LegalizeCommission Implementing Regulation (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| 1. | Overview | |
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| 1.1. | Information about the medical device under assessment (‘the medical device’) and the HTD This section shall provide: (a) the trade name of the medical device; (b) the corporate name and permanent address of the HTD submitting the dossier for the JCA. In case the manufacturer to which the certificate of conformity for the medical device was issued is different from the HTD submitting the dossier, the corporate name and address of both the manufacturer and the HTD shall be specified. | |
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| 1.2. | Previous assessments under Regulation (EU) 2021/2282 (point e of Annex II.1 to Regulation (EU) 2021/2282) This section shall indicate whether the medical device has been subject to a previous assessment under Regulation (EU) 2021/2282, either for the same medical indication or for another medical indication. If the answer is positive, the section shall provide the medical indication, the date and the reference of the previous JCA report. | |
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| 1.3. | Executive summary (points j to m of Annex II.1 to Regulation (EU) 2021/2282) This section shall provide a concise executive summary of the dossier focusing on the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282 and shared with the HTD in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282 (‘the assessment scope’). The executive summary shall include: (a) the identification of any PICO(s) for which data was not submitted; (b) a summary of the data analysed (e.g. effect measures with statistical precision for each outcome) with regard to the assessment scope, indicating whether the results were based on direct or indirect evidence. The data shall be provided for each PICO separately; (c) the degree of certainty with regard to the PICO(s). | |
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| 2. | Background | |
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| 2.1. | Characterisation of the medical condition to be treated, prevented or diagnosed (point h of Annex II.1 to Regulation (EU) 2021/2282) | |
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| 2.1.1. | Overview of the medical condition This section shall: (a) describe the medical condition which the medical device intends to treat, monitor, alleviate, compensate, prevent or diagnose, including criteria for its diagnosis, if available, using a standardised code such as the International Statistical Classification of Diseases and Related Health Problems (‘ICD’) code or the Diagnostic and Statistical Manual of Mental Disorders (‘DSM’) code and the version of the code; (b) where relevant, describe the main stages and/or subtypes of the medical condition; (c) include any prognostic factors that may affect the course of the disease or medical condition and the prognosis of the medical condition without the new treatment; (d) present an estimate of the most recent prevalence and/or incidence for the medical condition in the EEA States and, where relevant, describe any profound differences between these EEA States; (e) describe the symptoms and burden of the medical condition for patients, including aspects such as pain, disability, psychosocial issues, and other determinants of morbidity and quality of life from a patient’s perspective; (f) for medical conditions that result in disability and/or a need for a family caregiver, and for treatments that result in major organisational changes to the healthcare system (e.g., due to manufacturing constraints) or major associated procedures: briefly describe the organisational and societal impact of the medical condition and its treatment, giving some context for interpretation of outcomes. References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1. | |
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| 2.1.2. | Characterisation of the target patient population In case the target population is more specific than the overall medical condition, this section shall: (a) name and describe the default target patient population(s) for the indication(s), in line with the intended purpose specified in the product certificate and summary of safety and clinical performance of the device (where relevant); (b) describe and justify the proposed position of the target patient population(s) in the patient pathway of care; (c) where relevant, take into account sex, age and other specific characteristics; (d) describe any patient sub-populations, including the criteria for their identification, if specifically defined in the assessment scope, and further patient sub-populations, if appropriate; (e) describe the natural progression of the medical condition (by patient sub-population, if appropriate). References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1. | |
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| 2.1.3. | Clinical management of the medical condition This section shall: (a) describe the care pathway for the medical condition, which the medical device intends to treat, monitor, alleviate, compensate, prevent or diagnose where relevant, for different stages and/or subtypes of the disease or medical condition or patient sub-populations, with diagrams of the care pathway(s) that include comparator(s); (b) where care pathways vary substantially between the EEA States, briefly describe these variations in care; (c) include a list of relevant clinical guidelines at the European level, e.g., by European medical associations or societies, if available. References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1. | |
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| 2.2. | Characterisation of the medical device (point i of Annex II.1 to Regulation (EU) 2021/2282) | |
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| 2.2.1. | Characteristics of the medical device This section shall describe the characteristics of the medical device and in particular, report the following information: (a) model(s) of the medical device including description of the different references / reference number(s) / software version; (b) Basic UDI-DI(s) referred to in the current certificate of conformity; (c) risk class of the medical device; (d) European Nomenclature on Medical Devices (EMDN) 10 description (most granular level, as relevant); (e) intended purpose; (f) brief description of the medical device including its constituents; (g) mode(s) of action; (h) frequency and duration of use; (i) claimed device lifetime; (j) when previous versions of the medical device are available, description of the main changes made to these different versions; (k) if applicable, specific description for the connected technology; (l) for medical devices with an embedded decision-making system based on machine learning and artificial intelligence processes, description of the functions built-in or evolving using these technologies. References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1. | |
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| 2.2.2. | Summary of the main requirements for use This section shall: (a) describe procedures including surgical procedures, and services associated with the use of the medical device; (b) describe organisational aspects associated with the use of the medical device, in particular any specifically qualified personnel, training of users, specific equipment and special facilities required to use the medical device, including any specific tests or investigations required. Where such equipment has been fully described in Section 2.2.1, the current section shall refer to the above description and state that there are no additional requirements; (c) describe any additional supplies (except generic supplies) required to use the medical device, where applicable. These characteristics shall be specified by sub-population, if appropriate. References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1. | |
