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MDD Clinical evaluation checklist excusive clinical invesitagion route

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MDD Clinical evaluation checklist excusive clinical invesitagion routeDet Norske Veritas Certification AS, Norway Clinical evaluation checklist for Notified Bodies Ref Requirement Fulfilled Comment 0 Conformity without Clinical Data 0.1 Any demonstration of conformity without clinical data (Annex...

MDD Clinical evaluation checklist excusive clinical invesitagion route
Det Norske Veritas Certification AS, Norway Clinical evaluation checklist for Notified Bodies Ref Requirement Fulfilled Comment 0 Conformity without Clinical Data 0.1 Any demonstration of conformity without clinical data (Annex 7.1.5 of 90/385/EEC and Annex X.1.1d of 93/42/EEC) must be adequately justified and based on · the output of the risk management process · viewed in the context of the device-body interaction · the intended clinical performance · the claims of the manufacturer. Adequacy of demonstration of conformity based on performance evaluation, bench testing and pre-clinical evaluation in the absence of clinical evaluation must be duly substantiated. The notified body must review the manufacturer’s justification, the adequacy of data presented and whether or not conformity is demonstrated. · Is the manufacturer’s justification adequate? · Is the performance evaluation, bench testing and preclinical evaluation adequate to demonstrate conformity to the Essential Requirements? Yes No N/A 1 Clinical Evaluation, General 1.1 The manufacturer should include in the technical documentation a statement on the route(s) applied to retrieve the clinical data used to affix the “CE” marking. The statement should make clear whether that clinical data was obtained from the published literature or the results of clinical investigations or a combination of both and shall include an adequate justification of the route(s) selected and a demonstration of equivalency (technical, biological, clinical) and adequacy if clinical data from similar devices have been used. Yes No N/A Clinical literature Published Unpublished Equivalence demonstrated Clinical investigation Combination of literature and investigation data Comment 1.2 The Clinical Evaluation Report and the full clinical data used for CE marking should be included within the technical documentation Yes No N/A 1.3 The manufacturer has clearly documented the objectives and the scope of the clinical evaluation and specified the clinical ER’s [e.g. clinical performance(s), safety, risks and favourable benefit/risk ratio related to intended use, target group(s) and indication(s)] to be met Yes No N/A 1.4 The manufacturer has clearly outlined the performed steps and procedures of clinical evaluation according to this MEDDEV (specifically sections 5 to 9), adequate justification given for deviations Yes No N/A 2 Clinical investigation route Not applicable 3 Clinical literature data A critical evaluation of relevant scientific literature that is currently available relating to safety, performance, design characteristics and intended purpose in the form of a written report 3.1 Methodology 3.1.1 A critical evaluation of relevant scientific literature has been presented Yes No N/A 3.1.2 A search protocol for the identification, selection, collation and review of relevant publications should be written Yes No N/A 3.1.3 The objective of the literature review should be clearly defined Yes No N/A 3.1.4 The types of studies that are relevant to the objective of the literature review should be specified Yes No N/A 3.1.5 Data should be taken from recognised scientific publications. Unpublished data should also be taken into account in order to avoid publication bias. Yes No N/A 3.1.6 The literature review should state: 3.1.6.1 sources of data, extent of the searches of databases or other sources of information Yes No N/A 3.1.6.2 rationale for the selection/ relevance of the published literature Yes No N/A 3.1.6.3 reasons for believing that all relevant references, both favorable and unfavorable, have been identified Yes No N/A 3.1.6.4 criteria for exclusion of particular references together with a justification for this exclusion. Yes No N/A 3.1.6.5 detailed description of the different stages of literature search (including identification, appraisal, analysis and conclusion of hits) Yes No N/A 3.2 Relevance of data presented 3.2.1 A literature review should clearly establish the extent to which the literature relates to the specific characteristics and features of the device under consideration. Yes No N/A 3.2.2 If the published studies do not directly refer to the device in question, the manufacturer must demonstrate equivalence with the device, which is the subject of the published reports. Yes No N/A 3.2.3 To be equivalent, the devices should have similarity with regard to the clinical, technical and biological parameters with special attention to the performance, principles of operation and materials; or if there are differences identified, an assessment and demonstration of the significance these might have on safety and performance must be set out Yes No N/A 3.2.4 The manufacturer must be able to demonstrate the adequacy of the data in addressing the aspects of conformity set out in the objective Yes No N/A 3.3 NB Assessment of clinical data The literature review should make clear the significance that is attached to particular references based on a number of factors. These include: 3.3.1 relevance of the author’s background and expertise in relation to the particular device and/or medical procedure involved Yes No N/A 3.3.2 whether the author’s conclusions are substantiated by the available data Yes No N/A 3.3.3 whether the literature reflects the current medical practice and the generally acknowledged “state of the art“ technologies Yes No N/A 3.3.4 whether references are taken from recognised scientific publications and whether or not they have been reported in peer reviewed journals Yes No N/A 3.3.5 the extent to which the published literature is the outcome of a study/studies which have followed scientific principles in relation to design Yes No N/A 3.4 Critical evaluation of the literature The literature review should contain a critical evaluation of the literature. This critical evaluation should: 3.4.1 be written by a person suitably qualified in the relevant field, and reviewed and approved by an expert knowledgeable in the “state of the art” and able to demonstrate objectivity Yes No N/A 3.4.2 contain a short description of the medical device, its intended functions, description of the intended purpose and