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REQUIREMENT
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SCOPE OF I3CGLOBAL
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SCOPE OF MANUFACTURER
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I.
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The introduction of EU MDR requires the update of the content of the CER. The clinical safety and efficacy need to be proved with proper clinical evidence for all classes of devices. This applies to legacy devices which are already on the market as well as new devices which are to be introduced into the market |
The impact assessment of the requirements of the MDR relating to the products to be identified, which includes a review of the device’s updated classifications and the associated regulatory and quality system requirements. This assessment helps in understanding the documentation impact of the EU MDR on the CERs and also determines the further steps to be taken for ensuring their compliance to EU MDR regulation. |
Inform I3C all the information related to the device and its components with at most accuracy. |
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II.
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Route / Method |
Identify which route to perform the Clinical Evaluation – Literature search + pre-clinical evidence OR Clinical Investigation OR based on Article 61(10) [Clinical data not deemed appropriate] |
Provide Clinical Investigation Report (if available), technical file of the device (if available), pre-clinical or bench test reports, RMF, PMSR/PSUR, PMCF study report, User guide/IFU. |
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STAGE 0 – Scoping & Planning
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0.1
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Clinical Evaluator |
- Guidance and drafting of templates for the declaration of Interest.
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- Identify and appoint a Clinical Evaluator
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0.2
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Develop Clinical Evaluation Procedure in line with standard requirements.
- Clinical Evaluation Plan
- Literature Search Plan
- Appraisal Plan
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- Develop procedure and or modify customer supplied procedure(s)
- Develop the necessary record templates in line with procedure and develop strategies for scoping and activity planning, literature search and appraisal.
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- Clarify doubts, when necessary.
- Assign responsibilities.
- Review and approve.
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STAGE 1- Identification of Pertinent Data
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1.1
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Data Retrieved from the Manufacturer |
- Develop detailed SOP.
- Develop Identification of Pertinent Data template
- Guides manufacturer on pre-clinical and non-clinical studies.
- Identifies data that can be retrieved from manufacturer and adds data based on that to the template.
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- Extend necessary support for consultants with pre-clinical data in a systematic way.
- Provide information of any clinical studies such as Clinical investigations as ISO 14155 or Post-market studies on the device
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1.2
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Literature Search and Review Report |
- Develop detailed SOP.
- Develop relevant Literature search and review report template.
- Perform a systematic and comprehensive literature search from scientific databases based on research questions to meet the requirements of Annex I, GSPR [MDR] and SOTA/SOA, and prepares the literature search report for meeting the requirement of safety and performance of the device.
- Prepares literature search review report based on the review questions added in Literature search plan.
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STAGE 2 – Appraisal of Pertinent Data
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2.1
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Demonstration of Equivalence (if applicable) |
- Develop detailed SOP.
- Develop Demonstration of Equivalence template based on MDCG guidance.
- Demonstration of equivalence, if applicable
- Inform about similar device details obtained from pieces of literature (if any)
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- Identification of equivalent device and provide the details for demonstration of equivalence (if claiming the equivalency)
- As applicable, a contract must be signed between your company and the manufacturer of the equivalent device if your product is Class III or implantable or must have access to equivalent device data on an on-going basis, if any other classes (if applicable)
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2.2
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Appraisal of Pertinent Data |
- Develop detailed SOP.
- Develop appraisal of pertinent data template
- Appraises the clinical data collected from the manufacturer as well as that from the literature search based on the criteria set in the Appraisal plan.
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STAGE 3 – Analysis of Clinical Data
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3.1
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Analysis of the Clinical Data |
- Develop detailed SOP.
- Develop analysis of clinical data template
- Perform qualitative analysis of the clinical data obtained from the literature as well as data retrieved from the manufacturer based on the essential requirements and corresponding GSPRs.
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STAGE 4- Development of CER
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4.1(a)
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Risk Management
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IFU/User guide/User Manual |
- Develop or modifies the Risk Management Procedure and templates based on EN ISO 14971, if required.
- Reviews, guides, and makes necessary modifications on manufacturer’s RMF.
- Benefit-Risk Determination and Conclusion review and suggestion
- Suggests changes in the IFU/User guide based on the inputs from the CER, RMF, PMS, PSUR and PMCF
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- Share the existing Risk procedure and RMF.
- Modify RMF/IFU based on the outputs of CER.
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4.1(b)
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Post Market Surveillance and Vigilance Reporting
(Active, Non-active, Implantable and Software Devices) |
- Develop or modifies the PMS procedure.
- Develop templates such PMS plan, Data Analysis Plan & Report, Sales Data, Customer Feedback, User Feedback and Review of PMS Plan, as needed.
- Support in the PMS planning.
- Reviews the collected data based on the PMS sources.
- Preparation of PMS report for Class I device
- Drafts or guides in the preparation of Vigilance procedure and associated templates
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- Extend necessary support by following PMS plan scheduled for the PMS period.
- Collect PMS data based on the PMS sources chosen – Organize Sales History and Sales volume data, Customer and User Feedback
- Review and approval of PMS plan, Data analysis plan & report and the evidence
- Review and approval of PMSR and reports associated with Vigilance.
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4.1(c)
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Post Market Clinical Follow-up
(Active, Non-active, Implantable and Software Devices) |
- Prepares procedure for PMCF, if required.
- Prepares PMCF Plan & Evaluation Report templates based on the MDCG guidance.
- Supports in selection of device for PMCF.
- Prepares PMCF plan.
- Guides to choose the suitable PMCF methods (general and specific) as per the characteristics and type of medical devices.
- Verifies the findings and the results based on the PMCF methods chosen Compiles the PMCF evaluation report.
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- Extend necessary support by following the PMCF plan by following the PMCF period selected in line with the PMS.
- Identify methods of PMCF based consultant’s inputs.
- Perform the general and specific PMCF activities such as Surveys and Clinical Investigation (If applicable)- to be outsourced to a third-party agency.
- Review and approve PMCF plan, other evidence and PMCF Evaluation Report
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4.1(d)
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Periodic Safety Update Report
(Active, Non-active, Implantable and Software Devices)
(Not applicable for Class I devices) |
- Develop PSUR template based on MDCG guidance, as needed.
- Reviews the collected data and evidence based on the PMS sources.
- Preparation of PSUR for risk class IIa and above
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- Extend necessary support by following PMS plan scheduled for the PMS period.
- Collect PMS data based on the PMS sources chosen – Organize Sales History and Sales volume data, Customer and User Feedback or any other relevant information requested.
- Review and approve the summarized evidence of PMS data in the PSUR.
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| 4.1 |
Clinical Evaluation Report |
- Develop detailed SOP.
- Develop CER template.
- Adds information on the CER template based on the summary of inputs from the clinical data provided by the manufacturer and/or the literature or from the Clinical investigation report from stage 1 to stage 3 meeting the GSPRs.
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- Review and approve CER by the assigned Clinical Evaluator(s).
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