TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT REPORT OF AN IN VITRO DIAGNOSTIC MEDICAL DEVICE
ANNEX IVSupplementary provisions
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) ( 1 ) 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 <Z-1> 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 <Z-1>, 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 <Z-1>, 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 ( 1 ) European Medical Device Nomenclature (EMDN) - EUDAMED .