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CE Marking Approval Process

If you are new to the CE Marking Approval Process for Class IIa, IIb or III medical devices, below-given details will provide adequate information (in general), with various steps involved in the complete CE Certification process.

CE Marking Approval / Certification of Medical Device depends on the following factors mainly

 

5 Phases CE Marking Approval

PHASE I

STAGES

IDENTIFICATION, COLLECTION, COMPILATION AND REVIEW OF DATA

RESPONSIBLITY

TIME

1

  • PRODUCT NAME AND TRADE NAME
  • GENERAL DESCRIPTION OF DEVICE
  • INTENDED PURPOSE
  • INTENDED USERS

Manufacturer

20 Days

2

PRODUCT IDENTIFICATION

Manufacturer &

I3CGlobal

3

  • THE INTENDED PATIENT POPULATION
  • MEDICAL CONDITIONS
  • INDICATIONS
  • CONTRA-INDICATIONS
  • WARNINGS

Manufacturer

4

  • PRINCIPLE OF OPERATION
Manufacturer

I3CGlobal

10-20 Days

6

  • EXPLANATION OF NOVEL FEATURES
  • DESCRIPTION OF THE ACCESSORIES

I3CGlobal

   7 LIST OF VARIANTS

COMPONENTS DESCRIPTION

DESCRIPTION OF THE RAW MATERIALS

Manufacturer

8

 

TECHNICAL SPECIFICATIONS

Manufacturer &

I3CGlobal

9

  • OVERVIEW OF THE PREVIOUS GENERATION
  • OVERVIEW OF EQUIVALENT DEVICES
  • OVERVIEW OFSIMILAR DEVICES

Manufacturer

10

MANUFACTURER SUPPLIED INFORMATION

  • Primary Labels
  • Instruction for Use/ User Manual
  • Specimen of Patient Implant Card

I3CGlobal

11

DEVICE DESIGN FILE

Manufacturer

12

MANUFACTURING PROCESS

  • Manufacturing Process Flow Chart
  • Process Validation Report

Manufacturer &

I3CGlobal

13

FINAL PRODUCT SPECIFICATION

  • Quality Plan for Finished Product
  • Finished Product Specification
  • Final Product Test Reports

Manufacturer

&

I3CGlobal

PHASE III

14

MANUFACTURING ENVIRONMENTAL CONTROLS

Manufacturer

10 Days

15

SUPPLIERS AND SUBCONTRACTORS

Manufacturer

16

THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

I3CGlobal

17

  • DECLARATION OF CONFORMITY
  • APPLICABLE LEGISLATION
  • APPLICABLE GUIDELINES
  • APPLICABLE HARMONIZED STANDARDS
  • APPLICABLE NON- HARMONIZED STANDARDS

I3CGlobal

PHASE  IV

18

BENEFIT-RISK ANALYSIS

AND RISK MANAGEMENT

I3CGlobal

30-90 Days

19

  • PRE-CLINICAL SAFETY
  • BIOCOMPATIBILITY OF THE DEVICE
  • ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY

Manufacturer &

I3CGlobal

20

POST MARKET ACTIVITIES

I3CGlobal

21

CLINICAL EVALUATION REPORT

I3CGlobal

22

I3CGlobal

90 Days

PHASE V

23

SOFTWARE VERIFICATION AND VALIDATION

Manufacturer

10 Days

24

Submission of Technical File to NB

I3CGlobal

30 Days

25

NOTIFIED BODY REVIEW & APPROVAL

  • Technical File Review
  • Correction and Resubmission of Technical File
  • Onsite Inspection
  • Issue of CE Certificate

I3CGlobal

&

Notified Body

150-300 Days

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