MDR CE Marking Approval Process

CE Marking Approval: Hundreds of medical device start-up firms are constrained in their resources, and they do not have the time to read the new EU MDR material as thoroughly as we would want. Many start-up CEOs are now wondering if getting the medical device CE mark in compliance with EU MDR standards is even doable. “Yes, you can!” says the response. All you have to do now is figure out where to begin and who is the right consultant.

If you’re unfamiliar with the CE Marking approval procedure for medical equipment classified as Class IIa, IIb, or III. In that scenario, the following details (in general) will provide sufficient information about the numerous procedures involved in the entire MDR CE Approval. The approval for CE marking is based on the following criteria:

(a) Product Quality (b) Technical Documentation submitted to NB (c) Pre-Clinical study reports (d) Clinical Evaluation Reports (e) Residual Risk and Labels.

I3CGLOBAL helps manufactures obtain MDR CE Marking Approval

We have a strong presence in Asia (Malaysia, Vietnam, India), EU (Germany, UK) and the USA. Hundreds of medical device manufacturers have come to us with confidence and trust to outsource regulatory for CE marking approval. Among our services are:

Assistance with classification & standards
Preparation of Technical File
Review of labeling, and user manual
Verification of compliance with GSPR
Preparation of Clinical Evaluation Report
GAP assessment of MDQMS
Authorized Representative services in Europe
Review of risk-benefit data
Development VG, PMS, PMCF, PSUR procedures and templates

Request for MDR Proposal

Request for IVDR Proposal

MDR CE Marking Approval Process, Timeline and Responsibilities

PHASE I	STAGES	IDENTIFICATION, COLLECTION, COMPILATION AND REVIEW OF DATA	RESPONSIBILITY	TIME
	1	PRODUCT NAME AND TRADE NAME GENERAL DESCRIPTION OF DEVICE INTENDED PURPOSE INTENDED USERS	Manufacturer	10 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

	5	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

Frequently Asked Questions

What is the EU CE Mark and UKCA Mark?

To market medical devices in the European Union, your product must be CE Marked. CE Marking certifies that your medical device conforms with applicable EU legislation and allows your product to be sold in all EU member countries as a legal medical device. When the United Kingdom departed the European Union in January 2021, UKCA marking went into effect. UKCA Certification is provided from Approved Bodies in the United Kingdom. The structure of the technical documentation and requirements almost same.

Who will be issuing CE Marking Approval certificate?

A CE certificate will be issued by a Notified Body if the medical device is Class Is/m, IIa, IIb, III, or if your IVD comes within Annex II, List A; Annex II, List B, or is self-testing.

What will be timeline for CE Mark Approval for Class III type device?

Device testing, pre-clinical studies, clinical evaluation, design documentation, and labelling will take no more than 5-6 months, whereas notified body review will take 6-10 months.

Important Pages