CE Marking Approval Process
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 CE Mark approval 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.
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 Marking 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 CE marking consultant.
I3CGLOBAL helps manufactures to obtain MDR CE Marking Approval
- 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
MDR CE Marking Approval Process, Timeline and Responsibilities
PHASE I |
STAGES |
IDENTIFICATION, COLLECTION, COMPILATION AND REVIEW OF DATA |
RESPONSIBILITY |
TIME |
1 |
|
Manufacturer |
10 Days |
|
2 |
PRODUCT IDENTIFICATION
|
Manufacturer & I3CGlobal |
||
3 |
|
Manufacturer |
||
4 |
|
Manufacturer | ||
5 |
|
I3CGlobal |
10-20 Days |
|
6 |
|
I3CGlobal |
||
7 |
|
Manufacturer |
||
8 |
TECHNICAL SPECIFICATIONS |
Manufacturer & I3CGlobal |
||
9 |
|
Manufacturer |
||
10 |
MANUFACTURER SUPPLIED INFORMATION
|
I3CGlobal |
||
11 |
DEVICE DESIGN FILE |
Manufacturer |
||
12 |
MANUFACTURING PROCESS
|
Manufacturer & I3CGlobal |
||
13 |
FINAL PRODUCT SPECIFICATION
|
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 |
|
I3CGlobal |
||
PHASE IV |
18 |
BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT |
I3CGlobal |
30-90 Days |
19 |
|
Manufacturer & I3CGlobal |
||
20 |
POST-MARKET ACTIVITIES
|
I3CGlobal |
||
21 |
CLINICAL EVALUATION REPORT |
I3CGlobal |
||
22 |
|
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
|
I3CGlobal & Notified Body |
150-300 Days |
Frequently Asked Questions About CE Marking
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 approval 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.