EU IVDR CE Marking Process

ACTIVITY

SCOPE OF I3C

SCOPE OF MANUFACTURER

PHASE 1

PHASE 2

Request, review, guide and approve

Request, review, guide and approve

PHASE 3

Review and Feedback

Documentation as per ISO 13485

• Design and Development Procedure
• Development Plan
• Design and development inputs
• Design and Development outputs.
• Design Verification
• Design Validation
• Design Approvals
• Formulation/Drawings/Specification
• Bill of Materials
• Design and Development Review

• Development Plan
• Requirements Analysis
• Architectural Design
• Detailed Design
• Unit Implementation
• Unit Verification
• Integration and Integration Testing
• System Testing
• Software Configuration Management
• Software Risk Management Process
• The code and code reviews
• Software validation and release

PHASE 4

• Conduct of Risk Analysis
• Team support and suggestions

PHASE 5

PHASE 6

• Protocol and reports

• Validation protocol
• Validation Report

• Protocols
• Reports
• Supporting Evidence
• Bioburden protocol and Records

PHASE 7

Device information Panel

• Primary/Secondary Labels
• Device embossing

• Lifetime
• Shelf-Life

• Method of packing
• Packing validation protocol/reports
• Transport
• Transport validation protocol and reports

PHASE 8

PHASE 9

• I3C may modify or suggest modifications to the manufacturer’s existing QSP.

• Extend necessary support with document numbering based on IVD MDQMS and control of documents

• Assign Performance evaluator(s) and arrange the CV and DOI

• Develop the PEP template and fill it based on the clinical evidence provided by the manufacturer such as IFU or User guide, RMF, or previous PER.
• Develop a Literature search plan template and add information on literature search strategies.
• Develop an Appraisal plan template and add information – the criteria for appraisal of all the pertinent

• Clarify doubts, when necessary.
• Assign responsibilities.
• Review and approve PEP, Literature search plan, and Appraisal plan

• Guides manufacturers on pre-clinical and non-clinical studies.
• Identifies clinical evidence that can be retrieved from the 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 on any clinical studies such as Clinical performance studies as ISO 20916 or Post-market studies on the device

• 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 [EU IVDR 2017/746], and SOTA/SOA, and prepare the literature search report for meeting the requirement of safety and performance of the device.
• Prepare a literature search review report based on the review questions added to the Literature search plan.

• Develop a Demonstration of Equivalence in PER based on MDCG 2020-5 guidance.
• Performs Demonstration of equivalence, if applicable
• Inform 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)
• Must have sufficient access to equivalent device data on an ongoing basis (if applicable)

• Develop appraisal of clinical evidence plan template.
• Appraises and performs qualitative analysis of the clinical data obtained from the literature as well as clinical evidence retrieved from the manufacturer based on corresponding GSPRs and also on the criteria set in the Appraisal plan.

• Develop PER template.
• Adds information on the PER template based on the summary of inputs from the clinical evidence provided by the manufacturer and/or the literature or from the Clinical performance study report from step 1 to step 3 meeting the GSPRs.

• Develops or modify the PMS procedure, if required
• Analysis based on 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 a PMPF study needs to be conducted based on the feedback and risk classification.
• Preparation of PMS report of Class A and B or PSUR if Class C and D

Vigilance Control Procedure as per MEDDEV 2.12-1 rev 8

• Extent necessary support by following the 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

• Prepares procedure for PMPF, if required.
• Prepares PMPF Plan & Evaluation Report templates based on the MDCG guidance.
• Support in the selection of devices for PMPF.
• Review the data entered in the PMPF plan to meet the chosen PMPF objective.
• Guides manufacturers to choose the suitable method as per the characteristics and type of IVD medical devices.
• Develop a well-defined PMPF study template and PMPF evaluation report template.
• Verifies the findings and the results based on the PMPF activity chosen by the manufacturer.

Analysis & Conclusion based on the study (by the evaluator) in the PMPF evaluation report.

• Extend necessary support by following the PMPF plan.
• Follow the PMPF period selected in line with the PMS.
• Identify a List of Study Centres
• Method of PMPF study based on Consultants Inputs
• Clinical Performance study (If applicable) to be outsourced to a third-party agency.

Review and approve the PMPF plan, other evidence and the PMPF Evaluation Report

PHASE 10