaluation Committee. HAS: French National Authority for Health. CEPS: Economic Committee for Health Products. CEESP: The Commission for Economic and Public Health Evaluation in France. HSE: Health Service Executive. InEK: Hospital Remuneration System. G-BA: Federal Joint Committee in Germany. IQWiG: The Institute for Quality and Efficiency in Healthcare. SHI: Statutory Health Insurance in Germany. FHC: Federal Healthcare Commission. NEAK: National Health Insurance Fund in Hungary. TéF: Technology Assessment Department in Hungary. NNGYK: National Centre for Public Health and Pharmacy in Hungary. HIQA: Health Information and Quality Authority. AGENAS: National Agency for Regional Healthcare Services. SSN: National Health Service in Italy. VASPVT: State Accreditation Service for Health Care Activities under the Ministry of Health of the Republic of Lithuania. VLK: National Health Insurance Fund in Lithuania. ZIN: the National Health Care Institute in the Netherlands. AOTMiT: Agency for Health Technology Assessment and Tarification. INFARMED: the National Authority for Medicaments and Health Products. CATS: The Portuguese Commission for Health Technology Assessment. NIHO: National Institute For Value And Technologies In Healthcare. MZSR: The Ministry of Health of the Slovak Republic. RedETS: Spanish Network of Health Technology Assessment Agencies. TLV: The Dental and Pharmaceutical Benefits Agency. MTP Council: Medical Technology Product Council in Sweden. NICE: National Institute for Health and Care Excellence (England). MTEP: Medical Technologies Evaluation Programme (England). DAP: Diagnostics Assessment Programme (England). EAG: External Assessment Group. HTW: Health Technology Wales. SHTG: Scottish Health Technologies Group. NHS: National Health Service (UK). NOMA: Norwegian Medical Products Agency (previously called the Norwegian Medicines Agency).

^a “Unclear” was used when some information was available but lacked sufficient detail to describe how prioritization occurs. “No information” was used when no relevant description of prioritization processes could be identified.

^b HTA in Croatia was performed by the Agency of Quality and Accreditation in Health Care (the Department for Development, Research, and HTA) from 2009 until 2018, before being taken over by the MoH on 01/01/2019.

^c The four regional health authorities (RHAs) are: Central Norway Regional Health Authority (“Helse Midt-Norge”); Northern Norway Regional Health Authority (“Helse Nord”); Southern and Eastern Norway Regional Health Authority (“Helse Sør-Øst”); and Western Norway Regional Health Authority (“Helse Vest”).

The third stage is the recommendation stage, where different outcomes are concluded based on the assessment stage. In some cases, the assessment does not include a formal recommendation; in other cases, a clear recommendation regarding device reimbursement is provided (Table 2). Finally, the fourth and final step is the reimbursement decision, where a decision is made regarding funding. Depending on the national context, this decision may be contingent on the outcome of the HTA assessment, may consider the output in the context of other financial or organizational aspects, or may be made independent of it.

Different stakeholders in each country can initiate the reimbursement process for MD and IV (described in detail in Supplementary Table S10). After proposal submission, a formal prioritization process before assessment was reported in at least eight countries. Then, selected technologies, with or without prioritization, proceed to the assessment stage (Supplementary Table S10). The HTA involves evaluating comparative safety and effectiveness, among other criteria unique to national requirements, as explained in the following section. Depending on the national context, these assessments may rely on an appraisal of manufacturer submissions, incorporate independent evidence synthesis, or combine both approaches.

All twenty-three countries have at least one centralized pathway for conducting HTA. In nineteen countries, assessments are carried out by independent bodies (e.g., CNEDiMTS of HAS in France and IQWiG in Germany). In one country, HTA is conducted directly by the Public Health Insurance body (Public Health Insurance in the Czech Republic). Additionally, three countries (Belgium, Croatia, and Estonia) have two organizations involved in the assessment of MD/IVD for reimbursement purposes. The first organization is primarily responsible for appraising manufacturer-submitted evidence to generate reimbursement recommendations; these are the National Institute for Health and Disability Insurance (RIZIV-INAMI) in Belgium, the Croatian Health Insurance Fund (CHIF) in Croatia, and the Estonian Health Insurance Fund (EHIF) in Estonia. The second organization generally provides an independent evidence synthesis, separate from manufacturer submissions, mainly when the submitted evidence is incomplete. These bodies include the Belgian Health Care Knowledge Centre (KCE) in Belgium, the Ministry of Health in Croatia, and the University of Tartu in Estonia (Table 2).

Generally, the assessment results include a scientific conclusion accompanied by a recommendation. In nineteen of twenty-three countries, the HTA recommendation is forwarded to a separate independent body (distinct from the HTA-performing organization) to develop a final decision or recommendations regarding the reimbursement of the MD/IVD. In contrast, in one country (the Czech Republic), the HTA recommendations are produced by the reimbursement decision-making body itself (the Public Health Insurance body), which directly determines the reimbursement outcomes. In three countries (Belgium, Croatia, and Estonia), both approaches coexist; HTA can either be performed by an independent body and then forwarded to the decision-making authority or be produced directly by the reimbursement decision-making body (RIZIV-INAMI in Belgium, CHIF in Croatia, and EHIF in Estonia). Finally, the conclusions and recommendations of HTA are used, among other factors, to inform the reimbursement of devices by public healthcare providers and public health insurance funders (Table 2).