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| 2.2.3. | Regulatory status of the medical device This section shall: (a) provide the regulatory status of the medical device in the indication considered for this JCA in Australia, Canada, China, Japan, United Kingdom, United States of America and other countries if relevant; (b) indicate the date on which the medical device was placed on the EU market, where applicable; (c) detail ongoing or planned early access/compassionate use programs in the EEA States; (d) specify if the medical device has been certified under Regulation (EU) 2017/745 for other indications than the indication considered for this JCA. References for the statements shall be provided. Full texts of references shall be provided in Appendix D.1. | |
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| 2.3. | JSC related to the JCA (point g of Annex II.1 to Regulation (EU) 2021/2282) Where the medical device has been subject to a JSC under of Regulation (EU) 2021/2282, this section shall explain any deviation from the recommended proposition for evidence generation. The recommendations shall be documented in Appendix D.8. | |
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| 3. | Assessment scope (point j of Annex II.1 to Regulation (EU) 2021/2282) This section shall: — reproduce the assessment scope in the format shared with the HTD in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282; — clearly identify any PICO(s), for which data is not submitted and explain the reasons for this omission. | |
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| 4. | Description of methods used in the development of the content of the dossier (point k of Annex II.1 to Regulation (EU) 2021/2282) This section shall describe the methods used in the development of the content of the dossier. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282. | |
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| 4.1. | Criteria for selecting studies for JCA This section shall specify the inclusion and exclusion criteria for studies to be considered for this JCA based on the assessment scope. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282. The specification for inclusion and exclusion criteria shall be provided for each PICO, as appropriate. | |
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| 4.2. | Information retrieval and selection of relevant studies | |
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| 4.2.1. | Information retrieval The HTD shall explain the conduct of the information retrieval process with the objective of identifying the evidence to be used for the preparation of the dossier, systematically considering the following sources of information: (a) clinical efficacy and safety studies and where relevant, other applicable studies conducted or sponsored by the HTD or by third parties, including ongoing studies, in order to include all up-to-date published and unpublished information (data, analyses and any other evidence) from studies on the medical device for which the HTD was a sponsor and corresponding information about studies by third parties, if available; (b) bibliographic databases, including at least the National Library of Medicine's bibliographic database (MEDLINE) and the Cochrane Central Register of Controlled Trials database; (c) study registries and study results registries (clinical trial databases); (d) HTA reports on the medical device subject to the JCA from the EEA States and from Australia, Canada, the United Kingdom and the United States of America; (e) clinical evaluation report (CER); (f) medical device and patient registries. This section shall: (a) provide a list of the sources that were systematically searched for studies that are relevant for the JCA according to the assessment scope and indicate the date of each search, with a cut-off date for the searches of a maximum of 3 months before the submission of the dossier; (b) report whether and when new data with relevance for the assessment scope might become available. All search strategies shall be fully documented in Appendix D.2. | |
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| 4.2.2. | Selection of relevant studies This section shall document the approach for the selection of relevant studies from the results of the information retrieval according to inclusion and exclusion criteria defined in Section 4.1. That specification shall be provided for each PICO, as appropriate. The HTD shall consult the selection process suggested in the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282. | |
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| 4.3. | Methods for data analysis and synthesis This section shall describe the methods used for data analysis and synthesis following international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance. The underlying documentation for any analysis, i.e. study protocols and statistical analysis plans (including for evidence syntheses) and details on all software used, as well as the respective program code and relevant output shall be provided in the relevant parts of Appendix D. This section shall cover the following methodological aspects in the following respective sub-sections, where relevant: | |
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| 4.3.1. | Description of the design and methodology of the included original clinical studies | |
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| 4.3.2. | Direct comparisons by pairwise meta-analyses The protocol for evidence syntheses, including the relevant statistical analysis plan, shall be provided in Appendix D.5. | |
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| 4.3.3. | Indirect comparisons The protocol for evidence syntheses, including the relevant statistical analysis plan, shall be provided in Appendix D.5. | |
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| 4.3.4. | Sensitivity analyses This section shall describe and justify the methods of all performed sensitivity analyses. It shall describe the purpose or which methodological parameter the sensitivity analysis addresses, as well as underlying assumptions. | |
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| 4.3.5. | Subgroup analyses and other effect modifiers | |
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| 4.3.6. | Specification of further methods as required This section shall describe any other methods used in deriving results used in the dossier. | |
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| 5. | Results (point l of Annex II.1 to Regulation (EU) 2021/2282) The results presented in the dossier shall follow international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance. The presentation of results shall use text, figures and tables as appropriate. | |
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| 5.1. | Results from the information retrieval process Results from the different steps of the information retrieval process shall be presented transparently. For each study, the following information shall be indicated: the study reference ID, the study status, the study duration with data cut-off if applicable, and study arms. For each of the information retrieval steps, the studies not considered in the dossier shall be identified and listed. For each of them, the reason for exclusion shall be specified. The presentation of the results shall include in the following respective sub-sections: | |
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| 5.1.1. | List of studies conducted or sponsored by the HTD or by third parties This section shall report information on all the studies, including ongoing studies, conducted or sponsored by the HTD and third parties, referred to in point d of Annex II.1 to Regulation (EU) 2021/2282, including all studies providing clinical safety and clinical performance data from the CER. The listing shall be restricted to studies involving patients in the medical indication for which the dossier is prepared. The section shall also report whether and when new data with relevance for the assessment scope might become available during or after the assessment period. | |
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| 5.1.2. | Studies identified in searches of bibliographic databases This section shall present results from searches for studies on the medical device and its comparator(s) where relevant (e.g. for indirect meta-analyses) in bibliographic databases. | |
