In Depth IVDR - MDR CE Marking Process Chart

PHASE	DESCRIPTION OF ACTIVITY	SCOPE OF I3CGLOBAL	SCOPE OF MANUFACTURER
PHASE 1	Legal Verification	Review & Approval	Confirmation of scope
		Review & Approval	Confirmation of production site address, Manufacturing Registration Certificate/Company Registration Certificate, incorporation Certificate.
		Review & Approval	Confirmation of critical outsourcing sites
		Review & Approval	Quality Management Certificate i.e., ISO 9001:2015, ISO 13485:2016 etc.
	Device Verification	Review & Approval	Device Models confirmation
		Guidance, Review and Approval.	Generic name
		Guidance, Review and Approval.	GMDN Code
		Review & Approval	Trade Name / Brand Name
		Review & Approval. Confirming device models	Device Variants confirmation (Stock Keeping unit) SKU
		Medical Device Rational
		Guidance, Review and Approval.	Device Description
		Review & Approval, identifying key functional component	Device Components
		Review & Approval	Device Accessories
		Guidance Review and Approval	Hardware / firmware / software
		Guidance Review and Approval	Intended use
		Guidance Review and Approval	Specification
		Risk Classification
		Software Level of Concern
		Review & Approval	Indication
		Review & Approval	Mechanism of Action
		Review & Approval	Connections to the device

PHASE 2	Confirmation of MDR requirements and compliance issues	Identification of regulations
		Harmonized Standards
		Non-Harmonized standards
		Device specific standards
		Other applicable regulations if any
		Declaration of Conformity
		Documentation of additional declarations

PHASE 3	Design Controls (Active, Non-Active Devices) In line with ISO 13485	Procedure establishment for design and development.
		Review & Comments	Development Plan
		Review & Comments	Design & development inputs
		Review & Comments	Design & development outputs
		Review & Comments	Design Verification
		Review & Comments	Design Validation
		Review & Comments	Design Approvals
		Review & Comments	Formulation / Drawings/ Specifications
		Review & Comments	Bill of Material
		Review & Comments	Design & development Review

PHASE 4	Design Controls (Software) In line with ISO 62304	Review & Comments	Development Plan
		Review & Comments	Requirements Analysis
		Review & Comments	Architectural Design
		Review & Comments	Detailed Design
		Review & Comments	Unit Implementation
		Review & Comments	Unit Verification
		Review & Comments	Integration & Integration Testing
		Review & Comments	System Testing
		Review & Comments	Software Configuration Management
		Review & Comments	Software Risk Management Process
		Review & Comments	The code and code reviews
		Review & Comments	Software validation and release.
PHASE 5	Risk Analysis & Usability	Development of Procedures	Team support and suggestions
		Conduct of risk Analysis
		Risk Mitigation
		Risk Benefit analysis
		Risk Management File documentation	Review and approval
		Usability engineering procedure establishment	Team support and suggestions
		Review & Approval	Usability engineering test report

PHASE 6	Pre- Clinical	Biological Evaluation procedure establishment
		Identification of biocompatibility compliance requirements.
		Identification of electrical safety compliance requirements.
		Review and Approval	Biocompatibility Plan
		Review and Approval	Biocompatibility Test Reports

PHASE 7	Production controls	Guidance, review, and approval	Process Flow Chart
		Guidance,	Critical Process identification
		Review and approval	Critical Process validation protocol and reports
		Review and approval	Sterilization Process Validation Protocol
		Review and approval	Sterilization Process Validation Report
		Guidance	Environmental Controls
		Review and approval	Cleanroom Validation protocol and Records
		Review and approval	Bioburden protocol and Records

PHASE 8	Device Labelling	Guidance, review, and approval	Primary / Secondary Labels including embossing’s submit as per guidance
	Information For Use / User manual	Guidance, review, and approval	Develop and submit IFU / User manual as per guidance
	Device Storage	Review, and approval	Confirmation of storage time and condition
	Lifetime / Shelf-Life	Guidance, review, and approval	Lifetime / Shelf-Life Protocol and Reports
	Packaging Controls (Active, Non-Active Devices)	Guidance, review, and approval	Method of Packing
			Packing Validation and Reports
			Transport Validation and Reports

PHASE 9	Quality Control	Review, and approval	Specification of Finished Device
		Review, and approval	Specification of Critical Raw Materials / Components
		Review, and approval	Quality Plan / Control Plan
		Guidance, review, and approval	Certificate of Analysis (COA)
		Guidance, review, and approval	Batch Release
		Review, and approval	Performance Testing
		Review, and approval	Electrical Safety Testing
PHASE 10	Clinical Evaluation	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
		Guidance and drafting of templates	Assign clinical evaluator(s) as per the guidance and arrange the CV and DOI
		Develop detailed 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
		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
		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.
		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)
		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
		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.
		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
PHASE 11	Post Market Surveillance and Vigilance Reporting	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 Vigilance Control Procedure as per MEDDEV 2.12-1 rev 8	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
PHASE 11	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
PHASE 12	Notified Body Submission, Review and Site Audit and Issue of Certificate	Support identification of Notified Body
		Application
		Technical Documentation Submission
		Answering to Notified Body Review comments	Team support and suggestions
		Review draft Certificate	Review draft Certificate
			Accept the electronic and hard copies of the CE Certificate