application of use Yes No N/A 3.4.3 contain an analysis of all the available data considered, both favourable and unfavourable Yes No N/A 3.4.4 establish the extent to which the literature relates to the specific characteristics and features of the device being assessed, taking due account of the extend of similarity between the device(s) covered by the literature and the device under assessment Yes No N/A 3.4.5 demonstrate that those aspects of the use of the device, including performance, addressed in the clinical part of the risk analysis are met as claimed by the manufacturer, and that the device fulfils its intended purpose as a medical device Yes No N/A 3.4.6 analyse the identified hazards, the associated risks and the appropriate safety measures of patients, medical staff and Yes No N/A 3.4.7 contain a risk analysis relevant to the device design, materials and procedures involved, taking into account any adverse events, results of post-market surveillance studies, modifications and recalls (if known) Yes No N/A 3.4.8 contain a description of the methods of weighting of different papers and the statistical methods of analysis employed taking into account the assessment methods, the type and duration of study and the heterogeneity of the population included within the study Yes No N/A 3.4.9 include an analysis of the market experience of the same or similar devices, including the results of post-marketing studies, post-market surveillance and short- and long-term adverse events Yes No N/A 3.4.10 contain a list of publications appropriately crossreferenced in the evaluation Yes No N/A 3.4.11 if the clinical data relates to an equivalent device, contain a statement that equivalence with all the relevant characteristics has been demonstrated Yes No N/A 3.4.12 include a conclusion with a justification, including an assessment of any probable benefit to health from the use of the device as intended by the manufacturer, against probable risks of injury or illness from such use taking account of the “state of the art”. The conclusions should make clear how the objectives of the literature review have been met and identify any gaps in the evidence necessary to cover all relevant aspects of safety and performance Yes No N/A 3.4.13 The critical evaluation should be signed and dated by the author Yes No N/A 3.5 NB Assessment of the critical evaluation of literature presented by the manufacturer 3.5.1 Are the manufacturers’ conclusions valid? Yes No N/A 3.5.2 Is the data, taken together with the available pre clinical data, sufficient to demonstrate compliance with the essential requirements covering safety and performance of the device in question under normal conditions of use? Yes No N/A 3.5.3 Are the claims made in the device labeling substantiated by the clinical data taken together with the pre-clinical data? Yes No N/A 3.5.4 Was the assessment performed in a critical and objective manner? Yes No N/A 4 Post-market clinical follow up – the notified body should check and review the manufacturer’s post market clinical follow up plan: 4.1 Has the manufacturer presented an appropriate plan for post-market clinical follow up in line with appropriate guidance? Yes No N/A 4.2 If no post-market clinical follow up plan is presented, has this been adequately justified by the manufacturer? Yes No N/A 4.3 Has the manufacturer an adequate post-market surveillance system in place? Yes No N/A 4.4 Has the manufacturer committed to inform the NB of significant updates to their clinical evaluation arising from PMS/PMCF? Yes No N/A 5 Notified Body Decision Making 5.1 In reviewing the evaluation of clinical data submitted by the manufacturer the NB must decide whether the manufacturer has adequately 5.1.1 described and verified the intended characteristics and performances related to clinical aspects Yes No N/A 5.1.2 performed a risk analysis and estimated the undesirable side effects Yes No N/A 5.1.3 concluded on the basis of documented justification that the risks are acceptable when weighed against the intended benefits Yes No N/A 5.2 NB assessment of benefit/risk presented in the clinical evaluation data 5.2.1 the listing and characterisation of the clinical performance of the device intended by the manufacturer and the expected benefits for the patient Yes No N/A 5.2.2 the use of the list of identified hazards to be addressed through evaluation of clinical data Yes No N/A 5.2.3 the adequate estimation of the associated risks for each identified hazard by: a) characterising the severity of the hazard; b) estimating and characterising the probability of occurrence of the harm (or health impairment or loss of benefit of the treatment) (document with rationale) Yes No N/A 5.2.4 the decision on the acceptability of risks in relation to each identified hazard Yes No N/A � Equivalence means: Clinical: used for the same clinical condition or purpose, at the same site in the body, in similar population (including age, anatomy, physiology); have similar relevant critical performance according to expected clinical effect for specific intended use. Technical: used under similar conditions of use; have similar specifications and properties e.g. tensile strength, viscosity, surface characteristics; be of similar design; use similar deployment methods (if relevant); have similar principles of operation. Biological: use same materials in contact with the same human tissues or body fluids. � For example in having demonstrable and appropriate endpoints, inclusion and exclusion criteria, an appropriate and validated number of patients submitted, carried out for an appropriate duration, providing evidence and analysis of all adverse incidents, deaths, exclusions, withdrawals and subjects lost follow-up and identifying an appropriate statistical plan of analysis. Ideally, evidence should be generated from a clinical trial (controlled if appropriate), properly designed cohort/case controlled study, well documented case histories or sequential reports conducted by appropriate experienced experts, whether in relation to the device itself or an equivalent device. If unpublished data is being included in the assessment, the literature review will need to weigh the significance that is attached to each report. � Conclusions should consider the claimed use - indications, contra-indications and instructions for use proposed by the manufacturer. � If not, identify gaps in the demonstration of compliance with the relevant essential requirements or in the demonstration of equivalence that need addressing through the means of a specifically designed clinical investigation(s). 1 ICP-4-5-i3-MDD-f8
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