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| 5.1.3. | Studies in study registries and study results registries (clinical trial databases) In accordance with point f of Annex II.1 to Regulation (EU) 2021/2282, this section shall present results from searches for studies for the medical devices and its comparator(s) where relevant in study registries/study results registries. | |
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| 5.1.4. | HTA reports In accordance with point e of Annex II.1 to Regulation (EU) 2021/2282, this section shall list HTA reports available on the medical device subject to the JCA from the EEA States and from Australia, Canada, the United Kingdom and the United States of America. The HTA reports shall be provided in Appendix D.6. Any additional relevant evidence identified in those HTA reports which were not identified in other sources shall be listed. | |
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| 5.1.5. | Studies from the CER This section shall list all clinical performance and safety studies and where relevant, other applicable studies that were included in the CER. If the main studies do not address any of the PICO(s), they shall be presented in Appendix C and be provided in Appendix D.10. | |
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| 5.1.6. | Studies from medical device and patient registries This section shall present results from searches for studies for the medical device and its comparator(s), where relevant, in medical device and patient registries. | |
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| 5.1.7. | List of included studies overall and by PICO This section shall define the list of studies included in the dossier informing each PICO. If no evidence is available for a specific PICO question in the assessment scope, this shall be clearly reported in the dossier (‘No evidence provided by the HTD’) and duly justified. | |
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| 5.2. | Characteristics of included studies In accordance with point m of Annex II.1 to Regulation (EU) 2021/2282, this section shall provide an overview in tabular format of the study design and the study population for all studies included in the dossier to address any of the PICO(s). Information shall specifically be provided on: (a) the study type and design; (b) the study date and duration; (c) enrolled study population including key eligibility criteria and locations; (d) characteristics of the intervention and comparator(s); (e) study outcomes; (f) if applicable, data cut-off; (g) sample size; (h) analysis methods. The study interventions shall be characterised and information on the course of the study (i.e., planned and actual follow-up times per outcome) shall be provided. The studies included in the dossier shall be described briefly. A detailed description of the study methodology shall be provided in Appendix A. | |
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| 5.3. | Data analysis In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall present the data analysed to address each research question of the assessment scope. The data shall be presented by PICO. The presentation shall follow international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group under Article 3(7), point (d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance. This section shall also provide all information that is required to assess the degree of certainty with regard to the PICO(s), taking into account the strengths and limitations of the available evidence, including, but not limited to, the risk of biases. Details shall be provided in the relevant Appendixes. | |
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| 6. | List of references |
Appendixes
| Appendix A. | Tabular listing and information on methods of all studies included in the JCA The appendix shall include a listing of all studies included in the dossier informing each of the PICO(s) in the assessment scope. In addition, information on study methods and a patient flow chart shall be provided for each of the listed studies. | |
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| Appendix B. | Information to assess the degree of certainty with regard to the PICO(s) (including, but not limited to, the risk of biases) | |
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| Appendix C. | Results of the main study/studies from the clinical development programme of the medical device (if not included in the presentation by PICO question(s)) | |
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| Appendix D. | Underlying documentation | |
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| D.1. | Full texts of references | |
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| D.2. | Documentation of information retrieval | |
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| D.2.1. | Documentation of search strategies for each information source | |
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| D.2.2. | Results of the information retrieval in standard format | |
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| D.3. | Programming code for programs used for analyses This appendix shall provide program code and relevant output if the analyses and corresponding calculations cannot be described by a specific standard method. | |
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| D.4. | Study reports for original clinical studies This appendix shall provide clinical study reports, clinical study protocols and statistical analysis plans, referred to in point d of Annex II.1 to Regulation (EU) 2021/2282. | |
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| D.5. | Study reports for evidence synthesis studies This appendix shall provide all up-to-date published and unpublished information and data-analyses, including study protocols and statistical analysis plans, referred to in point d of Annex II.1 to Regulation (EU) 2021/2282 which are required for evidence synthesis studies. For each study, the clinical study report shall be provided only once. | |
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| D.6. | HTA reports of the medical device subject to the JCA (where appropriate) | |
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| D.7. | Information on data from registries and studies based on registries This appendix shall include data and studies with the medical device from patient registries, if available. | |
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| D.8. | Information on JSCs (where appropriate) | |
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| D.9. | Clinical evaluation assessment report (CEAR) | |
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| D.10. | Clinical evaluation report (CER) and its updates (where available) referred to in Article 61(12) of Regulation (EU) 2017/745 and Part A of Annex XIV to Regulation (EU) 2017/745 | |
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| D.11. | Clinical evaluation plan (CEP) referred to in Part A of Annex XIV to Regulation (EU) 2017/745 | |
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| D.12. | PMCF plan and PMCF evaluation report (where available) referred to in Part B of Annex XIV to Regulation (EU) 2017/745 or a justification why a PMCF is not applicable | |
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| D.13. | Opinion of the expert panels provided in the framework of the clinical evaluation consultation procedure |
ANNEX II
TEMPLATE FOR THE DOSSIER FOR THE JOINT CLINICAL ASSESSMENT OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE
The provision of information, data, analysis and other evidence in the dossier shall follow international standards of evidence-based medicine. The health technology developer shall consult, if available, the methodological guidance adopted by the Member State Coordination Group on Health Technology Assessment (‘the Coordination Group’) under Article 3(7), point (d), of Regulation (EU) 2021/2282 where applicable and describe and justify any deviations from that guidance. The information requested in the dossier template shall be provided in a clear format, preferably in tabular format when possible.
