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I3CGLOBAL

Regulatory Consulting Services

Home MDR CE Marking Process

MDR CE Marking Process - Statement of Work

S.NO

ACTIVITY

SCOPE OF I3CGLOBAL

SCOPE OF MANUFACTURER

PHASE 1

1.1

Legal Verification

(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

Device Verification

(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

EU 2017/745 Article II requirements

(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

Design Controls

(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

Design Controls

(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

Risk Analysis & Usability Studies

(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

Pre- Clinical

(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

Production Controls

(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

Device Labelling

(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

Device Storage

(Active, Non-active, Implantable Devices)

  • Review, and approval
  • Confirmation of storage time and condition

7.4

Lifetime / Shelf-Life

(Active, Non-active, Implantable Devices)

  • Guidance, review, and approval
  • Lifetime / Shelf-Life Protocol and Reports

7.5

Packaging Controls

(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

Quality Control

(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

Clinical Evaluation

(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

Post Market Surveillance and Vigilance Reporting

 

(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

Post Market Clinical Follow-up

(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

Periodic Safety Update Report

(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

Notified Body Submission, Review and Site Audit and Issue of Certificate

 

(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