MDR CE Marking Process - Statement of Work

S.NO

ACTIVITY

SCOPE OF I3CGLOBAL

SCOPE OF MANUFACTURER

PHASE 1

1.1

(Active, Non-active, Implantable, and Software Devices)

• Review of Manufacturing Facility Name and Adress

• Confirmation

• Review Legal compliance (Law of the Land)

• Company Registration Certificate
• Incorporation Certificate
• Confirmation

• Review of outsourced activities and Locations

• Confirmation

• Review of Medical Device QMS such as ISO 13485, 21 CFR 820, or MDSAP

• Explanation of QMS, document structure and organization chart and individuals’ responsibilities

1.2

(Active, Non-active, Implantable, and Software Devices)

• Models, Variants, and sales Code / UDI

• Final List submission

• EMDN Code/ GMDN Code

• Confirmation

• Trade Name / Brand Name

• Final List submission

• Intended Purpose, Indication of Use, Intended Users and Intended Patient Population

• Explanation & Confirmation

• Device Description

• Explanation & Confirmation

• Medical Device Rational

• Contraindication & Warning

• Explanation & Confirmation

• Principle of Operation and Mechanism of action

• Explanation & Confirmation

• Components and Accessories covered in the MDR CE Marking scope.

• Explanation & Confirmation

• Similar Device or Equivalent Device Information

• Provide information with supporting justification.

• Novel / State of Art features / Previous Generations

• Provide information with supporting justification.

• Critical Raw Material / Packing Materia

• Provide information with supporting justification.

• Firmware / software

• Explanation & Confirmation

PHASE 2

2.1

(Active, Non-active, Implantable, and Software Devices)

• Risk Class, Rule, and Justification along with Route of CE Marking

• Harmonized and Non-Harmonized Standards

• Applicable Regulation and Guidelines

• Device / Product Specific Standards

• Other Applicable Regulations if any,

• Declaration of Conformity

• Documentation of Additional declarations

PHASE 3

3.1

(Active, Non-active, Implantable Devices)

• Review and Feedback

• Development Plan

• Design & development inputs

• Design & development outputs

• Design Verification

• Design Validation

• Design Approvals

• Formulation / Drawings/ Specifications

• Bill of Material

• Design & development Review

3.2

(Active and Software Devices)

• Review and Feedback

• Development Plan

• Requirements Analysis

• Architectural Design

• Detailed Design

• Unit Implementation

• Unit Verification

• Integration & Integration Testing

• System Testing

• Software Configuration Management

• Software Risk Management Process

• The code and code reviews

• Software validation and release.

PHASE 4

4.1

(Active, Non-active, Implantable, and Software Devices)

• Development of Procedures and Templates

• Conduct of risk Analysis
• Team support and suggestions

• Guidance

• Risk Mitigation

• Risk Benefit analysis

• Risk Management File documentation

• Review and approval

• Usability engineering procedure and template

• Team support and suggestions

• Review and approval

• Usability engineering report

PHASE 5

5.1

(Active, Non-active, Implantable and Software Devices)

• Identification of Regulatory Requirements

• Biological Evaluation and Planning and Test Identification

• Confirmation

• Review and Comments

• Biocompatibility Test Protocols and Final Reports

• Identification of electrical safety compliance requirements

• Confirmation

• Review and approval

• Safety Reports and Final Reports

PHASE 6

6.1

(Active, Non-active, Implantable Devices)

• Identification of Manufacturing Process, Critical Process Areas, and Air Classification

• Provide Process Flow Chart

• Critical Process

• Critical Process validation protocol and reports

• Sterilization Process Validation Protocol and Reports

• Process Areas and Environmental Controls. Clean room Validation Reports.
• Bioburden Records

PHASE 7

7.1

(Active, Non-active, Implantable, and Software Devices)

• Review, Guide, and Approve

• Make necessary modifications in the primary and Secondary labels as per guidance and submit the final specimen copy.

7.2

Information For Use /
User manual

(Active, Non-active, Implantable and Software Devices)

• Review, Guide and Approve

• Make necessary modifications in IFU / User Manual as per guidance and submit final specimen copy.

7.3

(Active, Non-active, Implantable Devices)

• Review, and approval

• Confirmation of storage time and condition

7.4

(Active, Non-active, Implantable Devices)

• Guidance, review, and approval

• Lifetime / Shelf-Life Protocol and Reports

7.5

(Active, Non-active, Implantable Devices)

• Understanding of device packaging, the material of packaging, and method of packaging followed by a review of supporting evidence submitted by the manufacturer.

• Provide packaging method and material details with supporting evidence.

• Sealing Validation Protocol and Report

• Transport Validation Protocol and Reports

PHASE 8

8.1

(Active, Non-active, Implantable Devices)

• Guidance, review, and approval

• Specification of Finished Device

• Specification of Critical Raw Materials / Components

• Quality Plan / Control Plan

• Certificate of Analysis (COA)

• Batch Release

• Performance Testing

• Electrical Safety Testing

PHASE 9

9.1

(Active, Non-active, Implantable, and Software Devices)

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• Review of QSP, if already available

• Correction of QSP, based on the review, if required

• Drafting QSP and SOPs, if not available

• Provide document numbers based on MDQMS.

• Drafting of templates like CV & DOI for the clinical evaluator, Clinical Evaluation Plan (CEP), Literature Search Plan (LSRP), Clinical Data Appraisal Plan (CDAP), Literature Search & Review Reports (LSRR), & Clinical Evaluation Report (CER)

• Correction based on the review, if required

• Appointment of Clinical Evaluator
• Deliver the CV and DOI of the appointed evaluator.

• Updates the CEP, LSRP, and CDAP with relevant product data.
• Gathers data of equivalent device, if equivalency is claimed, and performs demonstration of equivalence.
• Performs the literature search based on State of the Art (SoTA)
• Performs literature search based on safety, performance, design characteristics and intended purpose.
• Compiles the LSRR
• Gathers data from clinical investigation (if conducted)

• Review and approval of the 3 plans
• Provide requested information like that of information of equivalent device, contracts, etc. if equivalency is claimed.
• Provide CI plans, reports and other relevant data, if conducted

• Compiles data on the CER based on literature search and other collected relevant information.

• Review and approval of the CER

9.2

(Active, Non-active, Implantable and Software Devices)

• Develops or modifies the PMS procedure, if required
• Develops templates such PMS plan, Data Analysis Plan & Report, Sales Data, Customer Feedback, User Feedback and Review of PMS Plan, as needed.
• Supports in 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

• 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.

9.3

(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.

• 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

9.4

(Active, Non-active, Implantable and Software Devices)

(Not applicable for Class I devices)

• Develops 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

• 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.

PHASE 10

10.1

(Active, Non-active, Implantable and Software Devices)

• Identification of Suitable Notified Body

• Application submission with Notified Body

• Technical Documentation Handover

• Technical Documentation Submission to Notified Body

• Answering to Notified Body Review comments.

• Technical Support

• Review draft Certificate.

• Confirmation

• Receive Soft copy and Hard copy of the CE Certificate