Revision history
Unnecessary lines shall be deleted. If needed, lines may be added.
| Version | Document | Legal reference | Submission date | Commission’s check date |
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| V0.1 | Initial dossier | Article 10(2) of Regulation (EU) 2021/2282 | ||
| V0.2 | (Updated dossier following Commission’s second request) | Article 10(5) of Regulation (EU) 2021/2282 | ||
| V0.3 | (Updated dossier following assessors’ request for further specifications, clarifications or additional information) | Article 11(2) of Regulation (EU) 2021/2282 | N/A | |
| V0.4 | (Updated dossier following re-initiation of a JCA) | Article 10(8) of Regulation (EU) 2021/2282 | N/A | |
| V0.5 | (Dossier with the HTD’s indications and justification of confidential information) | Article 11(5) of Regulation (EU) 2021/2282 | N/A | |
| V1.0 | Dossier for publication (without confidential information) | Article 21 of Implementing Regulation (EU) 2025/2086 | N/A | |
| V1.0.1 | (Updated dossier where the joint clinical assessment report specifies the need for an update and additional evidence for further assessment becomes available) | Article 19(1) of Implementing Regulation (EU) 2025/2086 | N/A | |
| V1.0.2 | (Updated dossier provided on the initiative of the HTD where additional evidence for further assessment becomes available) | Article 19(2) of Implementing Regulation (EU) 2025/2086 | N/A | |
| V1.0.3 | (Updated dossier following the initiation of an update of a JCA – update of the assessment scope not needed) | Article 19(5) of Implementing Regulation (EU) 2025/2086 | ||
| V1.0.4 | (Updated dossier following the initiation of an update of a JCA – update of the assessment scope needed) | Article 19(6) of Implementing Regulation (EU) 2025/2086 | ||
| V1.0.5 | (Updated dossier following the initiation of an update of a JCA with the HTD’s indications and justification of confidential information) | Article 11(5) of Regulation (EU) 2021/2282 | N/A | |
| V2.0 | (Dossier for publication following the finalisation of an update of a JCA (without confidential information)) | Article 21 of Implementing Regulation (EU) 2025/2086 | N/A |
List of abbreviations
The following list presents suggestions for abbreviations. It may be adapted to the dossier. Supplementary lines may be added, if needed.
| Abbreviation | Meaning |
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| EEA | European Economic Area |
| HTA | Health Technology Assessment |
| HTD | Health Technology Developer |
| IVD | In vitro Diagnostic Medical Device |
| JCA | Joint Clinical Assessment |
| JSC | Joint Scientific Consultation |
| PCR | Polymerase Chain Reaction |
| PER | Performance evaluation report referred to in Article 56(6) of Regulation (EU) 2017/746 and Section 1.3 of Annex XIII to Regulation (EU) 2017/746 |
| PICO | A set of parameters for the joint clinical assessment in terms of: Patient Population – Intervention(s) – Comparator(s) – Health Outcomes |
Table of Contents
List of tables
| 1. | Overview | |
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| 1.1. | Information about the in vitro diagnostic medical device under assessment (‘the IVD’) and the HTD This section shall provide: (a) the trade name of the IVD; (b) the corporate name and permanent address of the HTD submitting the dossier for the JCA. In case the manufacturer to which the certificate of conformity for the IVD was issued is different from the HTD submitting the dossier, the corporate name and address of both the manufacturer and the HTD shall be specified. | |
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| 1.2. | Executive summary This section shall provide a concise executive summary of the dossier focusing on the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282 and shared with the HTD in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282 (‘the assessment scope’). The executive summary shall include: (a) a summary of the data analysed with regard to the assessment scope. The data shall be provided for each PICO separately; (b) the degree of certainty with regard to the PICO(s). | |
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| 2. | Background | |
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| 2.1. | Characterisation of the target patient population This section shall name and describe the target patient population(s) for the indication(s) under assessment, in line with the intended purpose of the IVD as described in the PER. References for the statements shall be provided. | |
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| 2.2. | Characterisation of the IVD This section shall describe the characteristics of the IVD including the following information, where available in the PER, the clinical performance study plan (CPSP) or clinical performance study report: (a) model(s) of the IVD including description of the different references / reference number(s) / software version; (b) European Nomenclature on Medical Devices (EMDN) 11 description (most granular level, as relevant); (c) brief description of the device including its components in case the IVD is a kit; (d) specification of the analyte or marker to be determined by the IVD (e.g. SARS- CoV-2 spike protein, Kel1 (K)); (e) principle of the assay method or principles of operation of the instrument (e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.); (f) whether it is automated or not; (g) whether it is qualitative, semi-quantitative or quantitative; (h) type of specimen(s) required (e.g. whole blood, serum, saliva etc.); (i) intended user (e.g. self-testing, near patient and laboratory professional use, healthcare professionals); (j) instructions for use, necessary training and experience of the user, appropriate calibration procedures and means of control, indication of any other devices, medical devices, medicinal product or other articles to be included or excluded. References for the statements shall be provided. | |
