You must fill in the details requested to receive a precise IVDR CE Marking service proposal. Based on the data entered below online, we determine the price and timeline. We are aware that this may be quite challenging for startup business owners and manufacturers, but we must have it to properly serve and support you! Do not forget to complete a separate form for each device you intend to CE mark .

Legal Manufacturer Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Website / URL

Notified Body Slected / Interested?

Scope of Manufacturer *

Scope of I3CGLOBAL *

Product Expert *

Currently we do not have a product expert to work with consultant team
Yes, we have product technical expert to provide device information to consultant team
Will appoint if required.

ISO 13485 / QMS expert *

Currently we do not have QMS / 13485 expert in our organization
Yes, we have QMS/13485 documentation expert.
Will appoint if required.

In Vitro Device Name *

Type of Device

Intended use of the device *

What is the purpose of this device?

GMDN Code

Find GMDN Code from the below link. https://www.gmdnagency.org/account/login?ReturnUrl=/Terms/Search

EMDN Code

Find EMDN Code from the below link. https://webgate.ec.europa.eu/dyna2/emdn/

IVDR Code *

Find IVDR Code from the below link. https://www.i3cglobal.com/wp-content/uploads/2024/02/IVDR-CODES.pdf

Brand Name / Trade Name

Number of Models / Varients

Device risk class as per IVDR *

Device Usage

Is the Device Packed Sterile

Yes
No

Is the Device Packed with Accessories

Yes
No

Is the Device Packed with Consumables

Yes
No

Submitter Name *

Designation / Job Title *

Phone *

Email *

IVDR CE MARKING PROPOSAL REQUEST