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CE Marking Approval Process

If you’re unfamiliar with the CE Marking Approval procedure for medical equipment classified as Class IIa, IIb, or III. In that scenario, the following details (in general) will provide sufficient information about the numerous procedures involved in the entire MDR CE Approval. The CE Marking approval is based on the following criteria:

 

  • (a) Product Quality
  • (b) Technical Documentation submitted to NB
  • (c) Pre-Clinical study reports
  • (d) Clinical Evaluation Reports
  • (e) Residual Risk and Labels.

 

Hundreds of medical device start-up firms are constrained in their resources, and they do not have the time to read the new EU MDR material as thoroughly as we would want. Many start-up CEOs are now wondering if getting the medical device CE Marking in compliance with EU MDR standards is even doable. “Yes, you can!” says the response. All you have to do now is figure out where to begin and who is the right CE marking consultant.

I3CGLOBAL helps manufactures to obtain MDR CE Marking Approval

We have a strong presence in Asia (Malaysia, Vietnam, India), EU (Germany, UK) and the USA. Hundreds of medical device manufacturers have come to us with confidence and trust to outsource regulatory for CE Marking Approval. Among our services are:

  • Assistance with classification & standards
  • Preparation of Technical File
  • Review of labeling, and user manual
  • Verification of compliance with GSPR
  • Preparation of Clinical Evaluation Report
  • GAP assessment of MDQMS
  • Authorized Representative services in Europe
  • Review of risk-benefit data
  • Development VG, PMS, PMCF, PSUR procedures and templates

MDR CE Marking Approval Process, Timeline and Responsibilities

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

  • Basic UDI-DI
  • GMDN Code

Manufacturer &

I3CGlobal

3

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

Manufacturer

4

  • PRINCIPLE OF OPERATION
Manufacturer
5
  • MEDICAL DEVICE RATIONALE
  • DEVICE CLASSIFICATION
  • CLASSIFICATION JUSTIFICATION
  • CONFORMITY ROUTE

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

  • Post Market Surveillance (PMS)
  • Post Market Clinical Follow up (PMCF)
  • Periodic Safety Update Report (PSUR)
  • Advisory Notice and Product Recall
  • Vigilance Control

I3CGlobal

21

CLINICAL EVALUATION REPORT

I3CGlobal

22

  • Accelerated Stability Study Report
  • Real-time Stability Study Report

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

Frequently Asked Questions About CE Marking

What is the EU CE Mark and UKCA Mark?

To market medical devices in the European Union, your product must be CE Marked. CE Marking approval certifies that your medical device conforms with applicable EU legislation and allows your product to be sold in all EU member countries as a legal medical device. When the United Kingdom departed the European Union in January 2021, UKCA marking went into effect. UKCA Certification is provided from Approved Bodies in the United Kingdom. The structure of the technical documentation and requirements almost same.

Who will be issuing CE Certificate?

CE certificate will be issued by Notified Body if the medical device is Class Is/m, IIa, IIb, III, or if your IVD comes within Annex II, List A; Annex II, List B,  or is self-testing.

What will be timeline for CE Marking Approval for Class III type device?

Device testing, pre-clinical studies, clinical evaluation, design documentation, and labelling will take no more than 5-6 months, whereas notified body review will take 6-10 months.