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MDR CE Marking Approval Process

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

 

MDR CE Marking Approval of Medical Devices is based on the following factors: (a) Product Quality (b) Technical Documentation submitted to Notified Body (c) Pre-Clinical Test Reports (d) Clinical Evaluation (e) User Manual / IFU & Labeling information

Documentation, Responsibilities and Timeline involved in the MDR CE Marking Approval Process

PHASE I

STAGES

IDENTIFICATION, COLLECTION, COMPILATION AND REVIEW OF DATA

RESPONSIBILITY

TIME

1

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

Manufacturer

10 Days

2

PRODUCT IDENTIFICATION

Manufacturer &

I3CGlobal

3

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

Manufacturer

4

  • PRINCIPLE OF OPERATION
Manufacturer
5

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 OF SIMILAR 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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