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| 3. | Description of methods used in the development of the content of the dossier In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall describe the methods used in the development of the content of the dossier ensuring that the submitted evidence is complete and that the available data is appropriately analysed to answer the research questions of the assessment scope. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282. | |
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| 3.1. | Criteria for selecting studies for JCA This section shall specify the inclusion and exclusion criteria for studies to be considered for this JCA based on the assessment scope. The specification for inclusion and exclusion criteria shall be provided for each PICO, as appropriate. | |
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| 3.2. | Selection of relevant studies The HTD shall use the literature search report included in the PER with the objective of identifying the evidence to be used for the preparation of the JCA dossier. The HTD shall document the approach for the selection of relevant studies to address the assessment scope according to inclusion and exclusion criteria defined in Section 3.1. To develop its selection process, the HTD shall consult, if available, the methodological guidance adopted by the Coordination Group pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282. | |
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| 4. | Results | |
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| 4.1. | Results from the selection process In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall transparently present results from the selection process. All available studies shall be clearly identified using e.g. the study reference ID, the study status, the study duration, and study arms. Studies not considered in the dossier shall be listed with, for each of them, the reason for exclusion. The presentation of the results shall provide the list of studies included in the dossier, informing each PICO. If no evidence is available from the PER for a specific PICO question of the assessment scope, this shall be clearly reported in the dossier (“No evidence provided by the HTD”) and justified. | |
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| 4.2. | Characteristics of included studies In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall provide an overview in tabular format of all studies included in the dossier to address any of the PICO(s). Depending on the information available in the PER and CPSP, information shall be provided on: (a) the study type and design; (b) the study date and duration; (c) enrolled study population including key eligibility criteria and locations; (d) characteristics of the intervention, and comparator(s); (e) study outcomes; (f) if applicable, data cut-off; (g) sample size; (h) analysis methods. The studies included in the dossier shall be described briefly depending on the information available in the PER and CPSP. A detailed description of the study methodology shall be provided in Appendix A. | |
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| 4.3. | Data analysis In accordance with Articles 9(2) and (3) of Regulation (EU) 2021/2282, this section shall present the data analysed to address the research questions of the assessment scope. The presentation shall follow international standards of evidence-based medicine. The HTD shall consult, if available, the methodological guidance adopted by the Coordination Group under Article 3(7), point (d), of Regulation (EU) 2021/2282 and describe and justify any deviations from that guidance. This section shall also provide all information that is needed to assess the degree of certainty with regard to the PICO(s), as available from the PER or CPSP. | |
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| 5. | List of references |
Appendixes
| Appendix A. | Tabular listing and information on methods of all studies included in the JCA The appendix shall include a listing of all studies included in the dossier to address the research question. | |
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| Appendix B. | Information to assess the degree of certainty with regard to PICO(s) | |
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| Appendix C. | Underlying documentation | |
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| C.1. | Results of the selection process | |
| --- | --- | --- |
| C.2. | Performance evaluation report (PER), including the scientific validity report, the analytical performance report and the clinical performance report, together with an assessment of those reports, as referred to in Section 1.3.2 of Annex XIII to Regulation (EU) 2017/746 | |
| --- | --- | --- |
| C.3. | Clinical performance study plan(s) (CPSP) and clinical performance study report(s) referred to in Sections 2.3.2 and 2.3.3 of Annex XIII to Regulation (EU) 2017/746 | |
| --- | --- | --- |
| C.4. | Views of the expert panel provided in the framework of the performance evaluation consultation procedure | |
| --- | --- | --- |
| C.5. | Report of the European Union reference laboratory |
ANNEX III
TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT REPORT OF A MEDICAL DEVICE
The provision of information, data, analysis and other evidence in the report shall follow international standards of evidence-based medicine. The information shall be provided in a clear format, preferably in tabular format when possible.
