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CE Marking Approval for Medical Devices

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.

MDR CE Marking Approval process is divided into 5 phases

PHASE I

Stages

Activity

Responsibility

Timeline

1

Select the Medical Device and Models/Variants/Brands for CE Marking application with Notified Body.

Manufacturer

20 Days

2

Identify Equivalent/Similar Device with same risk class, indication, and technology

Manufacturer + I3C

3

Identify product-specific standards, Harmonized and General standards applicable to the device

Manufacturer + I3C

4

Identify sources (Internal/External) for the Evaluation of Safety, Biocompatibility, Physical, Chemical, Stability, Validations, Verifications, etc.

Manufacturer + I3C

PHASE II

5

Gathering information about Materials, Components, Brought-out Items, Outsourced Items, packing requirement specification along with BOM from Design & Development

I3C

30-45 Days

6

Detailed information about manufacturing Process Flow, environmental conditions.

I3C

7

Details about device packing, Labelling & Transportation

Manufacturer + I3C

8

Detailed assessment about a similar generation(s) of the device available on the European Union or on international markets by the manufacturer.

Manufacturer + I3C

9

Incoming, in-process, and final quality endpoints/controls in line with the final product specification. (Quality Plans/Control Plans)

Manufacturer

10

Version Control/History in case of software devices

I3C

11

?

Manufacturer + I3C

12

Identify Notified Body and submit MDR Application.

Manufacturer + I3C

13

Appointment of E.A.R (for non-European Manufacturers)

Manufacturer

PHASE III

14

Define device description, intended, the indication of use, mechanism of action.

I 3 C

90 Days

15

Patient Population, clinical conditions, contraindication, warnings

I3C

16

Biological evaluation and testing

Manufacturer + I3C

17

Safety and performances requirement analysis and testing

Manufacturer + I3C

PHASE Ā IV

18

Approve and release Design Files

Manufacturer

60-90 Days

19

Risk Identification and Benefit-Risk Analysis.

Usability Engineering and Documentation.

Manufacturer + I3C

20

Clinical Evaluation along with Post Market Surveillance and Periodic Safety Update Report.

I3C

21

(Sterile Products)

Sterilizer validation/Process validation. Sterility Report. Bioburden studies.

Manufacturer

22

EN ISO 13485:2016 Internal GAP Assessment/IQA

I3C

02 Days

PHASE V

23

Consolidation of technical documentation, Internal review, and correction followed by NB submission.

Manufacturer + I3C

60 Days

24

Receive NB review comments, modify/reply to NB with correction and supporting evidence

I3C

210+ Days

25

Onsite QMS & Product Audit followed by the closing of all findings.

Manufacturer +I3C

10 Days

Medical Device CE Marking Approval timeline depends on multiple factors.

  1. Quality Of the Technical File submitted to Notified Body
  2. Supporting justification and supporting evidence provided to prove the safety and performance of the device
  3. Labeling information etc.

More information about CE Marking Process for Medical Device, please write toĀ enquiry@i3cglobal.com. Our expert consultants can give you further guidance!

Post Market Surveillance (SOP & Templates)