1. PREPARED FOR

APPLICANT

MANUFACTURER [OEM]
OWN BRAND OWNER [OBL]

Applicant Name and Full Address
(To be printed in the agreement and registration document)

CONTACT PERSON

MANUFACTURER
APPLICANT REPRESENTATIVE / CONSULTANT



2. PREPARED BY
Alsstr. 97, 41063 Mönchengladbach, Germany
S-8, JJ Park 2, 4th Cross, Bangalore-560029, India
58, Peregrine Road, Essex, England, IG6 3SZ, UK
75 Executive Drive, 303, Aurora, Illinois-60504, USA
R2202 CT2B, 609 Truong Dinh, Hoang Mai, Hanoi, VN
NAME
CONTACT NUMBER
EMAIL
DATE
PROPOSAL NUMBER I3C-EAR--REV:
PROPOSAL VALIDITY
 
3. EXECUTIVE SUMMARY

The business proposal submitted to manufacturer / client representative with full confidence in the EU Regulation, European Authorized Representative duties and responsibilities and EU registration requirements.

Technical inputs submitted by the manufacturer to I3CGLOBAL for onward submission to EU Authorities must be authentic and genuine.

All documents /files with us will not be shared to any organization or person. We assure complete data protection of customer supplied data files. We are ISO 27701:2016 Certified.
4. DEVICE INFORMATION

Number of Devices

Regulation

1. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

2. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

3. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Varients

4. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

5. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

6. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

7. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

8. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

9. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants

10. Device Name & Brand Name

    Device Class/GMDN Code

    Model(s)/Variants
5. PROJECT FEES
Phase 1: Annual European Authorized Representative
Optional: Review/Prepare Declaration of Confirmity
Optional: Review of Technical File
Phase 2: 2.1 EU Registration
  2.2 EUDAMED Registration (Actor & SRN activation only)
  2.3 UDI Submission
Phase 3: 3.1 FSC Processing
  3.2 FSC Attestation
Total:  
In Words:

Payments must be made on tax invoices issued in accordance with the applicable government laws in effect at the time of invoicing. We recommend paying using PayPal with an extra 4.7 percent convenience charge for quick processing.
6. GENERAL TERMS OF BUSINESS

6.1 MANDATORY DOCUMENTATION FOR ACTING AS EU REPRESENTATIVE.

  • For all devices covered by clause 4, the manufacturer must keep the most recent edition of the technical file. (Submit to us when asked only)
  • Signed and dated Declaration of Conformity that includes the Device name and brand, as well as the GMDN and model numbers.
6.2 MANDATORY DOCUMENTATION FOR EU REGISTRATION.
  • Technical File latest revision number with a date.
  • Conformity assessment certificates, if available
  • Joint agreement with European Authorized Representative.
  • Responsible person to communicate with Authority (Name, Email & Contact Information)
6.3 AUTHORITIES MAY REQUEST FURTHER DOCUMENTATION DURING REGISTRATION.
  • Biocompatibility Test Reports
    		•
  • Performance Test Reports
    		•
  • Performance Evaluation Reports
    		•
  • Clinical Evaluation Reports
    		•
  • Device Label
    		•
  • Device User Manual / IFU
    		•
  • Electrical Safety Test Reports
    		•
  • Notified Body name and address
    		•
  • Basic UDI-DI
    		•
6.4 NO REFUND.
In the event of registration cancellation due to improper technical documentation, incorrect information submitted, or any device quality problems, we will not refund the fees paid to us.
6.5 TIMELINE.
EAR Agreement drafting and mutual signing will take around 2-3 working days.
EU Registration 5-10 working days.
ACTOR Registration and SRN Activation in 10 working days.
6.6 TECHNICAL DOCUMENTATION.
We provide technical documentation for the devices listed in clause 4 for an extra price. The typical turnaround time is three months.

 
7. PROPOSAL REVIEW
Name : Soio George
Designation : Project Head
Email : sg@i3cglobal.com
Date :

I read, reviewed, and confirmed that the information is accurate to the best of my knowledge. I appreciate the opportunity to present our proposal to you, and I look forward to working with you.

I accept

 
8. PROPOSAL APPROVAL

Name :
Designation :
Email :
Date :

I acknowledge that I have read and understand the working pattern, scope of both parties, risk involved, and potential variations in project assumptions and timetables, and I now accept them. I3CGLOBAL is now requested to submit an advance payment invoice so that the project can begin as soon as possible.

I accept