List of abbreviations
The following list presents suggestions for abbreviations. It may be adapted to the report. Supplementary lines may be added, if needed.
| Abbreviation | Meaning |
|---|---|
| CER | Clinical evaluation report referred to in Article 61(12) and Section 4 of Annex XIV to Regulation (EU) 2017/745 |
| CIP | Clinical investigation plan referred to in Section 3, Chapter II, of Annex XV to Regulation (EU) 2017/745 |
| CIR | Clinical investigation report referred to in Section 7, Chapter III of Annex XV to Regulation (EU) 2017/745 |
| EEA | European Economic Area |
| HTA | Health Technology Assessment |
| HTD | Health Technology Developer |
| JCA | Joint Clinical Assessment |
| JSC | Joint Scientific Consultation |
| MD | Medical Device |
| PMCF | Post-Market Clinical Follow-up |
| PICO | A set of parameters for the joint clinical assessment in terms of: Patient Population – Intervention(s) – Comparator(s) – Health Outcomes |
| RCT | Randomised Controlled Trial |
Table of Contents
List of tables
| 1. | General information on the JCA This section shall provide: (a) information on the assessor and co-assessor; (b) an overview of the procedural steps and their dates; (c) information on the involvement of patients, clinical experts and other relevant experts, as well as on the input received from patient organisations, healthcare professional organisations and clinical and learned societies. The input from experts and stakeholders shall be provided in Appendix A; (d) information on previous JCA under of Regulation (EU) 2021/2282 (same indication or new indication) where relevant; (e) information on previous JSC under Regulation (EU) 2021/2282 where relevant. | |
| --- | --- | --- |
| 2. | Background | |
| --- | --- | --- |
| 2.1. | Overview of the medical condition This section shall provide: (a) a summary of the medical condition, including the symptoms and the burden and natural progression of the medical condition, its prevalence or incidence in the EEA States, as available; (b) a brief description of the target patient population and its characteristics reflected in the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282; (c) a brief description of the care pathway for the medical condition and whether it varies substantially between the EEA States, as well as, if relevant, for different stages and/or subtypes or sub-populations of the medical condition. | |
| --- | --- | --- |
| 2.2. | Characterisation of the medical device | |
| --- | --- | --- |
| 2.2.1. | Characteristics of the medical device This section shall describe characteristics of the medical device under assessment (‘the medical device’) and report the following information: (a) manufacturer (as mentioned on the certificate of conformity) and HTD submitting the JCA dossier if different from the manufacturer; (b) medical device trade name; (c) model(s) of the device / reference number(s) / software version; (d) Basic UDI-DI(s) referred to in the current certificate; (e) risk class of the medical device; (f) European Nomenclature on Medical Devices (EMDN) 12 description (most granular level, as relevant); (g) intended purpose; (h) brief description of the medical device including its constituents; (i) mode(s) of action; (j) frequency and duration of use, if applicable; (k) claimed medical device lifetime. (l) when previous versions of the medical device are available, description of the main changes made to these different versions; (m) if applicable, specific description for the connected technology; (n) for medical devices with an embedded decision-making system based on machine learning and artificial intelligence processes, description of the functions built-in or evolving using these technologies. | |
| --- | --- | --- |
| 2.2.2. | Summary of main requirements for use This section shall include a description of the procedures and services, as well as main organisational aspects associated with the use of the medical device. | |
| --- | --- | --- |
| 2.2.3. | Regulatory status of the medical device This section shall describe the regulatory information on the medical device. It shall also provide details of ongoing or planned early access/compassionate use programs in the EEA States. | |
| --- | --- | --- |
| 3. | Assessment scope This section shall reproduce the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282. | |
| --- | --- | --- |
| 4. | Results The results presented in this section shall follow international standards of evidence-based medicine. | |
| --- | --- | --- |
| 4.1. | Information retrieval This section shall include: (a) a description of the information retrieval performed by the HTD; (b) an assessment of the appropriateness of the sources and the search strategies of the HTD. It shall provide the date of the list of the studies, conducted or sponsored by the HTD or by third parties, referred to in point d of Annex II.1 to Regulation (EU) 2021/2282, as well as the date of the last searches for the medical device and the comparator(s) in bibliographic databases and in study registries and study results registries (clinical trial databases). Detailed information shall be provided in Appendix B. | |
| --- | --- | --- |
| 4.1.1. | Resulting list of included studies overall and by PICO This section shall provide in tabular format: (a) an overview of all included studies and the associated references for these studies overall and by PICO; (b) the list of studies included by the HTD which were excluded within the assessment, with a justification for their exclusion. | |
| --- | --- | --- |
| 4.2. | Characteristics of included studies | |
| --- | --- | --- |
| 4.2.1. | Included studies This section shall provide for the studies included in the assessment: (a) information on the study design (e.g., on randomisation, blinding, or parallel observation studies, and the key inclusion and exclusion criteria); (b) information on enrolled study populations (e.g., diagnosis, general severity of medical condition, and line of therapy); (c) characteristics of the study interventions; (d) information on the course of the study (e.g., planned and actual follow-up times per outcome); (e) information on the study duration. | |
| --- | --- | --- |
| 4.2.2. | Degree of certainty with regard to the PICO(s) This section shall describe the assessment of degree of certainty with regard to the PICO(s). | |
| --- | --- | --- |