Countries with no formal HTA processes for high-risk MD/IVD (Bulgaria, Cyprus, Malta, Latvia, Greece, Romania, Slovenia, and Northern Ireland) may rely on central or local procurement processes without significant contribution of HTA to decision-making. This suggests that the reimbursement decisions in these settings may be largely influenced by financial considerations; however, the determination of what informs these decisions was beyond the scope of this review.

The role of HTA in reimbursement pathways of high-risk MD/IVD

For the twenty-three countries with any form of HTA for high-risk MD/IVD in place, the level to which HTA is integrated into reimbursement frameworks and criteria for HTA assessment varies significantly. The data reflect considerable variability in the extent to which the HTA recommendations influence national reimbursement. The countries can be generally grouped into the following three main categories:

1. 1. Countries where HTA is a formal element of certain reimbursement pathways include Austria, Germany, France, Belgium, Norway, Hungary, Sweden (based on the Swedish Joint Cooperation Model for assessing and procuring medical technology), Spain, Lithuania, Portugal, and England.

2. 2. Countries where HTA is not a formal part of any reimbursement pathway (forms an optional/conditional element), include The Netherlands (open reimbursement system for MD/IVD, allowing reimbursement without ZIN assessment, with ZIN providing HTAs to address disputes between physicians, patients, and insurers regarding the inclusion of certain MD/IVD in health care packages (110))**, Croatia, Estonia, Slovakia, Ireland, Italy, Scotland, Wales.

3. 3. Countries where it is unclear if HTA is a formal part of reimbursement pathways include the Czech Republic, Denmark, Finland, and Poland.

Extended information for each of these countries is provided in Supplementary Table S11, which provides an overview of key national reimbursement mechanisms for high-risk MD/IVD, the role of HTA in each country’s reimbursement process, and factors considered in HTA recommendations and final decisions.

Mechanisms to address the uncertainty of comparative safety and effectiveness evidence for high-risk MD/IVD

For countries with reported HTA for MD/IVD, there is significant diversity in how each country manages uncertainty in relation to comparative safety and effectiveness evidence. Such uncertainty may originate from clinical, economic, or safety data gaps, which may be incomplete or inconclusive. A summary of how countries deal with evidence uncertainty is presented in Figure 2. The countries can be generally grouped into the following three main categories:

1. (1) Countries with an established formal mechanism for addressing evidence uncertainty (eight countries; Figure 2). For these countries, there is a dedicated reimbursement route in case of evidence uncertainty. The funding mechanisms, reimbursement conditions, and criteria in the context of uncertainty are summarized in Supplementary Table S12. The funding decisions, in this case, are often linked to specific criteria, the most common being the potential added clinical benefit of the device, disease severity, and the device’s ability to address unmet or partially met clinical needs in the national context. In these countries, the devices can be reimbursed under different conditions aimed at addressing this uncertainty, including managed access agreements, reimbursement exclusively in research conditions, initiating clinical trials, and coverage with evidence development.

2. (2) Countries with no formal mechanism to address evidence uncertainty (two countries; Figure 2).

3. (3) Countries with unclear processes or no information regarding the mechanisms for addressing uncertainty, which suggests the lack of a formal process (12 countries; Figure 2). This category also includes countries that might have a specific outcome for HTA in case of evidence uncertainty; however, no complementary mechanism for reimbursement has been identified.

Regional variations and the level of centralization in the reimbursement framework and decisions implementation

As previously mentioned, all the countries with any form of HTA for high-risk MD/IVD have at least one mechanism for national-level HTA assessment and generation of recommendations for these devices. However, the locus of authority and decision-making structures governing the reimbursement of high-risk MD/IVD vary significantly. This results in different levels of regional variabilities of medical device reimbursement. The level of centralization in the reimbursement frameworks for each country is summarized in Figure 3 and further described in detail in Supplementary Table S13.

Figure 3.

Centralization levels of reimbursement frameworks for MD/IVD across countries with any form of HTA for medical devices (as of November 2024). Countries are categorized according to the extent of national centralization of reimbursement frameworks. Only countries with reported forms of HTA for reimbursement of medical devices are described in this figure (n = 23 countries). The figure was created using mapchart.net.

Countries can be generally classified into two main categories. The first includes those countries with generally centralized reimbursement frameworks (12 countries), where the vast majority of reimbursement decisions occur at the national level, with an expected homogeneous reimbursement and implementation throughout the country (Figure 3).

The second category includes countries with mixed or generally decentralized reimbursement frameworks (six countries), where the majority of medical devices are being adopted through regional or hospital-level device uptake, with or without local assessment. While some countries within this category may have a national-level reimbursement scheme, it is typically secondary to regional or local hospital-level processes, resulting in more variability in how medical devices are adopted. Hospital-based HTA activities vary considerably but can include horizon scanning, early assessments, prioritization, and other related aspects of HTA. Regarding its role in hospital-level decision-making, recommendations from hospital-based HTA may be mandatory or optional. (Reference Di Bidino, Lipska and Kukla107)

Some of these countries might have limited integration of HTA overall in the reimbursement decisions of high-risk MD/IVD. This category also includes countries with mixed systems, where centralized HTA takes place at the national level; however, reimbursement decisions are still made at the regional or local level. In these cases, national HTA recommendations might provide advice for local decisions, but regional authorities are ultimately responsible for decision-making. No information was found regarding the status of centralization in the three countries (Ireland, Slovakia, and the Czech Republic; Figure 3).