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CE Marking Process

MDR CE Marking Process

Below table explains the role of CE Marking Consultants and manufacturer during technical documentation and Notified Body review.

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