TEMPLATE FOR THE DOSSIER FOR THE JOINT CLINICAL ASSESSMENT OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE
ANNEX IISupplementary provisions
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 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 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 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. 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). 2. Background 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. 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) ( 1 ) 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. 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. 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. 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. 4. Results 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. 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. 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. 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. Appendix B. Information to assess the degree of certainty with regard to PICO(s) Appendix C. Underlying documentation 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 ( 1 ) European Medical Device Nomenclature (EMDN) - EUDAMED .