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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)