| 4.3. | Study results on relative effectiveness and relative safety The results on relative effectiveness and relative safety shall be presented according to the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282, per PICO. | |
| --- | --- | --- |
| 4.3.1. | Results for patient population This section shall discuss to which extent the included patient populations and/or comparator(s) per study cover the relevant patient population/comparator(s) according to the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282. A separate section shall be provided for each patient population specified in the PICO(s). Within this section, the results for all PICO(s) addressing this patient population shall be presented in the following sub-sections. | |
| --- | --- | --- |
| 4.3.1.1. | Patient characteristics This section shall present patient characteristics from all studies covering the relevant patient population included in any of PICO(s) addressing this patient population. | |
| --- | --- | --- |
| 4.3.1.2. | Evidence synthesis methods This section shall briefly describe, when applicable, the evidence synthesis methods used by the HTD, including the associated strengths and limitations, and any factors arising from these methods and their application which may affect the certainty of the evidence. | |
| --- | --- | --- |
| 4.3.1.3. | Health outcome results for PICO <1> and uncertainties in the results Within the given patient population , results on health outcomes describing relative effectiveness and relative safety shall be described by PICO. The sub-section shall start by describing and justifying the choice of evidence (type of comparison) submitted to address the given PICO <1>. The sub-section shall present an overview of the available outcomes requested in the assessment scope per study. Results on relative effectiveness and relative safety (i.e., the relative effects of the medical device versus the comparator) shall include the results from all individual studies, as well as any quantitative syntheses of results, e.g., from meta-analyses. The results of the analyses of each of the presented outcomes shall be described briefly. The description shall address any issues affecting the degree of uncertainty of the relative effects. For each additional PICO question related to the given patient population , a new sub-section shall be created to present the results in terms of health outcomes for this PICO question. | |
| --- | --- | --- |
| 4.3.2. | Results of the main study from the clinical development programme of the medical device (if not addressed by any of PICO(s)) | |
| --- | --- | --- |
| 4.3.2.1. | Characteristics of the study | |
| --- | --- | --- |
| 4.3.2.2. | Patient characteristics | |
| --- | --- | --- |
| 4.3.2.3. | Health outcome results of the study and uncertainties in the results | |
| --- | --- | --- |
| 5. | References |
Appendixes
| Appendix A. | Input from experts and stakeholders | |
| --- | --- | --- |
| Appendix B. | Assessment of information retrieval | |
| --- | --- | --- |
| Appendix C. | Additional study information and data, including uncertainties in the results |
ANNEX IV
TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT REPORT OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE
The provision of information, data, analysis and other evidence in the report shall follow international standards of evidence-based medicine. The information shall be provided in a clear format, preferably in tabular format when possible.
List of abbreviations
The following list presents suggestions for abbreviations. It may be adapted to the report. Supplementary lines may be added, if needed.
| Abbreviation | Meaning |
|---|---|
| CPR | Clinical performance report referred to in Section 1.3.2 of Annex XIII to Regulation (EU) 2017/746 |
| EEA | European Economic Area |
| HTA | Health Technology Assessment |
| HTD | Health Technology Developer |
| IVD | In vitro Diagnostic Medical Device |
| JCA | Joint Clinical Assessment |
| JSC | Joint Scientific Consultation |
| PER | Performance evaluation report referred to in Article 56(6) of Regulation (EU) 2017/746 and Section 1.3 of Annex XIII to Regulation (EU) 2017/746 |
| PMCF | Post-Market Clinical Follow-up |
| PICO | A set of parameters for the joint clinical assessment in terms of: Patient Population – Intervention(s) – Comparator(s) – Health Outcomes |
| RCT | Randomised Controlled Trial |
Table of Contents
List of tables
| 1. | General information on the JCA This section shall provide: (a) information on the assessor and co-assessor; (b) an overview of the procedural steps and their dates; (c) information on the involvement of patients, clinical experts and other relevant experts, as well as on the input received from patient organisations, healthcare professional organisations and clinical and learned societies. The input from experts and stakeholders shall be provided in Appendix A; (d) information on previous JCA under Regulation (EU) 2021/2282 (same indication or new indication) where relevant; (e) information on previous JSC under Regulation (EU) 2021/2282 where relevant. | |
| --- | --- | --- |
| 2. | Background | |
| --- | --- | --- |
| 2.1. | Characterisation of the target patient population This section shall provide a brief description of the target patient population(s) for the indication(s) under assessment, in line with the intended purpose of the IVD. | |
| --- | --- | --- |
| 2.2. | Characterisation of the in vitro diagnostic medical device This section shall describe characteristics of the in vitro diagnostic medical device under assessment (‘the IVD’) and report the following information: (a) manufacturer (as mentioned on the certificate of conformity) and HTD submitting the JCA dossier, if different from the manufacturer; (b) the trade name of the IVD; (c) intended purpose; (d) model(s) of the IVD including description of the different references / reference number(s) / software version; (e) European Nomenclature on Medical Devices (EMDN) 13 description (most granular level, as relevant); (f) brief description of the IVD including its components in case the IVD is a kit; (g) specification of the analyte or marker to be determined by the IVD (e.g. SARS- CoV-2 spike protein, Kel1 (K)); (h) principle of the assay method or principles of operation of the instrument (e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.); (i) whether it is automated or not; (j) whether it is qualitative, semi-quantitative or quantitative; (k) type of specimen(s) required (e.g. whole blood, serum, saliva etc.); (l) intended user (e.g. self-testing, near patient and laboratory professional use, healthcare professionals); (m) instructions for use, necessary training and experience of the user, appropriate calibration procedures and means of control, indication of any other devices, medical devices, medicinal product or other articles to be included or excluded. | |
