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CE Marking Approval Process 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.

5 Phases CE Marking Approval

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

ISO 62304 Implementation (SAMD devices only)

Manufacturer + I3C

12

Identify Notified Body and submit MDR Application.

Manufacturer + I3C

13

Appointment of  EC Representative (EAR)

(Non-European Manufacturers only)

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

For more information, readers are requested to scroll down the below pages or fill up the quick contact form.

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