Follow Us:

IVDR CE Marking

Home IVDR CE Marking
IVDR CE Marking

EU IVDR CE Marking Process

Statement of Work (SOW) outlined below for the IVDR CE Marking process explains the activities, and responsibilities of consultants and CE applicants (Manufacturers) along with deliverables, for the on-time completion of technical documentation and submission to a Notified Body for obtaining CE marking under the European Union Medical Device Regulation (EU MDR 2017/746) for an In-Vitro-diagnostic device.

 

This Statement of Work (SOW) is designed to build awareness for newcomers applying for IVDR CE marking. Minor deviations in the steps may be necessary during actual documentation, depending on the device class and intended use.

ACTIVITY SCOPE OF I3CGLOBAL SCOPE OF MANUFACTURER
PHASE 1
Legal Address and Scope Review and approve Legal address
Company Registration Certificate
Incorporation Certificate
Review and approve Critical outsourcing locations if any
Address Confirmation
QMS Implementation Status
PHASE 2
Device Information Request, review, guide and approve Information on Previous Govt. Approvals if any
Device Models Confirmation
Generic name
GMDN Code & EMDN Codes
Trade Name/Brand Name
Device Variants Confirmation
SKU (Stock keeping unit)
Previous and similar generations of the device
Overview of Identified Similar Devices
Medical Device Rationale
IVDR Codes
Device Description & Specifications
Review and Approval Identifying key functional component
Device Components
Device Accessories
Hardware/firmware/software
Request, review, guide and approve Intended use
Specification
Risk Classification, Rule, and Justification
Request, review, guide and approve Software Level of Concern
Indications
Principle of Assay Method (or) Principle of operation of the Instrument
Connections to the device
PHASE 3
Confirmation of IVDR requirements and compliance issues Identification of regulations
Harmonized Standards
Non-Harmonized Standards
Device-Specific Standards and CLSI Guidelines
Other Applicable regulations if any
GSPR Checklist
Declaration of Conformity
Documentation of additional declarations
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
Design Controls (Software) in line with ISO 62304 Review and Feedback Documentation as per ISO 13485 / IEC 62304
  • 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
Risk Analysis & Usability Development of Procedures and Templates and Implementation Guidance and coordination with manufacturer team Support and coordination with consultants in the risk management process.
  • Conduct of Risk Analysis
  • Team support and suggestions
Risk Mitigation
Benefit-Risk Analysis
Risk Management File documentation Review
Usability engineering procedure and template Support and suggestions
Guidance, review and approval Usability engineering report
PHASE 5
Biocompatibility
(It will be applicable based on the type and duration of contact with the human body) 		Biological Evaluation procedure and templates
Identification of biocompatibility compliance requirements
Biocompatibility Plan
Guidance Biocompatibility Test Reports
Product Verification and Validation Request, review, guide and approve Information on the Performance of the device (Analytical Performance)
Request, review, guide and approve Metrological Traceability
Request, review, guide and approve Chemical, Physical, and Biological Properties
PHASE 6
Production Controls Request, review, guide and approve. Process Flow chart
Critical Process Identification
Critical Process Validation
  • Protocol and reports
Sterilization Validation
  • Validation protocol
  • Validation Report
Request, review, guide and approve. Clean Room Validation
  • Protocols
  • Reports
  • Supporting Evidence
  • Bioburden protocol and Records
PHASE 7
Device Labelling Request, review, guide and approve. Device information Panel
  • Primary/Secondary Labels
  • Device embossing
Instructions for Use/User Manual /Leaflet IFU/User Manual
Device Storage Storage / Storage Temperatures
Lifetime/Shelf life
  • Lifetime
  • Shelf-Life
Packaging Controls (Active, Non-Active Devices) Device Packing
  • Method of packing
  • Packing validation protocol/reports
  • Transport
  • Transport validation protocol and reports
PHASE 8
Quality Control Request, review and approve. Specifications of the finished device
Specification of Critical Raw Materials/Components
Quality Plan/Control Plan
Certificate of Analysis (COA)
Batch Release (Batch Manufacturing Record)
Request, review, guide and approve. Performance Testing
Review and approve. Electrical Safety Testing
PHASE 9
Performance 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 IVD MDQMS and control of documents
Guidance and drafting of templates
  • Assign Performance evaluator(s) and arrange the CV and DOI
Develop a detailed Performance Evaluation Plan
  • 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
Performance Evaluation
  • 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.
Post-Market Surveillance and Vigilance Reporting
  • 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
Post Market Performance Follow-up
  • 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
Notified Body Submission, Review, Onsite Audit, and Issue of Certificate or NB Opinion Letter Support in the Identification of Notified Body
NB Application and Contact Signing
Technical Documentation Submission to NB
Answering initial NB review comments and resubmission of TDF Support and suggestions
Answering 2nd round NB review comments and resubmission of TDF
Onsite QMS Audit and closing of NC, s
Review draft IVDR CE Certificate Confirm contents in the IVDR CE Certificate draft
Accept IVDR CE Certificate (Soft/Hard) or Notified Body Opinion Letter

EU IVDR CE Marking Process Flow Diagram

Make a flow chart on class B IVD device for Technical file compilation starts Process Start and scaled 1

More details about Class A, Class A Sterile, Class B, Class C and Class D refer the respective pages.

Submit your email for a reply message with more information, about how we can help you with IVDR CE Marking in seconds.