| --- | --- | --- |
| 2.3. | Regulatory status of the IVD This section shall describe the regulatory information on the IVD. | |
| --- | --- | --- |
| 3. | Assessment scope This section shall reproduce the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282. | |
| --- | --- | --- |
| 4. | Results The results presented in this section shall follow international standards of evidence-based medicine. | |
| --- | --- | --- |
| 4.1. | Information retrieval This section shall include: (a) a description of the information retrieval performed by the HTD; (b) an assessment of the search strategy of the HTD. Detailed information shall be provided in Appendix B. | |
| --- | --- | --- |
| 4.1.1. | Resulting list of included studies overall and by PICO This section shall provide in tabular format: (a) an overview of all included studies and the associated references for these studies overall and by PICO; (b) the list of studies included by the HTD which were excluded within the assessment, with a justification for their exclusion. | |
| --- | --- | --- |
| 4.2. | Characteristics of included studies | |
| --- | --- | --- |
| 4.2.1. | Included studies This section shall provide for the studies included in the assessment: (a) information on the study design; (b) information on enrolled study populations; (c) characteristics of the study interventions; (d) information on the course of the study; (e) information on the study duration. | |
| --- | --- | --- |
| 4.2.2. | Degree of certainty with regard to the PICO(s) This section shall describe the assessment of degree of certainty with regard to the PICO(s). | |
| --- | --- | --- |
| 4.3. | Study results on relative effectiveness and relative safety The results on relative effectiveness and relative safety shall be presented according to the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282, per PICO. An assessment of the degree of certainty of the relative effectiveness and relative safety, considering the strengths and limitations of the available evidence. | |
| --- | --- | --- |
| 4.3.1. | Results for patient population This section shall discuss to which extent the included patient populations and/or comparator(s) per study cover the relevant patient population/comparator(s) according to the assessment scope as set out pursuant to Article 8(6) of Regulation (EU) 2021/2282. A separate section shall be provided for each patient population specified in the PICO(s). Within this section, the results for all PICO(s) addressing this patient population shall be presented in the following sub-sections. | |
| --- | --- | --- |
| 4.3.1.1. | Patient characteristics This section shall present patient characteristics from all studies covering the relevant patient population included in any of PICO(s) addressing this patient population. 4.3.1.2. Evidence synthesis methods This section shall briefly describe, when applicable, the evidence synthesis methods used by the HTD, including the associated strengths and limitations, and any factors arising from these methods and their application which may affect the certainty of the evidence. | |
| --- | --- | --- |
| 4.3.1.3. | Outcome results for PICO <1> and uncertainties in the results Within the given patient population , results on outcomes describing relative effectiveness and relative safety shall be described by PICO. The sub-section shall start by describing and justifying the choice of evidence (type of comparison) submitted to address the given PICO <1>. The sub-section shall present an overview of the available outcomes requested in the assessment scope per study. Results on relative effectiveness and relative safety (i.e., the relative effects of the IVD versus the comparator) shall include the results from all individual studies and if available any quantitative syntheses of results, e.g., from meta-analyses. The results of the analyses of each of the presented outcomes shall be described briefly. The description shall address any issues affecting the degree of uncertainty of the relative effects. For each additional PICO question related to the given patient population , a new sub-section shall be created to present the results in terms of outcomes for this PICO question. | |
| --- | --- | --- |
| 4.3.2. | Results of the main study from the PER of the IVD (if not addressed by any of PICO(s)) | |
| --- | --- | --- |
| 4.3.2.1. | Characteristics of the study | |
| --- | --- | --- |
| 4.3.2.2. | Patient characteristics | |
| --- | --- | --- |
| 4.3.2.3. | Outcome results of the study and uncertainties in the results | |
| --- | --- | --- |
| 5. | References |
Appendixes
| Appendix A. | Input from experts and stakeholders | |
| --- | --- | --- |
| Appendix B. | Assessment of information retrieval | |
| --- | --- | --- |
| Appendix C. | Additional study information and data, including uncertainties in the results |
ANNEX V
TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT SUMMARY REPORT ON A MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
The summary report shall be concise and an independently readable overview of the assessment.
The summary report shall include, at least the following information:
- (a) a description of the intervention, medical condition and/or target population;
- (b) the assessment scope provided for in Article 8(6) of Regulation (EU) 2021/2282;
- (c) information on the involvement of patients, clinical experts and other relevant experts, as well as on the input received from patient organisations, healthcare professional organisations and clinical and learned societies;
- (d) summary tables including uncertainties of the evidence for each set of parameters for the joint clinical assessment in terms of patient population, intervention, comparators and outcomes, with short description of the results.
ELI: http://data.europa.eu/eli/reg_impl/2025/2086/oj
ISSN 1977-0677 (electronic edition)
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