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CE Marking Approval For Medical Devices

CE Marking Approval Process

CE Marking approval assures the public that your device conforms with applicable EU legislation and allows your product to be sold in all EU member countries legally. The majority of medical device manufacturers are eager to launch their products because they want to start achieving their financial objectives and want their innovation to start assisting patients.

 

It is essential and mandated by law that you make sure you are abiding by the stringent rules of the medical devices regulations (law of the land) where you intend to sell your device before sales can happen. Failure to do so could create legal hurdles and, more significantly, your end consumers.

 

If you’re not familiar with the MDR Class IIa/IIb/III or IVDR Class A/B/C/D CE Marking approval process, the following information on this page will educate you on all the steps involved in the process. I3CGLOBAL Consultants play a major role in guiding manufacturers through the CE Marking approval process as per MDR and IVDR by

 

  • Taking the most efficient pathway for obtaining CE Marking, considering the device classification and intended use
  • Prepare technical documentation, covering risk management, manufacturing data, and performance data
  • Preparation of a CER that demonstrates the clinical safety and performance of the device based on clinical data
  • Preparation of a PER that demonstrates the performance of the device based on analytical data
  • Help manufacturers choose an appropriate Notified Body for their device’s conformity assessment
  • Submit technical documentation to the Notified Body and manage ongoing communications and responses to review comments
  • Ensure that device labelling meets EU requirements, including language and content specifications
  • Provide European Authorized Representative service for Foreign manufactures

MDR CE Marking Approval Criteria

The MDR CE marking approval criteria for medical devices are governed by the European Union’s Medical Device Regulation depending on the type and risk class of medical device. Here are some key aspects of the approval criteria:

 

  • Conformity Assessment Procedure and route of CE marking
  • Technical Documentation
  • Level of medical device Quality Management System implemented
  • Clinical Evaluation
  • Labelling and Instructions for Use
  • Post-Market Surveillance
  • Post-Market Clinical Follow-Up
  • Risk Management
  • Unique Device Identification (UDI)
  • GAP assessment of MDQMS
  • EU Representative

 

These criteria aim to ensure that medical devices placed on the European market meet high standards of safety, performance, and quality, ultimately safeguarding the health and well-being of patients and users.

MDR and IVDR CE marking consultants are crucial in assisting medical device manufacturers in compliance with EU regulations and ensuring demonstration device safety, efficiency and performance via technical documentation.

IVDR CE Marking Approval Criteria

The IVDR CE marking approval criteria for IVD devices are governed by the European Union’s Invitro Diagnostic Device Regulation 2017/746. Depending on the type and risk class the technical documentation content has to be designed and submitted to notified body. Here are some key aspects of the approval criteria:

 

  • Conformity Assessment Procedure and route of CE marking
  • Technical Documentation
  • Level of Quality Management System implemented
  • Analytical performance characteristics, Analytical sensitivity and Analytical specificity
  • Information on Clinical Performance and clinical evidence-Performance Evaluation Report
  • Information provided in the IFU
  • Post-Market Surveillance
  • Post-market performance follow-up
  • Risk Management
  • Unique Device Identification (UDI)
  • GAP assessment of MDQMS
  • EU Representative

IVDR CE marking approval the role of consultants is noticeable in assisting IVD manufacturers in compliance with EU regulations and ensuring demonstration device performance safety, and efficiency via technical documentation file.

CE Marking Approval Process Flowchart

PHASE I

STAGES

IDENTIFICATION, COLLECTION, COMPILATION AND REVIEW OF DATA

RESPONSIBILITY

TIME

1

  • PRODUCT NAME AND TRADE NAME
  • GENERAL DESCRIPTION OF THE 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
  • 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

We have established a robust presence across Asia, including Malaysia, Vietnam, and India, as well as in the EU, with a focus on Germany the UK, and all across the United States. Numerous medical device manufacturers have entrusted us with their regulatory needs for CE Marking Approval, demonstrating their confidence and trust in our services.

Frequently Asked Questions

Do I3CGlobal help with Technical Documentation?

Yes, we are medical device regulatory consultants and UKRP service providers. We help manufacturers submit technical documentation to Certification bodies for UKCA

Who issue CE Marking Approval for medical devices?

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.

How long does it take to get CE Marking?

Medical 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.

Performance Evaluation of IVD devices and reporting will take around 5-6 months for class C and Class D devices.

What is the EU CE 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, the UKCA mark went into effect. UKCA Certification is provided by Approved Bodies in the United Kingdom. The structure of the technical documentation and requirements is almost the same.