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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!!

Scope of Work In Detail

STAGE 0

 

DOCUMENTATION

SCOPE OF WORK

(I3CGLOBAL)

SCOPE OF WORK

(MANUFACTURER)

0.1

CV and Declaration of Interest of the Clinical Evaluator (templates) CV and DOI template preparation and guidance  

Assign clinical evaluator(s) who is/are qualified as per sec 6.4 of Meddev 2.7/1. Rev. 4

0.2

QSP for Clinical Evaluation
  • Development of Quality System Procedure(s) (QSP), SOPs and templates as per CLIENT MDQMS /GMP relevant for MDR documentation related to Clinical Evaluation

 

  • Clinical Evaluation Planning

 

  • Plans for the literature search based on the keywords as per the PICO

 

  • Plans for the appraisal of pertinent data
  • Provide documentation numbering according to the control of documents of CLIENT QMS system

 

  • Provide some inputs for the clinical evaluation plan, Literature Search Plan & Appraisal Plan

0.3

SOP for Clinical Evaluation Plan

0.4

Clinical Evaluation Plan, Literature Search Plan & Appraisal Plan

STAGE 1

 

DOCUMENTATION

SCOPE OF WORK

(I3CGLOBAL)

SCOPE OF WORK

(MANUFACTURER)

1.1

SOP for Identification of Pertinent Data  

  • Formats SOPs and templates as per CLIENT MDQMS /GMP
  • Identifies data that can be retrieved from CLIENT and adds data based on that to the template

 

  • Performs a systematic and comprehensive literature search from scientific databases based on research questions to meet the requirements of Annex I, MDR [GSPR] and prepares the literature search report for meeting the requirement of safety and performance of the device
 

  • Provide information on preclinical studies and non-clinical studies

 

  • Provide information of any clinical studies such as Clinical investigations as ISO 14155 or Post-market studies on the device as per the I3C team request

 

1.2

Data Retrieved from the Manufacturer

1.3

SOP for Literature Search and Review

1.4

Literature Search and Review Report

STAGE 2

 

DOCUMENTATION

SCOPE OF WORK

(I3CGLOBAL)

SCOPE OF WORK

(MANUFACTURER)

2.1

SOP for Demonstration of Equivalence
  • Formats SOPs and templates as per CLIENT MDQMS /GMP

 

  • Performs demonstration of equivalence (As applicable, a contract has to be signed between your company and the manufacturer of the equivalent device)
  • Informs about similar device details obtained from pieces of literature (if any)

 

  • Appraises the clinical data collected from the CLIENT as well as that from the literature search
  • A contract between CLIENT and equivalent device manufacturer (if applicable)
  • Identification of equivalent device and provide the details for demonstration of equivalence (if claiming the equivalency)

 

2.2

Demonstration of Equivalent Devices

2.3

SOP for Appraisal of Pertinent Data

2.4

Appraisal of Pertinent Data

STAGE 3

 

DOCUMENTATION

SCOPE OF WORK

(I3CGLOBAL)

SCOPE OF WORK

(MANUFACTURER)

3.1

SOP for Analysis of the clinical data  

  • Formats SOPs and templates as per CLIENT MDQMS /GMP
  • Performs qualitative Analysis of the clinical data obtained from the literature as well as data retrieved from the CLIENT

3.2

Analysis of the clinical data

STAGE 4

 

DOCUMENTATION

SCOPE OF WORK

(I3CGLOBAL)

SCOPE OF WORK

(MANUFACTURER)

4.1

SOP for Development of CER
  • Formats QSP, SOPs and templates as per CLIENT MDQMS/GMP

 

  • Creates the CER based on the summary of inputs from clinical data from CLIENT and the literature from stage 1 to stage 3 meeting the GSPRs

 

  • Reviews, guides, and makes necessary modifications on CLIENT RMF
  • For PMS – Data collection and Analysis based on the reactive and proactive sources selected by CLIENT, Preparation of PMS report with CLIENT’s support

 

  • For initial PSUR- Benefit-risk determination and conclusion

 

  • For PMCF – Supports in the selection of the model or variant for the study, Prepares PMCF Plan & Evaluation Report

 

  • Suggests changes in the IFU based on the inputs from the CER, RMF, PMS, PSUR and PMCF
  • Provide documents such as previously submitted CER, RMFs, PMS, PMCF and the IFU/user guide/user manual

 

  • For PMS – PMS Planning, Customer feedback reports of the specified period, Complaint records, CAPA reports, Information of Sales history, Sales volume or any other supportive evidence based on the sources selected for PMS

 

  • For PMCF study – PMCF planning, selection of PMCF study based on I3C inputs, selection of study centres, the appointment of Clinical investigator(s), Analysis, and study conclusion
  • For initial PSUR- Acceptability of benefit-risk profile, Information of usage frequency of the device

 

  • Approvals in all the documents prepared by I3C

4.2

Clinical Evaluation Report with the supporting evidence below:

4.2a

Risk Management Procedure + Risk Management File (Forms/templates)

4.2b

Post Market Surveillance (PMS) Procedure + Forms/Templates of Plan & Report + PMS records (Client must organize as per our guidance) / PSUR Form/Template + Records

4.2c

Post Market Clinical Follow-up (PMCF) Procedure + Forms/Templates for Plan and Evaluation Report+
PMCF records (Client must organize as per our guidance)

4.2d

IFU/User guide/User Manual