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Clinical Evaluation Report for Medical Device

Responsibility of Consultant & Manufacturer

I3CGLOBAL obtains positive outcomes by following a tried-and-true method for documenting medical device clinical evaluations. We are rigorous in our CER preparation approach; therefore, we focus a greater emphasis on customer assistance to accomplish better and quicker submissions to NB with fewer person-days and, as a result, lower total expenses for our customers. Here’s how we separated the scope of activities.  Don’t worry looking into the scope of manufacturers responsibility, we will guide you!!

Statement of Work (SOW)

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REQUIREMENT

SCOPE OF I3CGLOBAL

SCOPE OF MANUFACTURER

I.

What type of CER is required? Identify if the Clinical Evaluation Report to be drafted is new (for initial CE marking) or an update to an existing CER Inform I3C if a new or an update to existing CER is required. If an update, provide the previously submitted CER.

II.

Route? 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

STAGE 0 – Scoping & Planning

0.1

Clinical Evaluation Procedure
  • Development of Quality System Procedure, if not available with the manufacturer.
  • I3C may modify or suggest modifications to the manufacturer’s existing QSP.
  • Extend necessary support with document numbering based on MDQMS and control of documents

0.2

CV and Declaration of Interest from the Clinical Evaluator(s)
  • Guidance and drafting of templates
  • Assign clinical evaluator(s) as per the guidance and arrange the CV and DOI

0.3

  • Clinical Evaluation Plan
  • Literature Search Plan
  • Appraisal Plan
  • Develop detailed SOP for Clinical Evaluation Plan
  • Develop the CEP template and fill it based on the evidence provided by the manufacturer such as IFU or User guide, RMF or previous CER.
  • Develop Literature search plan template and add information of literature search strategies.
  • Develop Appraisal plan template and add information – the criteria for appraisal of all the pertinent data.
  • Clarify doubts, when necessary.
  • Assign other responsible personnel involved in clinical evaluation and inform I3C
  • Review and approve CEP, Literature search plan and Appraisal plan

STAGE 1- Identification of Pertinent Data

1.1

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
  • 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

1.2

Literature Search and Review Report
  • Develops detailed SOP
  • Develops relevant Literature search and review report template
  • Performs 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.
 

STAGE 2 – Appraisal of Pertinent Data

2.1

Demonstration of Equivalence (if applicable)
  • Develops detailed SOP
  • Develops Demonstration of Equivalence template based on MDCG guidance
  • Performs demonstration of equivalence
  • Informs about similar device details obtained from pieces of literature (if any)

 

  • 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)

2.2

Appraisal of Pertinent Data
  • Develops detailed SOP
  • Develops 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
 

STAGE 3 – Analysis of Clinical Data

3.1

Analysis of the Clinical Data
  • Develops detailed SOP
  • Develops analysis of clinical data template
  • Performs 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.
 

STAGE 4- Development of CER

4.1

Clinical Evaluation Report (CER)
  • Develops detailed SOP
  • Develops 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
  • Review and approve CER by the assigned Clinical Evaluator(s).

4.2a

Risk Management
  • Develops 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
  • Share the existing Risk procedure and RMF.

4.2b

Post Market Surveillance
  • Develops or modifies the PMS procedure, if required
  • Analysis based of collected PMS data based on the reactive and proactive sources selected by the manufacturer.
  • Support PMS planning
  • PMS period confirmation
  • Supports in selecting the sources from our PMS Plan provided by us.
  • Guidance on Vigilance and CAPA if required.
  • Decision on whether PMCF study needs to be conducted based on the feedback and risk classification
  • Preparation of PMS report if Class I or PSUR if class IIa and above
  • Extent necessary support by following PMS plan scheduled for the period.
  • Collect PMS data based on the PMS sources chosen
  • Organize Customer Feedback
  • Organize Sales History and Sales volume data
  • Organize User Feedback in the drafted and provided.
  • Follow Vigilance and CAPAs if any required.
  • Review and approve PMS plan, other evidence and PMSR/PSUR

4.2c

Post Market Clinical Follow-up
  • Prepares procedure for PMCF, if required.
  • Prepares PMCF Plan & Evaluation Report templates based on the MDCG guidance
  • Support in selection of device for PMCF
  • Review the data entered in the PMCF plan to meet the chosen PMCF objective
  • Guides manufacturer to choose the suitable method as per the characteristics and type of medical devices.
  • Develops a well-defined PMCF study template and PMCF evaluation report template
  • Verifies the findings and the results based on the PMCF activity chosen by the manufacturer.
  • Analysis & Conclusion based on the study (by the evaluator) in the PMCF evaluation report.
  • Extend necessary support by following the PMCF plan
  • Follow PMCF period selected in line with the PMS
  • Identify List of Study Centres
  • Method of PMCF study based on Consultants Inputs
  • Clinical Investigation (If applicable) to be outsourced to third party agency
  • Review and approve PMCF plan, other evidence and PMCF Evaluation Report

4.2d

IFU/User guide/User Manual
  • Suggests changes in the IFU/User guide based on the inputs from the CER, RMF, PMS, PSUR and PMCF
  • Review and approvals in all the documents
  Additional Services offered for PSUR, Benefit-Risk Determination and Conclusion