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

Product Quality
Technical Documentation submitted to Notified Body
Pre-Clinical Test Reports
Clinical Evaluation
User Manual / IFU & Labelling information

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

CE Marking Approval Process for Medical Devices

5 Phases CE Marking Approval

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

CE Marking Approval - Quick Contact

Important Pages