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MDR CE Marking Timeline & Activity Chart

If you are new to the process of CE Marking of Class IIa, IIb or III devices, below details will provide adequate information in general with various steps involved in the complete cycle CE Certification process.

MDR CE Marking is divided into 5 phases

PHASE I

Stages

Activity

Responsibility

Timeline

1

Select the Medical Device and Models /Varients /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, Biocompatablity, Physical, Chemical, Stablity, Validations, Verifications etc.
and US Agent for FDA 510k clearance

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

Manufacturer + I3C

9

Incoming, inprocess and final quality end points / controls in line with 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 Manufactures)

Manufacturer

 

PHASE III

14

Define device description, intended, indication of use, mechanisim of action.

I 3 C

90 Days

15

Patinet 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.

Usablity Engineering and Documentation.

Manufacturer + I3C

20

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

I3C

21

(Sterile Products)

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

Manufacturer

22

EN ISO 13485:2016 Interanl 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 evidences

I3C

210+ Days

25

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

Manufacturer +I3C

10 Days

Looking for more information about the process of MDR CE Certification, please write to enquiry@i3cglobal.com. Our team will understand more about your device