CE Marking Approval Process

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.

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

5 Phases CE Marking Approval

PHASE I	STAGES	IDENTIFICATION, COLLECTION, COMPILATION AND REVIEW OF DATA	RESPONSIBLITY	TIME
	1	PRODUCT NAME AND TRADE NAME GENERAL DESCRIPTION OF DEVICE INTENDED PURPOSE INTENDED USERS	Manufacturer	20 Days
	2	PRODUCT IDENTIFICATION Basic UDI-DI GMDN Code	Manufacturer & I3CGlobal
	3	THE INTENDED PATIENT POPULATION MEDICAL CONDITIONS INDICATIONS CONTRA-INDICATIONS WARNINGS	Manufacturer
	4	PRINCIPLE OF OPERATION	Manufacturer

		MEDICAL DEVICE RATIONALE DEVICE CLASSIFICATION CLASSIFICATION JUSTIFICATION CONFORMITY ROUTE	I3CGlobal	10-20 Days
	6	EXPLANATION OF NOVEL FEATURES DESCRIPTION OF THE ACCESSORIES	I3CGlobal
	7	LIST OF VARIANTS COMPONENTS DESCRIPTION DESCRIPTION OF THE RAW MATERIALS	Manufacturer
	8	TECHNICAL SPECIFICATIONS	Manufacturer & I3CGlobal
	9	OVERVIEW OF THE PREVIOUS GENERATION OVERVIEW OF EQUIVALENT DEVICES OVERVIEW OF SIMILAR DEVICES	Manufacturer
	10	MANUFACTURER SUPPLIED INFORMATION Primary Labels Instruction for Use/ User Manual Specimen of Patient Implant Card	I3CGlobal
	11	DEVICE DESIGN FILE	Manufacturer
	12	MANUFACTURING PROCESS Manufacturing Process Flow Chart Process Validation Report	Manufacturer & I3CGlobal
	13	FINAL PRODUCT SPECIFICATION Quality Plan for Finished Product Finished Product Specification Final Product Test Reports	Manufacturer & I3CGlobal

PHASE III	14	MANUFACTURING ENVIRONMENTAL CONTROLS	Manufacturer	10 Days
	15	SUPPLIERS AND SUBCONTRACTORS	Manufacturer
	16	THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS	I3CGlobal
	17	DECLARATION OF CONFORMITY APPLICABLE LEGISLATION APPLICABLE GUIDELINES APPLICABLE HARMONIZED STANDARDS APPLICABLE NON- HARMONIZED STANDARDS	I3CGlobal

PHASE IV	18	BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT	I3CGlobal	30-90 Days
	19	PRE-CLINICAL SAFETY BIOCOMPATIBILITY OF THE DEVICE ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY	Manufacturer & I3CGlobal
	20	POST-MARKET ACTIVITIES Post Market Surveillance (PMS) Post Market Clinical Follow up (PMCF) Periodic Safety Update Report (PSUR) Advisory Notice and Product Recall Vigilance Control	I3CGlobal
	21	CLINICAL EVALUATION REPORT	I3CGlobal
	22	Accelerated Stability Study Report Real-time Stability Study Report	I3CGlobal	90 Days

PHASE V	23	SOFTWARE VERIFICATION AND VALIDATION	Manufacturer	10 Days
	24	Submission of Technical File to NB	I3CGlobal	30 Days
	25	NOTIFIED BODY REVIEW & APPROVAL Technical File Review Correction and Resubmission of Technical File Onsite Inspection Issue of CE Certificate	I3CGlobal & Notified Body	150-300 Days

CE Marking Approval Process

5 Phases CE Marking Approval

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