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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 Â 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.
- Quality Of the Technical File submitted to Notified Body
- Supporting justification and supporting evidence provided to prove the safety and performance of the device
- Labeling information etc.
More information about CE Marking Process for Medical Device, please write to enquiry@i3cglobal.com. Our expert consultants can give you further guidance!
